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isocertificationinfrance · 7 months ago

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The Road to CE Certification: A Practical Handbook

What is Ce mark Certification in Bangalore?

The CE mark, which stands for Conformité Européenne, is a certification symbol that indicates that a product meets the requirements of European Union (EU) directives and suggestions. CE Certification in Bangalore is not part of the EU, the CE mark is required for products exported to the EU market. This certification ensures that items meet specific protection, health, and environmental requirements, encouraging free circulation throughout the EU.

The CE mark is a notification by the manufacturer that the product meets EU requirements. It is required for many product commands, including devices, medical equipment, manufacturing items, and accessories. There, we should have items marketed and traded freely in the European Economic Area (EEA) without the winning device of additional super conformity tests in each member of a.

WHY DO WE NEED CE MARKING CERTIFICATION?

As a producer or importer in Bangalore looking to export products to the European market, you must guarantee that your products meet the essential EU rules and regulations for CE marking. It entails determining if the product complies with applicable directives and standards, as well as accepting responsibility for compliance with EU legislation.

CE marking certification ensures that items meet the EU's health, safety, and environmental protection regulations. It boosts product credibility, builds customer trust, and broadens market reach in the EEA. Without CE marking certification, exporting products to the European market is difficult and may result in entrance restrictions or rejection.

Benefits of Ce mark Certification:

Market Access: CE Implementation in Bangalore mark allows companies in Bangalore to enter the EU market, increasing their opportunities to do business with European countries.

Competitive Advantage: The CE mark improves product confidence for confirming compliance with quality and protection requirements. This might provide organizations with a competitive advantage in the global marketplace.

Legal Compliance: Achieving the Ce mark displays the dedication of thinking to jail compliance, lowering the risk of criminal difficulties and noncompliance outcomes.

Consumer Confidence: Consumers in the EU value CE-marked product safety and quality, which fosters confidence in the offered equipment.

Global Recognition: While the CE mark is relevant to the EU market, it is also recognised and revered around the world, helping to the overall brand image.

Ce certification Process:

goods Classification: Determine which EU directives and needs apply to the goods. Different products come under the excellent directives and compliance requirements category.

Conformity Assessment: Perform crucial inspections to ensure that the product meets EU criteria.CE Services in Bangalore may also include documentation testing and, in some cases, the engagement of a Notified Body — a business organization-specific business enterprise with the important, useful assistance of an EU member country — to examine product conformity.

Technical documentation: Prepare comprehensive technical documentation that demonstrates compliance with applicable requirements. This documentation acts as proof of conformity and a desire to be investigated alongside the valued property of the relevant authorities.

Affixing the CE Mark: Connect the CE mark to the product or package once conformity has been established. The CE mark aims to be visible, legible, and indelible.

Declaration of Conformity: Issue a Declaration of Conformity, which is a report confirming that the product conforms with applicable EU directives. This file will be saved to the file and made available on request.

How to Obtain CE Mark Certification in Bangalore?

Wondering How to Find CE Mark Consultants in Bangalore? We provide exceptional CE mark certification auditors to aid organizations in following the recommendations given by the global organization for standardization and obtaining CE mark certification in Bangalore. We will work together to help you with your certification questions and needs. Simply send an email to [email protected] or request a free estimate from us for the CE mark price in Bangalore. If you would like to learn more about our session technique, please visit our website at www.b2bcert.Com. We would be happy to assist you.

For more information, visit CE Registration in Bangalore

#CE Certification in Bangalore #CE Consultants Services in Bangalore #CE Registration in Bangalore

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omcmedicalblog · 1 year ago

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MDCG Guidance for Manufacturers of Class I Medical Devices

A medical device’s intended use and inherent risks must be considered when determining its MDR classification. Class I devices pose less risk to patients and end users, as under the previous MDD. The new Regulation EU MDR 2017/745 has added extended rules, leading some devices to fall under Class IIa, IIb, or even III.

This document is intended to guide Class I medical device manufacturers (excluding custom-made devices) that sell products bearing their name or trademark on the Union market to comply with MDR requirements. This guidance should also apply when an importer, distributor, or any other legal entity takes on the obligations owed by manufacturers.

The class I manufacturer must also hire a Notified Body (NB) to perform a conformity evaluation if medical devices are to be provided sterile, have measuring functions, or are reusable surgical instruments. For the NB to be qualified to conduct such a conformity assessment, the specific medical device in question must come within the purview of the Notified Body’s designation.

Large and mid-sized medical device manufacturers must also properly designate at least one individual in charge of regulatory compliance, but micro and small companies can function better by having a regulatory expert.

It is also important to designate an authorised representative residing within the EU if the manufacturer is registered outside of the EU. A foreign manufacturer must specifically issue a mandate outlining the representative’s duties and authority. It is also crucial to note that not all responsibilities associated with the medical equipment can be assigned.

The manufacturer must adequately preserve all the records required to verify compliance with the relevant requirements so they may be made available to the regulatory body upon request.

Steps to placing Class I medical devices on the market:

Manufacturers must ensure compliance with each of the following requirements if they plan to commercialise Class I medical devices. Please be aware that some of the outlined requirements are interconnected and can be completed in a different sequence than that which is shown.

The manufacturer will carry out a gap analysis for Class I devices that have already been released onto the market in compliance with the MDD to ensure that all of the below-listed requirements were satisfied at the time the MDR was applied.

The whole procedure includes a set of mandatory steps, including:

Step 0: Integrate MDR in the Quality Management System (QMS)

The manufacturer’s QMS should be appropriately linked with the standards outlined in the MDR. To ensure compliance with the following requirements, this will enable the correct assessment or decision to be taken and the appropriate documented evidence to be produced.

Step 1: Confirm product as a medical device

The intended purpose and the product’s mode of action are reviewed as per Article 2(1) of the MDR to ensure that the product qualifies as a medical device. If a product is assigned multiple intended purposes, it will qualify as a medical device only if all the intended purposes are covered in Article 2(1).

