#MDD to MDR Transition

[izielhealthcare]

MDD to MDR Transition

Why is the modification in the regulation (MDD to MDR Transition) adapted?

History: You may be aware of the breast implant scandal in France wherein instead of medical grade Silicon, a low-quality Silicon was used as a raw material for breast implants which got ruptured and there were several complaints filed which led to the recall of the device by the manufacturer.

Because of these kinds of incidents, the MODIFICATION to MDD came into the picture and it’s called MDR, which is more comprehensive and detailed than MDD.

How do we adapt to MDR?

·         Gap analysis while considering additional requirements of MDR.

·         Refer Annexure XVII of MDR

MDR focuses on the safety and performance assurance of the devices placed on the market. MDR assures that the product causes no harm to the customers. Clinical and Non-Clinical testing methods include Clinical Investigation, PMCF studies, Literature Searches Screening and Appraisal, bench tests, in-vitro tests, biocompatibility testing, and product-specific performance Tests (if any) are utilized to establish clinical evidence for demonstrating the safety and performance of the device. The Manufacturing facility audits are conducted as per ISO 13485 to comply with Cleanroom requirements and applicable standards. Corrective and Preventive Actions (CAPA) needed to be taken depending upon the severity of complaints generated through Field Safety Notices/Field Safety Corrective Actions. The IFUs and electronic IFUs are to be supplied by the manufacturer. Product retractability with UDI implementation has become a must for troubleshooting and the appropriate diagnosis of the complaint or defect related to the product.

Let us identify the requirements in MDD to MDR transition.

·         The major changes to be adapted in MDR.

·         MD Classification

·         Clinical Data Sources

·         Risk Management

·         Process Validation

·         Software Validation

·         GSPR checklist

·         Product Retraceability

 Major Inclusions in MDR

·         PRRC

·         SRN for Economic Operators

·         Annexure XVI includes products without an intended medical purpose like            contact lenses, brain stimulators, cosmetic products, etc.

·         Active Implantable Medical Devices

·         Sterilization

·         EN ISO 13485 and MDSAP Requirements

·         Conformity Assessment Routes

·         EUDAMED, UDI and Labelling

·         Technical Documentation

·         Clinical Evaluation

·         Clinical Investigation and PMCF

·         Reporting of serious incidents or failures to member states and trend reporting

·         IFU and eIFU Requirements

·         Cybersecurity

·         SSCP linked to EUDAMED open to all end-users (including a layman)

·         GSPR

 We at IZiel Healthcare have a long-standing collaboration with Obelis, a Belgium-based (European Authorized Representatives) to provide a “One-Stop Solution” to fully support Class I, IIa, IIb & III medical device manufacturers across USA, Europe & Asia. This collaboration would ensure to obtain conformity with the MDR (2017/745) requirements and maintain the CE Marking of global medical devices through technical support, consultancy, representation, and device registration services.

[omcmedicalblogs]

LEGACY MEDICAL DEVICES REQUIREMENTS IN EUROPE

Legacy medical devices include all previously regulated devices under the Medical Devices Directives (MDD 93/42/EEC 90/385/EEC) and In-vitro Diagnostic Devices Directive (IVDD 98/79/EC).

Medical Device Coordination Group (MDCG) published the guidance documents on the Application of EU MDR to legacy devices and Legacy device management for Legacy devices.

There are three terminologies to guide the manufacturers – old devices, legacy devices and MDR devices.

‘Old devices’ were placed on the market before 26 May 2021, holding valid Medical Device Directive Certificates or the AIMDD certificates.

‘Legacy Devices’ are those devices that have a valid CE certificate under the directives MDD and IVDD that were placed after 26 May 2021 or those that require a conformity assessment to be carried out.

A Class III device, for example, can be considered a legacy device because of the conformity tests done and valid CE certificates. Class Is / Im devices with self-declared certificates do not fall under this category.

Legacy devices must be MDR compliant under the prescribed transitional timelines set by the MDR (2017/745). The transitional provisions and timelines can be found in Article 120 of the EU MDR.

