#MDD to MDR

[izielhealthcare]

What are the key MDR changes?

Until today, medical devices were complying with the Medical Device Directive to sell their products in Europe. However major amendments are made in the current MDD to keep up with the growing technological advances in healthcare and medical devices.

Typically, all MDD-MDR transition projects initiate with Gap Assessment. Gap Assessment is a crucial activity during MDR transition & our team with engineering & regulatory expertise are well equipped to conduct this activity with an analytical mindset, resolve any regulatory concern and develop robust regulatory strategy for medical device manufacturers.

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

[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.

[mariacarey544]

Deciphering Medical Device Registration in the EU: A Comprehensive Handbook 

Navigating the regulatory maze of medical devices within the European Union (EU) can be daunting, particularly concerning registration. This comprehensive guide aims to empower manufacturers with the requisite knowledge to effectively navigate the Medical Device Registration EU process, ensuring compliance with the Medical Devices Regulation (MDR) and instilling confidence in bringing their medical devices to the European market. 

The Evolving Regulatory Landscape  

The Medical Device Regulation (MDR) (Regulation (EU) 2017/745) fully replaced the previous Medical Devices Directive (MDD) in May 2021. The MDR introduces more stringent requirements than its predecessor, with the objective of enhancing the safety, quality, and transparency of medical devices available in the EU. 

Key Aspects of Medical Device Registration Classification:  

The initial step entails classifying your device based on its intended purpose and inherent risks. The MDR outlines four risk classes, ranging from Class I (Lowest Risk) to Class III (Highest Risk), each dictating specific conformity assessment routes required for CE marking, which is mandatory for placing medical devices on the EU market. 

Unique Device Identification (UDI): All medical devices in the EU must be equipped with a Unique Device Identification (UDI) system, facilitating efficient traceability, vigilance, and market surveillance. Manufacturers must assign UDIs to their devices and submit them to the European Database on Medical Devices (EUDAMED). 

EUDAMED Registration: EUDAMED serves as a centralized repository for information on all medical devices and stakeholders involved in the EU supply chain. Manufacturers are obligated to register themselves and their devices on EUDAMED, providing comprehensive details such as device information, technical documentation, and contact details of the Person Responsible for Regulatory Compliance (PRRC). 

Conformity Assessment Procedures: The conformity assessment procedure applicable to your device is contingent upon its risk class. Lower-risk devices (Class I and IIa) typically involve fewer complex procedures, while higher-risk devices (Class IIb and III) necessitate involvement from a Notified Body, independent organizations designated by the EU to assess compliance with MDR requirements. Conformity assessment procedures may involve internal production control system audits, technical documentation review, and clinical investigation and evaluation by a Notified Body. 

Additional Considerations  

To ensure safety and functionality, medical devices undergo conformance evaluation by the European Union (EU), with involvement from the European Medicines Agency (EMA). Additionally, medical devices are regulated at the EU Member States level. 

Technical Documentation: Manufacturers must compile comprehensive technical documentation demonstrating their device's adherence to MDR requirements, serving as the basis for conformity assessment by Notified Bodies. 

Person Responsible for Regulatory Compliance (PRRC): It is mandatory to appoint a PRRC within the EU, responsible for ensuring MDR compliance throughout the device's lifecycle, including post-market surveillance activities. 

Post-Market Surveillance: Manufacturers have ongoing obligations to monitor their devices after-market launch, including reporting serious adverse events and incidents to relevant authorities and implementing Corrective and Preventive Actions (CAPA) to address identified risks or non-conformities. 

Seeking Expert Guidance: Given the intricacies involved, it is highly recommended for manufacturers to seek guidance from qualified regulatory consultants or legal professionals specializing in EU CE Marking medical device regulations. They can provide invaluable assistance in navigating the registration process, ensuring compliance with MDR requirements, and facilitating successful market entry in the EU. 

Overview of the Medical Device Registration Process 

Stage 

Description 

Classification 

Categorize device based on risk (Class I-III) 

Unique Device Identification (UDI) 

Assign unique identifier for traceability 

EUDAMED Registration 

Register device and details in EUDAMED database 

Conformity Assessment 

Follow procedures based on class (internal audit, notified body review, etc.) 