In the case of products identified as more than one category, the relevant legislation requirements will have to be followed. Despite not being medical devices in and of themselves, accessories to medical devices are subject to MDR regulations and qualify as devices under the MDR definition.

However, the MDR does not include accessories to devices covered by it as per Annex XVI of the MDR.

Step 2: Confirm product as a Class I medical device

The product has to be confirmed if it can be classified as a class I device as per Annex VIII of the MDR. Products previously classified as class I under MDD should be reviewed according to the classification rules of MDR to confirm if reclassification is required.

The MDD guideline cannot be used for devices that were moved from Class I to higher risk classes by the adoption of the MDR. The intended use of the device and any inherent risks related to the period of use, the part of the body, whether it is active or not, and whether it is invasive or non-invasive will determine how the classification standards are applied.

The classification rule with the highest class should be applied if the device in question falls under the purview of more than one classification rule due to its attributes.

Step 3: Procedures before placing on the market

a) Meet the General Safety and Performance Requirements (GSPR)

The devices will adhere to the general safety and performance standards outlined in Annex I of the MDR, considering the intended purposes that their manufacturers had provided.

The Risk management system is a continuous iterative process throughout the entire lifecycle of the product, established by the manufacturer that will enable the identification and analysis of the risks related to each device, the estimation and assessment of the risks associated with those risks, the elimination or control of residual risks, and the evaluation of the adopted measures based on the data gathered from the PMS system.

When a harmonised standard is in place, but a manufacturer chooses to use another reference, implementing that reference should, at the very least, ensure the same level of performance and safety.

Compliance with the relevant harmonised standards will give rise to a presumption that the MDR’s requirements, or portions of them, are also complied with.

If there are available standard specifications, the manufacturer must adhere to them unless they can adequately demonstrate that they have chosen a solution at least as effective and safe. The clinical evaluation processes, risk management, and PMS must be interdependent and updated regularly.

b) Conduct clinical evaluation

As part of the MDR’s technical documentation requirements, all devices—regardless of risk classification—require a clinical evaluation. The level of clinical evidence required to show compliance with the pertinent general safety and performance requirements listed in Annex I, which is obtained by considering the characteristics of the device and its intended purpose, shall be specified, and justified by the manufacturer.

Manufacturers must prepare, carry out, and record a clinical evaluation in compliance with Article 61 and Part A of Annex XIV to accomplish this.

Consideration of available alternative treatment options, the incorporation of clinical data and the acceptability of the benefit-risk ratio are required for carrying out a clinical evaluation.

Additional clinical data will be acquired or developed by clinical investigations if the currently available clinical data are insufficient to establish compliance with the MDR.

If the clinical data currently available for a device that is currently certified under Directive 93/42/EC is insufficient to show compliance with MDR, then post-market clinical follow-up studies of the device may be used to gather more clinical data.

Even data from the general post-market follow-up may occasionally be enough to close the difference.

a) Prepare technical documentation

The manufacturer is responsible for creating and maintaining the technical documentation to prove that their products adhere to the MDR’s technical specifications. Under Annex II and III, this technical documentation must be prepared before the EU declaration of compliance is drawn.

The manufacturer will develop and provide the technical documentation and, if applicable, it’s summary in a way that is unambiguous, clear, well-organised, and easy to search.

The manufacturer shall provide the CA, the authorised representative (where applicable), and NB with access to the technical documents (when applicable).

After reviewing the general safety and performance standards, as well as the pertinent technical provisions of the MDR, the technical documentation will be developed.

b) Request Notified Body involvement

Class I devices do not require the engagement of an NB for MDR compliance. But the manufacturer must follow the guidelines outlined in Chapters I and III of Annex IX or Part A of Annex XI of MDR when the product is a sterile equipment, measuring instrument, or reusable surgical tools.

For the relevant codes and corresponding types of devices as established by Regulation (EU) 2017/2185, manufacturers may select any NB designated in accordance with the MDR.

c) Prepare Instructions for Use and Labelling

Any safety and performance information required for a device’s safe usage and identification of the device should be provided along with the device by the manufacturer and/or the authorised representative, considering the possible users’ training and knowledge.

This data is included on the label, in the device packing, and in the instructions for use. Class I devices do not need instructions for use if they may be operated effectively and securely without them, deviating from the general rule.

Since Class Ir devices will need instructions for reprocessing (cleaning and sterilisation), an exception is most likely proposed.

Labelling and instructions for use must be written in accordance with national language regulations. There will be versions of the labelling and IFU in the technical documentation (in each pertinent national language).

The requirements regarding the information to be supplied with the device will be found in Annex I, Chapter III (23).

Step 4: Check compliance with general obligations for manufacturers

The manufacturer shall ensure that the general obligations for manufacturers outlined in Article 10 are met before releasing a device for sale.

Implementing a suitable QMS that will most effectively assure compliance with the MDR, such as through an internal audit, will receive special consideration. The QMS shall be documented, applied, maintained, updated regularly, and developed continuously, and it will at least include the following elements:

A strategy for regulatory compliance

Identification of applicable general safety and performance requirements and exploration of options to address those requirements

Responsibility of the management

Resource management, including selection and control of suppliers and sub-contractors

Risk management

Clinical evaluation, including post-market clinical follow-up (PMCF)

Product realisation, including planning, design, development, production and service provision

Verification of the UDI assignments

Setting up, implementation and maintenance of a post-market surveillance system

Handling communication with competent authorities, notified bodies, other economic operators, customers and/or other stakeholders

Processes for reporting serious incidents and field safety corrective actions in the context of vigilance

Management of corrective and preventive actions and verification of their effectiveness

Processes for monitoring and measurement of output, data analysis and product improvement.

According to applicable Union and national law, either natural or legal persons may seek compensation for harm brought on by a defective equipment.