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This topic focuses on the Legacy Devices requirements per MDR 2017/745. EU MDR aims to implement the following aspects of medical devices:

Identification- This is achieved by Unique Device Identifiers (UDI).

Transparency- The Database available in EUDAMED (European Databank on Medical Devices.) ensures that the device description and details of different economic operators are open and easily accessible for users.

Surveillance-Post-Market Surveillance, vigilance reporting and Periodic Safety Update Reports (PSUR) are prime importance under MDR.

Identification of Legacy Medical Devices

To ensure proper identification of medical devices, UDI is implemented under MDR. Read more about UDI in our article on UDI (Unique Device Identification) system. For legacy devices, the identification is made possible with the help of EUDAMED-DI.

Some manufacturers may have implemented UDI to their medical devices. In such cases, the device identifier is obtained from the UDI-DI. Devices that do not have UDI should have a EUDAMED-DI designated by the manufacturer.

The European Commission document on the Management of legacy devices can be used to understand the different device identifiers.

Application of Post Market Requirements to Legacy Devices

All relevant requirements mentioned in MDR apply to legacy devices as well. This includes post-market surveillance, market surveillance and vigilance.

Manufacturers need to keep in mind the information required under Article 83 and Chapter VII of EU MDR while implementing a post-market surveillance system.

The Notified bodies must consider the new requirements applicable to manufacturers resulting from the transitional provisions as part of the surveillance framework.

Application of other MDR requirements to legacy devices

Application of all other requirements should be implemented to contribute to post-market surveillance, market surveillance, vigilance, and registration of economic operators and devices. This ensures an all-rounded and well-functioning surveillance system.

The other MDR requirements applicable to legacy devices are as follows.

Article 10(12-15)

Obligations of manufacturers for market surveillance, field safety notices and vigilance.

Article 11 (3) (c-g) and 11 (7)

Obligations of Authorised representatives.

Article 13 (2,4,5,6,10)

Importer obligations for IFU, labelling, and register of complaints.

Article 14 (2,4,6)

Distributor obligations.

Article 22

Article on system and procedure packs.

Article 29

Article of registration of medical devices and UDI.

Article 31

Article of registration of manufacturers, authorized representatives, and importers.

Article 83-100

Articles 83-88 on PMS, PSUR, vigilance, serious incident reporting, field safety corrections, and trend reporting.

Articles 89-99 on analysis of data, implementing acts, market surveillance activities, electronic system on market surveillance and others.

Articles 98-100 on Preventive health protection measures, Good administrative practice, and electronic system for market surveillance.

Get detailed information here: https://omcmedical.com/legacy-medical-devices-requirements-in-europe/

[iziel-healthcare]

MDD to MDR Transition for Medical Device

The transition from MDD to MDR is a crucial process for medical device manufacturers.

It requires careful planning and execution to ensure compliance with the new regulations.

CE Certification is mandatory for medical devices in Europe and is governed by the MDR.

It is essential for manufacturers to understand the requirements and make necessary changes.

Importance of MDD to MDR Transition

The MDR introduces stricter regulations and requirements for medical devices.

Manufacturers need to conduct a thorough MDD to MDR Gap Analysis to identify areas of non-compliance.

MDR Consultants can provide valuable guidance and support throughout the transition       process.

Steps in the Transition Process

Conduct a comprehensive review of existing processes and documentation.

Identify gaps and areas for improvement to meet MDR requirements.

Develop a detailed transition plan with clear timelines and responsibilities.

Ensure all stakeholders are informed and involved in the process.

Challenges in the Transition

Lack of understanding of MDR requirements and implications

Limited resources and expertise to implement necessary changes.

Time constraints and pressure to meet deadlines for transition.

Resistance to change within the organization.

 Conclusion

The MDD to MDR transition is a complex process that requires careful planning and execution.

Manufacturers must proactively address challenges and seek support from MDR    Consultants

Compliance with the MDR is essential for continued market access in Europe and ensuring patient safety.

[marketsandmarkets-events]

Challenges and Opportunities in Europe's Medical Device Regulatory Landscape

The regulatory landscape governing medical devices and diagnostics in Europe is a complex yet crucial framework designed to ensure the safety, efficacy, and quality of products entering the market. This article provides an in-depth exploration of the European regulatory environment for medical devices and diagnostics, highlighting key aspects, recent developments, and the implications for manufacturers, healthcare providers, and patients alike.

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Regulatory Framework Overview

In Europe, medical devices and in vitro diagnostic (IVD) devices are regulated under separate but interconnected regulatory frameworks: the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR). These regulations establish stringent requirements that manufacturers must adhere to before placing their products on the market.

Medical Devices Regulation (MDR):

The MDR, fully applicable since May 2021, replaced the previous Medical Devices Directive (MDD) and introduces more stringent requirements for market access.

It classifies devices into risk-based categories (Class I, IIa, IIb, and III) based on potential risks associated with their use.

Manufacturers must demonstrate compliance with essential requirements, including clinical evaluation, risk management, and post-market surveillance.

In Vitro Diagnostic Medical Devices Regulation (IVDR):

The IVDR, applicable from May 2022, similarly enhances regulatory scrutiny for IVDs compared to the previous In Vitro Diagnostic Devices Directive (IVDD).

It introduces stricter requirements for performance evaluation, clinical evidence, and post-market surveillance to ensure the accuracy and reliability of diagnostic tests.

Key Regulatory Requirements

Both regulations emphasize a lifecycle approach to device regulation, encompassing pre-market assessment, conformity assessment, and post-market surveillance. Key requirements include:

Clinical Evaluation and Performance Studies: Manufacturers must conduct comprehensive clinical evaluations or performance studies to demonstrate the safety and performance of their devices.

Quality Management Systems: Compliance with ISO 13485:2016, a harmonized standard for quality management systems specific to medical devices, is mandatory.

Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF): Continuous monitoring of devices on the market to identify and assess any potential risks or issues is required. This includes reporting adverse events and implementing corrective actions.

Unique Device Identification (UDI): Devices must be labeled with a UDI to enable traceability throughout the supply chain and facilitate post-market monitoring.

Implications for Stakeholders

The European regulatory framework impacts various stakeholders across the healthcare continuum:

Manufacturers: Companies must invest in rigorous clinical studies and compliance measures to meet regulatory requirements, potentially leading to increased time and cost for product development and market entry.

Healthcare Providers: Enhanced regulatory scrutiny aims to improve the reliability and safety of medical devices and diagnostics available to healthcare professionals, thereby enhancing patient outcomes.

Patients: Stricter regulations are designed to provide patients with access to safer and more effective medical devices and diagnostic tests, ensuring their health and well-being are prioritized.

Recent Developments and Challenges

The implementation of MDR and IVDR has faced several challenges, including:

Transition Period: Manufacturers and notified bodies have had to navigate a challenging transition from previous directives to the new regulations, requiring adaptations in processes and documentation.

Notified Body Capacity: There has been a strain on notified bodies responsible for assessing conformity of devices, leading to delays in certification and market entry for some products.

Global Harmonization: Efforts are ongoing to align European regulations with international standards and practices, facilitating global market access for manufacturers.

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The European regulatory framework for medical devices and diagnostics represents a significant milestone in ensuring patient safety and product quality. While the transition to MDR and IVDR has presented challenges, it also reflects a commitment to advancing healthcare through robust regulatory oversight. Stakeholders must continue to adapt to these evolving regulations, leveraging opportunities for innovation while prioritizing safety and efficacy in medical device and diagnostic developments.

Navigating the European regulatory landscape requires a thorough understanding of MDR and IVDR requirements, proactive compliance strategies, and a commitment to continuous improvement in medical device and diagnostic technologies.