In order to protect themselves against potential responsibility under Directive 85/374/EEC, manufacturers must take precautions that are commensurate to the risk class, type of device, and size of the business. These steps must not compromise further protective measures under national legislation.

Step 5: Draw-up the EU Declaration of Conformity

The process by which the manufacturer, who complies with the standards established by Article 52(7), certifies that the devices in question comply with the requirements of the MDR that apply to them is referred to in Article 19 as the EU declaration of conformity.

The CA will have access to the declaration of compliance, which must include, at a minimum, all of the data referred to in Annex IV. The manufacturer will regularly update the EU declaration of conformity and translate it into the official language(s) required by the Member States where the product is sold.

Suppose a device is subject to additional Union laws in addition to the MDR that also call for an EU declaration of conformity. In that case, the manufacturers will create a single EU declaration of conformity that refers to all applicable Union laws.

By creating the EU declaration of conformity, the manufacturer accepts liability for the device’s regulatory compliance with all relevant Union legislation.

For class Ir, Im, and Is devices, the manufacturer must obtain an EC certificate from NB per Annex IX, Chapters I and III, or Annex XI, Part A before applying a CE mark.

Step 6: Affix the CE marking

All Class I medical devices on the market must display the CE conformity label, which must be visible, readable, and permanent. It may be applied to the item or its sterile packaging. The CE marking must be applied to the package in cases where such affixing is impossible or unwarranted due to the nature of the device. The CE certification must be visible on all sales packaging and the instructions for use.

Placing the CE mark on a medical device signifies that it complies with all applicable safety and performance standards and is approved for marketing in the EU. The CE marking will be accompanied by the identification number of the relevant NB in the case of Class I medical devices placed on the market in a sterile condition, devices with measurement functions, and/or reusable surgical tools.

Affixing marks that could lead third parties astray about the significance of the CE marking is banned. Other extra markings may be applied to the product, the packaging, or the usage instructions, but they must not obscure or obstruct the CE marking.

The CE marking format will follow Annex V requirements. The minimum dimensions required for the CE mark may not apply to very small devices.

Step 7: Registration of devices and manufacturers in Eudamed

A streamlined approach might be used for medical devices that were previously put on the market per the Directives, provided that the manufacturer evaluates the gap and ensures that all regulations are properly followed.

A Class I medical device manufacturer must register the product with Eudamed before putting it on the market. Suppose the information listed in Section 1 of Part A of Annex VI has not already been registered in accordance with Article 31. In that case, the manufacturer must submit it to the electronic system in order to register the device. The information referred to in Section 1 of Part A of Annex VI will be given to that electronic system before applying to the NB in situations where the conformity assessment method necessitates the engagement of an NB in accordance with Article 52.

Following the CA’s validation of the manufacturer’s data in Eudamed, the manufacturer will receive an SRN from the aforementioned electronic system. To fulfil its duties under Article 29, the manufacturer will use the SRN when submitting an application to an NB for a conformity assessment and to gain access to Eudamed.

The registration of a device in Eudamed by the manufacturer includes:

Assigning a UDI-DI (with a Basic UDI-DI) as described in Part C of Annex VI to the device in accordance with the issuing entity’s policies mentioned in Article 27(2) and adding the UDI-DI (with a Basic UDI-DI) to the UDI database along with the other core data elements pertaining to that device mentioned in Part B of Annex VI.

Entering the data referred to in Section 2 of Part A of Annex VI, excluding Section 2.2 thereof, or, if previously provided, validating the data, and then keeping the data current up to date.

This document summarises the information presented above and outlines how Class I medical devices should be introduced to the EU market. The guidance’s scope also includes reusable surgical instruments (Class Ir), sterile medical devices (Class Is), and devices with measurement capabilities. These medical devices all need a Notified Body to be involved in pre-marketing procedures.

Originally Published at: https://omcmedical.com/mdcg-guidance-manufacturers-class-i-medical-devices/

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izielhealthcare · 1 year ago

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MDD to MDR Transition for Medical Devices

The transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) marks a significant change in the regulatory framework for medical devices in the European Union (EU). The MDR came into full effect on May 26, 2021, replacing the MDD and introducing more stringent requirements for the marketing and oversight of medical devices.

Here are some key points to consider regarding the transition from MDD to MDR for medical devices:

1. Scope and Classification: The MDR has a broader scope and includes a wider range of medical devices than the MDD. It introduces new classification rules, which might result in the reclassification of some devices.

2. Conformity Assessment: The MDR emphasizes a risk-based approach to conformity assessment. It introduces stricter requirements for clinical evidence and post-market surveillance. Manufacturers need to provide more comprehensive data on safety, performance, and clinical benefit.

3. Unique Device Identification (UDI): The MDR mandates the use of Unique Device Identifiers (UDIs) for better traceability of devices throughout their lifecycle. UDIs provide information about the device's identity, origin, and production history.

4. Post-Market Surveillance: The MDR places greater emphasis on post-market surveillance and vigilance. Manufacturers are required to actively monitor the performance of their devices on the market and report any incidents or safety concerns.

5. Economic Operators: The MDR introduces new roles for economic operators in the supply chain, including importers and distributors. These entities have specific responsibilities related to device oversight and reporting.

6. Clinical Data Requirements: The MDR sets higher standards for clinical data and requires more extensive clinical evaluation for devices, especially for high-risk devices. Clinical data must support the device's safety and performance claims.

7. Notified Bodies: Notified Bodies play a crucial role in the conformity assessment process. The MDR requires stricter criteria for designation and oversight of Notified Bodies to ensure consistency and reliability in the assessment process.

8. Transitional Period: There was a transition period for manufacturers to comply with the MDR. Devices certified under the MDD could continue to be placed on the market until May 26, 2024, if the MDD certificate remained valid. However, for new devices, the MDR requirements are applied immediately after implementation.