[polarflying]

Propresenter 6 won't open

But the main text of the standard remained unchanged. The standard's foreword also was changed. A section for comments in the matrix comments on the comparabilities. In the current annexes ZA, ZB and ZC of the standard (then as edition EN ISO 13485-12) the requirements of the different annexes (such as II, V.) of the EU-Directives are opposed to the standard's content in a sort of matrix. But there are some points in the Directives which are not covered even when applying EN ISO 13485. This standard is based on EN ISO 9001 but is tailored specifically to the needs of manufacturers of medical devices and often constitutes the basis for proving compliance with the European requirements. Many manufacturers of medical devices are certified according to EN ISO 13485 as basis for their management system for the development and production of medical devices. In order to adjust to the current EU-Directives (90/385/EEC, 93/42/EEC and 98/79/EC) for medical devices EN ISO 13485 will be revised. As one of the leading notified bodies for CE marking, we can support you on selecting the most efficient conformity assessment routes to achieve CE marking.īSI ISO 13485 Certification is one component of the comprehensive portfolio of quality management assurance services that we provide. ISO 13485 is the quality management system standard accepted as the basis for CE marking medical devices under European Directives and Regulations.Īlthough ISO 13485 certification is not a direct requirement for CE marking medical devices under the European Medical Device Directives and Regulations, it is recognized as a harmonized standard by the European Commission. ISO 13485 is the best internationally-accepted model a medical device organization can implement to help demonstrate compliance to laws and regulations of the medical device industry. ISO 13485, CMDR, FDA and CE marking services from a notified body

Meet regulatory requirements and customer expectations.

Demonstrate that you produce safer and more effective medical devices.

Increase efficiency, cut costs and monitor supply chain performance.

Outline how to review and improve processes across your organization.

Increase access to more markets worldwide with certification.

Companies with this certification communicate a commitment to quality to both customers and regulators. Whether you are looking to operate internationally or expand locally, ISO 13485 Certification can help you improve overall performance, eliminate uncertainty, and widen market opportunities. What are the benefits of being certified to ISO 13485? Find out more about MDR transition and IVDR transition. The harmonization of EN ISO 13485:2016 is another step towards compliance to the recently published Medical Devices and IVD Regulations, which will supersede the current Directives in 20, respectively. Standard harmonization allows manufacturers to use their compliance to the standard as evidence of conformity to the requirements of relevant legislation. EN ISO 13485:2016 now replaces the previous version of the standard, EN ISO 13485:2012, in the EU Official Journal, with the date of ‘cessation of presumption of conformity’ of EN ISO 13485:2012 stated as 31 March 2019. ISO 13485:2016, the Medical Device Quality Management System standard, has been harmonized to the European Medical Devices Directives: MDD, AIMDD and IVDD. ISO 13485:2016 – The harmonized standard is here It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.

ISO 13485 was written to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. It is more prescriptive in nature and requires a more thoroughly documented quality management system. While ISO 13485 is based on the ISO 9001 process model concepts of Plan, Do, Check, Act, it is designed for regulatory compliance. ISO 13485 adapts the ISO 9000 process-based model for a regulated medical device manufacturing environment. ISO 13485 is a stand-alone QMS standard, derived from the internationally recognized and accepted ISO 9000 quality management standard series. What is an ISO 13485 Quality Management System? Adopting ISO 13485 provides a practical foundation for manufacturers to address the Medical Device Directives, regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices. Quality Management System (QMS) ISO 13485 Certification The ISO 13485 standard is an effective solution to meet the comprehensive requirements for a QMS.

[meeraoperon]

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 – enquiry@operonstrategist.com

[emson9624]

Regulatory Training - The new European Union Medical Device Regulation (MDR 2017/745) brings significant changes to previous regulations. The EU adopted the new Medical Device Regulation, replacing the two existing directives, the Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive. Device manufacturers who market products in the EU must be ready to meet the May 26, 2021 transition deadline (delayed from 2020 due to the coronavirus pandemic).  https://omcmedical.com/services/

[mdrconsultants]

Strategic planning of medical device.

The rapidly changing and complex regulatory environment in the global medical devices industry has resulted in the need for organizations to strengthen their safety and risk management practices in MDR transition training and improve their core set of expertise, all while reducing their operating model costs. Traditional operating models are being pushed to the point of breaking because of cost pressures, emerging competition, governmental and political demands and the weight of supporting global distribution channels. Not knowing what we don’t know, managing the complexity of the process, lack of specialists and resources and the ability to manage spikes are key issues medical device companies are facing from development to post-marketing monitoring.