9. Legacy Devices: After the transition period, devices that were certified under the MDD and placed on the market could still be used, provided they continue to meet their intended purpose and do not compromise patient safety. However, any modifications to these devices may trigger the need for MDR compliance.

It's important for manufacturers, importers, distributors, and other stakeholders in the medical device industry to understand the new requirements outlined in the MDR and ensure compliance to continue marketing and using medical devices in the EU market. The transition involves comprehensive changes, including adjustments to processes, documentation, and quality management systems to align with the new regulation. It's recommended to consult with legal experts and regulatory consultants to navigate the transition successfully.

IZiel team of specialists and quality professionals look forward to support more medical device companies to file their devices under the MDR 2017/745.

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meeraoperon · 3 years ago

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MDD to New MDR Classification of Medical Devices

The prerequisites for MDR classification for medical devices are basically equivalent to those in the present Medical Devices Directive (MDD). The EU MDR is shaking up the medical device industry and the order rules have not been left immaculate. The MDR decides the congruity assessment course for the device. While the order principally worries of the maker, if the device falls into Classes IIa, IIb, or III it has suggestions for the Notified body.Before medical devices manufacturers can lawfully CE stamp their products in Europe, they should consent to the fitting medical devices order or guideline set out by the EU Commission. It is crucially critical to know the right medical device classification for your product before CE marking your devices. A classification impacts the administrative prerequisites for your devices, just as the endorsement course and its related expenses.

EU MDR classifications for medical devices

One of the first considerations for medical devices manufacturers who are seeking to place their products in the European markets is to determine which the appropriate classifications for their devices are.The MDR classification of the device will impact on how and when you will engage with your Notified Body. As the market transitions from Medical Devices Directives (MDD) and the Active Implantable Medical Devices to the Medical Devices Regulation, the device manufacturers must note the changes in the requirements for device classification. For example, devices that had previously been included in the Active Implantable Medical Device Directives (MDD) are now covered in the Medical Device Regulation (MDR).

EU MDR Medical Device Classification Rules The Medical Device Classification EU rules, which are based on the vulnerability of the human body, should take into account the potential risks associated with the technical design and manufacture of the devices. Read more - MDR classification Visit Us - Operon StrategistContact details – Phone no - 93702 83428 Mail id – [email protected]

#mdr device classification #mdd vs mdr classification rules #mdd vs mdr #mdr device classification rules #mdr classification #eu medical device classification rules #mdr classification rules annex viii #ce mdr classification #mdr classification examples #mdr risk classification #mdd to mdr changes

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abhibediskar · 4 years ago

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Get your Medical devices CE Marked

As the Coronavirus (COVID-19) outbreak evolve all over the world, safety and wellbeing is the topmost priority, so to safeguard people by managing the risk of infection within the operation; all we are counting to work for the safety and security, and wellbeing by following all necessary and required possible steps to put the safety of patients, our clients, and own people first.

Products that are classified as medical devices range from a band-aid to hearing aid i.e. from simple to complex in the market. Medical devices in the market need to be accountable to be safe for the consumer to satisfy the need of the user and patients.

CE Marking is the medical device manufacturer’s claim that products are safe for usage and have passed all the relevant European Medical Device Directives and are ready to be placed in the market. These Directives in the European Union (EU) outlines the safety and performance requirements for medical devices. In this context, the executive ensures that the products (Medical Devices) are made available for distribution or use (e.g. to a distributor, healthcare professional, or patient) for the first time or recently refurbished and whether it is provided with or without charge.

How to place CE Marking on the Medical Devices

Before placing a CE marking on a medical device, the device must follow the definition of Medical Devices and be accurately classified under the classification rules laid down in annex IX of the executive order on medical devices. The classifications of the Medical Devices are based on the risk associated with them. Class I (Im, Is), Class IIa, Class IIb, and Class III. Class I is associated with the lowest risk, while class III is associated with the highest risk medical devices.

CE Marking is also based on the class of these medical devices. The manufacturer of class I medical devices is self-responsible for the CE marking process. On the other hand, Class III manufacturers need to involve notified bodies in the certification of medical devices belonging to higher-risk classes.

Also, Check --->> CE Marking Certification in India

Who are notified bodies?

Notified bodies are authorized bodies to ensure that manufacturers have met all the required technical documentation and perform quality control for processes and products that may pose a significant risk.While CE marking the devices the manufacturer must involve the notified body for verifying its authenticity of the product, before marketing any medical devices, except class I devices. Class II and Class III involve sterile products or a measuring function, as well as in vitro diagnostic devices that are not covered by Annex II.

Documentation

The technical documentation should be established based on safety and performance requirements. The purpose is to document the properties of the product to evaluate the quality, safety, and performance of the devices before getting placed on the market.

In addition, the documentation must comprise all clinical investigations and evaluations that are analyzed and assessed to document that the device complies with the essential requirements as to safety and performance. It also contains the risk analysis as the central point of the document to assess whether the risks associated with using the product are acceptable with the benefits for the individual user or patient.

CE Marking

Once the manufacturer has signed the EU declaration, the CE mark can be placed on the device. The CE marking should be placed visibly, legibly, and indelibly. The CE mark must also be affixed to the packaging of the device that ensures sterility of the device. The identification number for a notified body has to be placed below the CE mark.

#CE Marking #ce marking certification

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anewsbuddy · 4 years ago

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MDCG Releases Guidance On Classification Rules For IVDs - Food, Drugs, Healthcare, Life Sciences - UK - Mondaq News Alerts

MDCG Releases Guidance On Classification Rules For IVDs – Food, Drugs, Healthcare, Life Sciences – UK – Mondaq News Alerts

UK: MDCG Releases Guidance On Classification Rules For IVDs 23 December 2020 Bristows To print this article, all you need is to be registered or login on Mondaq.com. The European Commission’s Medical Device Coordination Group (MDCG) recently published its guidance on the classification of in vitro diagnostics (IVDs) under the In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746. This document…

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#health #weight loss

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operonstrategist98 · 5 years ago

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MDD to New MDR Classification of Medical Devices

Before medical devices manufacturers can lawfully CE stamp their products in Europe, they should consent to the fitting medical devices order or guideline set out by the EU Commission. It is crucially critical to know the right medical device classification for your product before CE marking your devices. A classification impacts the administrative prerequisites for your devices, just as the endorsement course and its related expenses.

The number of rules in the MDR classifications has expanded from 18 to 22 and extra changes have been made to existing guidelines, which means numerous devices have new classifications. One of the important changes with the EU MDR is that medical device manufacturers will feel as they progress to conform to the new guideline is the adjustment in prerequisites for devices classifications. As medical devices classification change so do the prerequisites for manufacturers. The MDR will apply to specific products not directed through the MDD, such devices without an expected medical reason like non – corrective contact lenses.2 The MDR will likewise uncommonly manage devices joining nonmaterial’s and devices fabricated with non – feasible human tissue, which are at present absolved from the MDD.

With new guidelines likewise come classifications changes significant to specific devices. All dynamic implantable devices and their accessories will be considered as Class III. Any substance-based devices expected to be utilized by means of a body orifice or applied on the skin may not be a class I, so any substance – based devices at present in class I will be up – classified with the new regulation. Any manufacturer with a device that will be up – classified with the MDR must consent to the stricter necessities and will probably need to draw in their body more. The MDR classification specifies that the products are specifically intended for the cleaning, disinfection or sterilization of medical devices.

We at Operon Strategist help you in the process of making a defined and comprehensive technical file with all product details required for CE marking.

We’ll also provide assistance in your process of making technical file and review it at every step for compliance.

EU MDR classifications for medical devices

The MDR classification of the device will impact on how and when you will engage with your Notified Body. As the market transitions from Medical Devices Directives (MDD) and the Active Implantable Medical Devices to the Medical Devices Regulation, the device manufacturers must note the changes in the requirements for device classification. For example, devices that had previously been included in the Active Implantable Medical Device Directives (MDD) are now covered in the Medical Device Regulation (MDR).

Medical Device Classification as per MDR

As per MDR Article, 51 Medical Devices are divided into class I, IIa, IIb and class III, taking into account the intended purpose of the devices and their inherent risks. Medical Device classifications are mainly based on the following factors:

Does the device have a standalone action?

How long the device is in continuous use in the human body?

Is it an invasive device or surgically invasive Medical Device?

Is it an implantable or active medical device

Does the Medical Device serve the purpose by the use of a certain drug?

The Medical Devices Classification in the European Union new MDR is outlined in ANNEX VIII, Chapter I and classification Rule mentioned in Chapter III. This chapter includes definitions of the terminology used in the medical devices guidance document for the classification of Medical Device.

The Medical Device is classified into:

Class 1

Class 1 Sterile

Class 1 Measuring

Class 1 Reusable

Class 11a

Class 11b

Class 111

EU MDR Medical Device Classification Rules

The Medical Device Classification EU rules, which are based on the vulnerability of the human body, should take into account the potential risks associated with the technical design and manufacture of the devices.

You’ll find all those rules on the Medical Device Regulation MDR 2017/745 Annex VIII

Rule 1– Non-invasive devices

Rule 2 – Non-invasive devices intended for channelling or storing (Which includes cells)

Rule 3 – Non-invasive devices that modify the biological or chemical composition of blood, body-liquids, other liquids and cells

Rule 4 – Non-invasive devices in contact with injured skin or mucous membrane

Rule 5 – Devices invasive in body orifices

Rule 6 – Surgically invasive devices for transient use

Rule 7 – Surgically invasive devices for short term use

Rule 8 – Surgically invasive devices for long term use and implantable (including any device administering medicinal products, surgical mesh or spinal disc)

Rule 9 – Active therapeutic devices intended to exchange or administer energy

Rule 10 – Active devices for diagnosis & monitoring, emit ionizing radiation

Rule 11 – Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes (from class I to class III)

Rule 12 – Active devices intended to administer and/or remove medicinal products, body-liquids or other substances

Rule 13 – All other active devices

Rule 14 – Devices incorporating a medicinal substance including human blood or plasma

Rule 15 – Contraception or prevention of the transmission of sexually transmitted diseases

Rule 16 – Specific disinfecting, cleaning and rinsing devices

Rule 17 – Devices specifically intended for recording of diagnostic images generated by X-ray radiation

Rule 18 – Devices utilizing non-viable tissues or cells of human origin or tissues of animal or derivatives.

Four new rules:

Rule 19 – Devices incorporating or consisting of nonmaterial

Rule 20 – Invasive devices with respect to body orifices to administer medicinal products by inhalation

Rule 21 – Substances or of combinations of substances that are intended to be introduced into the human body via a body orifice or applied to the skin and that are absorbed

Rule 22 – Active therapeutic devices with an integrated or incorporated diagnostic function which significantly determines the patient management.

Adjustments to the medical device classification system are not as problematic as those for IVDs yet will expect manufacturers to roll out some significant improvements. A large number of these progressions are a consequence of the old directives not considering the degree of the obtrusiveness and potential toxicity quality of certain devices. The MDR classifications of devices are into four classes: class I, class IIa, class IIb and class III. How they are classified relies upon 23 principles that think about their capacity, the risk to patients and the manufacturer’s intended use. There are a specific set of classification rules for four unique classes of medical devices: non-obtrusive, intrusive, dynamic and uncommon principles for inventive devices that incorporate different substances. Medical devices manufacturers ought to know that it is completely basic to classify these devices effectively from the earliest starting point as it directs the manufacturing prerequisites, clinical assessment and congruity evaluation. To ere in favour of alert, manufacturers should survey all present and future devices to guarantee consistence with the changed classification system. More info visit:https://www.operonstrategist.com/

#MDR classification #EU MDR classifications for medical devices #CE marking #Medical Devices Classification

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un-enfant-immature · 6 years ago

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Contraception app Natural Cycles’ Facebook ad banned for being misleading

Natural Cycles, a Swedish startup which touts its body temperature-based algorithmic method for tracking individual fertility as an effective alternative to hormonal birth control, has been wrapped by the UK advertising regulator which today upheld three complaints that an advert the company ran last year via Facebook’s platform was misleading.