From Medical Device Strategy Consulting and regulatory oversight to managing regulatory processes and preparing submissions, our global experience across all device types helps pave our path to market success. The investment in building cutting edge expertise and delivery models and services which complement our medical device client’s needs. We specialize in scientific knowledge-based processes and provide end-to-end services in a cost-effective manner. Our flexible approach also allows us to pick and choose activities within our service portfolio. By offering an integrated product delivery solution approach and leveraging our domain, process and technology expertise, we help our customers:

·         Ensure that they meet the ever-changing global regulatory landscape and achieve 100% compliance

·         Integrate clinical and commercial strategies to prove unique value

·         Balance resourcing as our portfolio adjusts to pipeline, regulatory and market fluctuations

·         Lower risk and maximize value in MDD to MDR transition training course during product commercialization

·         Reveal our product’s value to regulators, payers, providers and patients

·         Make “go/no go” decisions through the entire product lifecycle

For more details on this, please browse www.mdrconsultants.com.

[soniyawilson]

This allows MDR to offer a regulation that is consistent and fair to all member states, improving the standards on safety and quality measures. But for those who are confused with the changes, there is MDD To MDR Transition Training Course. The course provides details of the new MDR that is replacing the existing MDD and AIMDD.

[ddiclinical]

Medical Device Regulatory & Clinical Experts for new EU Medical Device Regulation. Our Experts guide your teams for a smooth transition from MDD to MDR & stay compliant. Learn more about our timely solutions today.

[operonstrategist-blog]

EU MDR Transition extension part 1

Let's learn about the MDR Transition Extension and its significance in this brief. . Let’s Connect! 🤩🤩 🤝

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[izielhealthcare]

Transitioning from MDD to MDR: Navigating the Evolution of Medical Device Regulation

In the dynamic landscape of healthcare, the regulatory environment governing medical devices is undergoing a transformative shift. The transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) marks a significant milestone, bringing about changes in requirements, compliance, and the overall regulatory framework. This blog aims to provide insights into the key aspects of transitioning from MDD to MDR, guiding manufacturers through this pivotal phase.

Understanding the Transition:

The Medical Device Regulation (MDR), adopted in 2017 and fully applicable since May 26, 2021, replaces the previous Medical Device Directive (MDD) and the Active Implantable Medical Devices Directive (AIMDD). This transition is designed to enhance the safety and performance of medical devices while addressing technological advancements and aligning with global regulatory trends.

Key Changes and Impacts:

1. Expanded Scope:

   - MDR expands the scope of regulated medical devices to include certain products that were previously not covered under MDD.

   - Manufacturers need to reassess their product classifications and ensure compliance with the new criteria.

2. Stricter Clinical Evidence Requirements:

   - MDR emphasizes the importance of robust clinical evidence to support the safety and performance of medical devices.

   - Manufacturers must conduct thorough clinical evaluations and update their documentation accordingly.

3. Unique Device Identification (UDI):

   - Introduction of a UDI system is a significant change, requiring each device to bear a unique identifier for traceability throughout its lifecycle.

   - Manufacturers need to implement UDI labeling and data management systems.

4. Economic Operators and Supply Chain Responsibilities:

   - MDR introduces new roles, including Importers and Distributors, each with defined responsibilities in ensuring compliance and reporting adverse events.

   - Manufacturers must establish clear agreements and communication channels within the supply chain.

5. Post-Market Surveillance (PMS) and Vigilance:

   - Enhanced post-market surveillance requirements necessitate proactive monitoring of device performance in real-world settings.

   - Vigilance reporting obligations are expanded, requiring timely reporting of incidents to competent authorities.

6. Conformity Assessment Procedures:

   - MDR introduces more rigorous conformity assessment procedures, particularly for high-risk devices.

   - Manufacturers should engage with Notified Bodies early in the development process to ensure a smooth transition.

Challenges in the Transition:

1. Resource Intensity:

   - The transition process demands significant resources, including time, expertise, and financial investments.