The regulator has banned Natural Cycles from running the advert again, and warned it against exaggerating the efficacy of its product.

The ad had stated that “Natural Cycles is a highly accurate, certified, contraceptive app that adapts to every woman’s unique menstrual cycle. Sign up to get to know your body and prevent pregnancies naturally”, and in a video below the text it had also stated: “Natural Cycles officially offers a new, clinically tested alternative to birth control methods”.

“We told Natural Cycles Nordic AB Sweden not to state or imply that the app was a highly accurate method of contraception and to take care not to exaggerate the efficacy of the app in preventing pregnancies,” said the Advertising Standards Authority (ASA) handing down its decision.

The company has leaned heavily on social media marketing to target its ‘digital contraception’ app at young women.

While Natural Cycles gained EU certification for its app as a contraceptive in February 2017, and most recently FDA clearance for marketing the app as a contraception in the US (with the regulator granting its De Novo classification request this month), those regulatory clearances come with plenty of caveats about the complexity of the product.

The FDA, for example, warns that: “Users must be aware that even with consistent use of the device, there is still a possibility of unintended pregnancy.”

At the same time, Natural Cycles has yet to back up the efficacy claims it makes for the product with the scientific ‘gold standard’ of a randomized control trial. So users wanting to be able to compare the product’s efficacy against other more tried and tested birth control methods (such as the pill or condoms) are not able to do so.

No birth control method (barring abstention) is 100% effective of course but, as we’ve reported previously, Natural Cycles’ aggressive marketing and PR has lacked nuance and attempted to downplay concerns about the complexity of its system and the chance of failure even as the product’s performance is impacted by multiple individual factors — from illness, to irregular periods.

In the ruling, the ASA flags up the relative complexity of Natural Cycles’ system vs more established forms of contraception — pointing out that:

The Natural Cycles app required considerably more user input than most forms of contraception, with the need to take and input body temperature measurements several times a week, recording when intercourse had taken place, supplemented with LH measurements, abstention or alternative methods of contraception during the fertile period.

The company also remains under investigation in Sweden by the medical regulator after a local hospital reported a number of unwanted pregnancies among users of the app.

Despite all that, Natural Cycles’ website bills its product as “effective contraception”, claiming the app is “93% effective under typical use” and making the further (and confusing worded) claim that: “With using the app perfectly, i.e. if you never have unprotected intercourse on red days, Natural Cycles is 99% effective, which means 1 woman out of 100 get pregnant during one year of use.”

Perfect use of the app actually means a woman would accurately perform daily measurement of her body temperature without fail or fault, and before she’s even sat up in bed, at least several times a week, correctly inputting the data. Forgetting to do so once because — say — you got up to go to the toilet or were otherwise interrupted before taking or inputting a reading could constitute imperfect use.

The BBC spoke to a women who says she made the decision to use the app after seeing that 99% effective claim in Natural Cycles’ marketing on Instagram — and subsequently fell pregnant while using it. “I was sort of sucked into this “99% effective” [claim],” the women told the broadcaster. “You know “even more effective than the pill”… What could possibly go wrong?”

In its ruling, the regulator said it investigated two issues related to the advert run by Natural Cycles on Facebook on July 20, 2017, and both issues were upheld.

The complaints were that Natural Cycles’ advert included misleading and unsubstantiated claims — specifically that the product was: 1. “Highly accurate contraceptive app”; and 2. “Clinically tested alternative to birth control methods”.

Natural Cycles told the ASA that the latter claim is in fact a quote from a Business Insider article which it “considered to be correct” and had thus reproduced in its marketing.

After taking expert evidence, and reviewing three published papers on accumulated data obtained from the app, the regulator deemed the combination of the two claims to be misleading.

It writes:

We considered that in isolation, the claim “clinically tested alternative to birth control methods” was unlikely to mislead. However, when presented alongside the accompanying claim “Highly accurate contraceptive app”, it further contributed to the impression that the app was a precise and reliable method of preventing pregnancies which could be used in place of other established birth control methods, including those which were highly reliable in preventing unwanted pregnancies. Because the evidence did not demonstrate that in typical-use it was “highly accurate” and because it was significantly less effective than the most reliable birth control methods, we considered that in the context of the ad the claim was likely to mislead.

The ASA also found the advert to have breached rules for substantiation and exaggeration of marketing messages in the Medicines, medical devices, health-related products and beauty products category, as well as being misleading.

At the time of writing Natural Cycles had not responded to requests for comment.

#TechCrunch

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i3cglobalblog · 4 years ago

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Determination of the Medical Device Classification and the corresponding classification rule is the first step in the EU CE Marking process.

eu medical device classification

#eu medical device classification

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endenogatai · 6 years ago

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Natural Cycles contraception app told to clarify pregnancy risks

A multi-month investigation by Sweden’s Medical Products Agency into a number of unwanted pregnancies among users of ‘digital contraception’ app Natural Cycles has been closed after the startup agreed to clarify the risk of the product failing.

But, on the self-reported data front, the agency said it was satisfied the number of unwanted pregnancies is in line with Natural Cycles’ own clinical evaluations which are included in the certification documentation for the product.

In its marketing and on its website Natural Cycles describes the app-based system as “93% effective under typical use” — a finding that’s based on a clinical study it conducted of more than 22,000 of its users.

The investigation by Sweden’s MPA began around eight months ago, after a number of users in Natural Cycle’s home market had reported unwanted pregnancies to a local hospital — which then reported the app to the regulator.

The Natural Cycles app uses an algorithm to track fertility by monitoring the user’s menstrual cycle. The process requires women take their body temperature at least several times a week, and do so first thing in the morning, inputting the data into the app which is designed to adapts its ‘fertile’ or ‘not fertile’ predictions to each user’s cycle.

Several users have reported falling pregnant while using the app. But the proportion of women who have done so (at least in Sweden) is in line with efficacy rates reported by Natural Cycles, according to the regulator’s assessment.

Earlier this year the MPA said it had received “approximately 50 complaints” related to unwanted pregnancies in users of the app. But late last week it announced it had concluded its assessment of the app — which it said focused on “product safety, instructions for use and post market surveillance documentation in order to confirm if the product is in compliance with regulations”.

As well as looking at parts of the certification documentation for Natural Cycles, the agency says it assessed monthly reports of unwanted pregnancies among active app users in Sweden, covering a six-month period — with pregnancy data supplied by the company itself on a month by month basis during the first half of 2018.

The agency found the number of reported unwanted pregnancies reported by users to be in line with Natural Cycles’ certification documents for the product, finding a failure rate in typical use of 6.9%.

But it also asked the company to clarify the risk of unwanted pregnancies in instructions for the app.

“Our conclusion is that the number of unwanted pregnancies during the assessed time period is consistent with data shown in the clinical evaluation included in the certification documentation. Since it is important that a contraception app is correctly used, we requested the manufacturer to clarify the risk of unwanted pregnancies in the instructions for use and in the app. These issues have been addressed by Natural Cycles and thereby our review is completed,” said Mats Artursson, investigator at the agency in a statement.

As we reported earlier this year, the startup has lent heavily on aggressive social media marketing of its novel ‘digital contraception’ method — which has sometimes appeared to downplay the risk of failure for what is undoubtedly a relatively complex contraception option, given it requires users to consistently self-monitor (and accurately measure their body temperature) as well as use alternative contraception on days when the app informs them they are fertile.

Natural Cycles admits that factors such as illness, disrupted sleep, drinking alcohol and having an irregular menstrual cycle can have a negative impact on the accuracy of its algorithmic fertility predictions. And says itself that the method is not a suitable contraception choice for every individual.

Nor does the app offer any protection against STDs — unless users combine it with additional barrier methods of contraception.

But despite that, until very recently on its website (and in some of its marketing) Natural Cycles has been making the misleading claim that its contraception app is “99% effective” if used “perfectly”. (Perfect use implying, well, superhuman use.)

And just last month the company was wrapped on the knuckles by the UK’s Advertising Standards Authority — which banned one of its social media ads for being misleading, also warning the company against exaggerating the efficacy of the app in preventing pregnancies.

The assessment by the Swedish MPA looks to have reached similar conclusions about certain aspects of the claims Natural Cycles’ has been making for the app.

When we covered the ASA’s ruling last month Natural Cycle’s website still included the misleading 99% ‘perfect use’ claim — within this confusingly worded paragraph: “With using the app perfectly, i.e. if you never have unprotected intercourse on red days, Natural Cycles is 99% effective, which means 1 woman out of 100 get pregnant during one year of use.”

It’s since scrubbed the paragraph from its website, focusing solely on the 93% effective stat — on which it now writes: “Natural Cycles is 93% effective under typical use, which means that 7 women out of 100 get pregnant during 1 year of use. Typical use effectiveness takes into account all possible reasons for becoming pregnant while using the app: from having unprotected sex on a red day, to the app wrongly attributing a green day or the chosen method of contraception on a red day having failed.”

It’s not clear whether Natural Cycles removed the 99% ‘perfect use’ claim as a result of the ASA ruling — or following the Swedish MPA’s assessment. (We’ve asked the company to clarify the exact changes it made related to the MPA’s findings, which the regulator also says relate to software versioning, and will update this story with any response.)

Its app gained certification as a contraception in the EU in February 2017, and went on to gain FDA clearance (via a De Novo classification request) this summer — giving the product a major credibility boost, even as regulatory clearances still come with plenty of caveats. (In the FDA‘s case it warns that: “Users must be aware that even with consistent use of the device, there is still a possibility of unintended pregnancy.”)

It’s also worth noting that it’s still the case that Natural Cycles has not carried out a randomized control trial to more robustly prove out the efficacy of the product, i.e. by using standard scientific methods.

Instead, users must rely on the findings of its self-selecting clinical study of its own users — which may have its own weaknesses, given that, for example, any user who fails to report an unwanted pregnancy to Natural Cycles would not be reflected in the data it’s providing to regulators.

Commenting on the conclusion of the Swedish MPA’s investigation in a statement, Natural Cycles CEO Raoul Scherwitzl said: “We are pleased that the MPA has concluded its investigation, following a review of our real-world effectiveness data. There has been a lot of discussion about this investigation, and we hope that it will provide some reassurance to women to see eminent bodies like the Swedish MPA and the US FDA in alignment based on the strength of our clinical evidence. We never doubted the effectiveness of our product since the number of reported pregnancies is monitored closely on a monthly basis — this is an ongoing responsibility that we commit to as part of operating in a regulated environment.”

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izielhealthcare · 4 years ago

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Steps for Getting CE Marking

All products meeting the definition of medical devices as defined by the EU regulations require CE marking before they can be sold in the EU. CE marking indicates that a product has been assessed by the manufacturer and meets EU safety, health, and environmental protection requirements. It is required for products manufactured anywhere in the world that are then marketed in the EU.

The product must comply with all the relevant MDD to MDR requirements of before affixing the CE marking to it. Although the compliance requirements are similar in many ways, the European route is thought to be less governmental, resulting in shorter times to market, greater acceptance rates of new devices, and lesser costs associated with obtaining conformity certification.

While the benefits of obtaining a CE marking are significant, regulations are always subject to change. New modifications to the European medical device requirements are making the process more similar to that of the FDA when it comes to establishing conformity.