   - Manufacturers must allocate resources efficiently to meet the stringent MDR requirements.

2. Limited Notified Body Capacity:

   - The limited capacity of Notified Bodies for MDR certification has created challenges in scheduling assessments.

   - Manufacturers need to plan well in advance and engage with Notified Bodies promptly.

3. Data Collection and Management:

   - Meeting the heightened clinical evidence requirements may pose challenges in terms of data collection and management.

   - A comprehensive strategy for clinical evaluations and post-market surveillance is essential.

The transition from MDD to MDR represents a paradigm shift in the regulatory landscape for medical devices. Manufacturers must proactively adapt to the changes, invest in compliance measures, and collaborate closely with regulatory authorities and Notified Bodies. By embracing these challenges as opportunities for improvement, the industry can ensure the continued delivery of safe and effective medical devices, meeting the evolving needs of healthcare and enhancing patient safety across the European market.

[operonstrategist98]

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.

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

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).

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/

[iziel-healthcare]

MDD to MDR Transition for Medical Device

The transition from MDD to MDR is a crucial process for medical device manufacturers.

It requires careful planning and execution to ensure compliance with the new regulations.

CE Certification is mandatory for medical devices in Europe and is governed by the MDR.

It is essential for manufacturers to understand the requirements and make necessary changes.

Importance of MDD to MDR Transition

The MDR introduces stricter regulations and requirements for medical devices.

Manufacturers need to conduct a thorough MDD to MDR Gap Analysis to identify areas of non-compliance.

MDR Consultants can provide valuable guidance and support throughout the transition process.

Steps in the Transition Process

Conduct a comprehensive review of existing processes and documentation.

Identify gaps and areas for improvement to meet MDR requirements.

Develop a detailed transition plan with clear timelines and responsibilities.

Ensure all stakeholders are informed and involved in the process.

Challenges in the Transition

Lack of understanding of MDR requirements and implications

Limited resources and expertise to implement necessary changes.

Time constraints and pressure to meet deadlines for transition.

Resistance to change within the organization.

Conclusion

· The MDD to MDR transition is a complex process that requires careful planning and execution.

· Manufacturers must proactively address challenges and seek support from MDR Consultants

· Compliance with the MDR is essential for continued market access in Europe and ensuring patient safety.

[meeraoperon]

EU MDR compliance for Legacy Devices

EU MDR compliance for Legacy Devices

Legacy devices are the medical devices, active implantable medical devices and in vitro diagnostic devices that are placed in the market with valid certificates issued from Medical Devices Directive (MDD) or Active Implantable Medical Device (AIMD). The valid CE (Conformité Européenne) marking certificates are issued according to Directive 93/42/EEC, Directive 90/85/EEC or Directive 98/97/EC on medical devices. The legacy devices continue to be in market when it meets EU MDR compliance for legacy devices as per set timelines.REGISTRATION OF LEGACY DEVICESA document “MDCG 2019-5 “Registration of legacy devices in EUDAMED April 2019” explains the guidance on registration of legacy devices in EUDAMED.  EUDAMED is the European Database for Medical Devices.  According to new guidelines the legacy devices are registered in EUDAMED. The registration of legacy devices is mandatory when there is a serious incident related to the product or there is any field corrective action necessary towards it.A NEW GUIDANCE ON EU MDR COMPLIANCE FOR LEGACY MEDICAL DEVICESThe European Commission’s Medical Device Coordination Group (MDCG) ‘s has put forth a new guidance that describes the implementation and application of MDR requirements for legacy devices and the devices placed in the market before 26 may 2021. The MDGC had set up ad hoc task- force for applying transitional provisions to the legacy devices and devices placed in the market before 26 may 2021 mentioned in Article 120(3) of Regulation (EU) 2017/745 (MDR)Read More  -   EU MDR compliance for Legacy Devices Read More Article - 1. Orthopedic Implants Manufacturing 2. disposable syringe manufacturers 3. Dental Implants Manufacturing 4.Blood Collection Tubes Manufacturing Contact details – Phone  no -  93702 83428Mail id – enquiry@operonstrategist.com