By May 2021, a new Medical Device Regulation (MDR 2017/745) will go into effect throughout the European Union. Despite the changes, there still remains a clear path to establishing conformity and obtaining a CE marking that will allow your company to access European markets.

Steps

1. IDENTIFY THE APPLICABLE REQUIREMENTS OF THE REGULATIONS

1. CLASSIFY THE DEVICE AS PER THE RULES DEFINED FOR CLASSIFICATION OF MEDICAL DEVICES

2. IDENTIFY AN APPROPRIATE ROUTE TO CONFORMITY

3. ASSESSMENT OF THE PRODUCT’S CONFORMITY TO EU REQUIREMENTS

4. COMPILE THE TECHNICAL DOCUMENTATION, QMS & CLINICAL EVALUATION REPORT.

5. ASSESSMENT BY NOTIFIED BODY

6. MAKE A DECLARATION OF CONFORMITY AND AFFIX THE CE MARK

IZiel Healthcare has collaborated with Belgium based Obelis (European Authorized Representatives) to provide a “One-Stop Solution” to fully support Class I, IIa, IIb & III medical device manufacturers across USA, Europe & Asia. Typically, all MDD-MDR transition projects initiate with Gap Assessment. Gap Assessment is a crucial activity during MDR transition.

IZiel-Obelis collaboration would ensure to obtain conformity with the MDR (2017/745) requirements and maintain the CE Marking by developing Technical File & QMS Documentation, conducting Software Validation, writing CERs and providing EC Rep, EUDAMED, PRRC Services. Our experts are well equipped to conduct this activity with an analytical mindset, resolve any engineering requirements and develop robust regulatory strategy for medical device manufacturers.

#regulation #ce marking certification #usfda #processvalidation #technical design document #software validation

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meeraoperon · 3 years ago

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MDD to New MDR Classification of Medical Devices

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sheminecrafts · 6 years ago

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Natural Cycles contraception app told to clarify pregnancy risks

But it also asked the company to clarify the risk of unwanted pregnancies in instructions for the app.

Nor does the app offer any protection against STDs — unless users combine it with additional barrier methods of contraception.

The assessment by the Swedish MPA looks to have reached similar conclusions about certain aspects of the claims Natural Cycles’ has been making for the app.

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abhibediskar · 4 years ago

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CE Marking for Medical Devices

As the world faces the COVID-19 pandemic together, we would like to reassure you by taking extensive actions to safeguard people and patients' safety, by managing the risk of infection. These actions are in accordance with the World Health Organization (WHO), respective to local government.

To ensure the devices used for testing and in the whole procedure to treat the patient need to be safe and quality devices that do not cause any harm to the health and wellbeing of the patients and the users. Products that are classified as medical devices, must be accounted for and reassure the safety, as they are associated with additional risks. CE certifying medical devices requires a different approach of requirements because it determines the risks that your product may carry.

For your products to be placed on the European market, you need to understand and meet all the required Directives to ensure your product completes the CE Marking process efficiently and successfully. CE Marking Conformité Européenne expresses conformity with the European legislation, specifically with European directives and European regulations. For medical devices, the Medical Device Regulation MDR and the In-vitro Device Regulation IVDR fulfill the "essential requirements" as laid out in Annex I of MDD, respectively the "general safety and performance requirements to be followed" as laid out in Annex I of MDR. The second precondition the manufacturer performs is conformity assessment procedure depending on the risk.

Also, Check --->> CE Marking Certification in Sri Lanka

What are the classifications of Medical Devices?

Classifying your MDs is an essential step in the certification process. Under the Medical Device Regulation (MDR) 2017/745, MDs fall under four classes classification:

Class I

Class IIa

Class IIb

Class III

These classes are characterized under the risks involved in them, from lower to the highest.

The classification of your medical device depends on its characteristics described in Annex IX of the MDR 2017/745

For how long period for which the MD is in use?

Whether the MDs are surgically invasive?

Whether the MDs is an implant or active device in nature?

Whether the device contains a clearly defined medicinal substance?

Basis of classification

The initial point for certifying a medical device is defining the purpose of devices. The Intended Purpose will confirm whether your product is underlined under the definition of the Medical Devices and provide a basis for the rest of the certification process, including classification, evaluation, documentation, and labeling.

What Directives do MDs need to meet?

The EU Medical Device Regulation 2017/745 is the legislation for manufacturers to adapt to the MDR to be sold within the EU market.

The CE Marked Devices ensure the safety of the devices and the conformity of the requirements underlined by the legislation to make the product/devices acceptable by the public for use without concern about the risks involved.

CE-marked devices are thoroughly tested under the following EU directives by the third party for the conformity of the marking.

Also, Check --->> CE Marking Certification

Procedure to develop CE Marking for the medical devices

Navigating the CE marking process is as easy as the following steps:

1. Classify your product - Class I, IIa, IIb, and III according to the classification rules.

Class I- Devices with low risk such as external devices such as a bandage, etc;

Class IIa/b - Devices with medium risk such as electro-medical devices and;

Class III - Devices with high risk such as cardiovascular catheters

2. Determine your certification process based on the risk involved in the devices you manufacture.

3. Fulfill the essential requirements stated under the EU directives.

4. Establish a monitoring system.

5. Establish an accident reporting system

6. Issue a Declaration of Conformity

7. Save the documentation

8. Register with the appropriate authorities in Europe

#CE Marking #CE Marking Certification

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theinvinciblenoob · 6 years ago

Link

But it also asked the company to clarify the risk of unwanted pregnancies in instructions for the app.

Nor does the app offer any protection against STDs — unless users combine it with additional barrier methods of contraception.

The assessment by the Swedish MPA looks to have reached similar conclusions about certain aspects of the claims Natural Cycles’ has been making for the app.

via TechCrunch

#IFTTT #TechCrunch

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