Additional Considerations 

Technical documentation, Person Responsible for Regulatory Compliance (PRRC), Post-Market Surveillance (reporting incidents, CAPA) 

Table 1: Overview of the Medical Device Registration Process 

Conclusion 

Comprehending and adhering to the medical device registration EU process is imperative for manufacturers seeking to introduce their products to the European market. By complying with MDR requirements and leveraging expert guidance, when necessary, manufacturers can ensure patient safety, regulatory compliance, and a prosperous market presence within the EU. 

[omcmedicalblog]

What You Need to Know About Medical Device Regulation in Europe

Introduction about Medical Device Regulation in Europe

Introducing the Medical Device Regulation in Europe addresses several challenges. It aims to enhance medical device regulation in Europe to ensure a higher level of safety and effectiveness. The need for the MDR arises from various factors, including shortcomings identified in the previous regulatory framework (Medical Device Directives) and the evolving landscape of medical technologies.

Rapid technological advancements in the field of medical devices have led to the development of increasingly complex and innovative products. The MDR adapts the regulatory framework to account for these technological advancements and to ensure the safety and performance of new and emerging devices.

The primary objective of the MDR is to prioritize patient safety. By introducing more stringent requirements for conformity assessment, clinical evidence, and post-market surveillance, the regulation aims to reduce the risk of harm to patients and users of medical devices. The MDR promotes transparency by introducing measures such as the European Database on Medical Devices (EUDAMED).

This database allows better traceability of medical devices in the market and facilitates communication between regulatory authorities, manufacturers, and other stakeholders. The MDR places a greater emphasis on post-market surveillance activities, ensuring that medical devices are continually monitored once they are on the market.

This enables timely identification and response to safety issues and improves overall device performance.

The MDR aims to harmonize the regulatory requirements for medical devices across EU member states. This harmonization facilitates a more consistent and predictable regulatory environment for manufacturers, streamlining the process of bringing products to market.

The MDR introduces a more refined classification system for medical devices, taking into account the potential risks associated with devices. This allows for a more accurate categorization of devices based on their characteristics and intended use. The MDR clarifies the roles and responsibilities of economic operators, including manufacturers, authorized representatives, importers, and distributors.

This enhances accountability throughout the supply chain, ensuring that each party plays a defined role in ensuring device compliance and safety.

The MDR aligns with global best practices and standards, contributing to international regulatory convergence. This alignment is essential for manufacturers who intend to market their devices globally. The MDR addresses identified gaps and weaknesses in the previous regulatory framework, the Medical Device Directives (MDD).

These gaps included challenges related to the classification of devices, insufficient requirements for clinical evidence, and variations in the interpretation and application of the directives among member states.

Medical Device Compliance

Medical device compliance refers to the adherence of medical devices to regulatory standards and requirements set by relevant authorities. Ensuring compliance is crucial to guarantee the safety, efficacy, and quality of medical devices, protecting both patients and healthcare providers.

The key aspects of medical device compliance are:

Regulatory Authorities

Different countries have regulatory bodies responsible for overseeing medical devices. For example, the U.S. FDA in the US, the European Medicines Agency (EMA) in the EU, and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. Manufacturers must comply with the regulations specific to the regions where they intend to market their devices.

Classification of Devices

Medical devices are often categorized based on their risk level. The risk classifications include Class I, IIa, IIb, and III in the European Union under the MDR.

Quality Management Systems (QMS)

Compliance often involves the implementation of a QMS, such as ISO 13485. This ensures that manufacturers establish and maintain processes to consistently produce safe and effective medical devices.

Pre-market Approval (PMA) or Conformité Européenne (CE) Marking

Before marketing a medical device, manufacturers may need to obtain regulatory approval or clearance. In the U.S., this may involve the submission of a PMA application, while in the EU, devices need to be CE marked according to applicable regulations.

Post-market Surveillance

Manufacturers are required to monitor and report adverse events and product issues after a device is on the market. This involves maintaining a system for post-market surveillance and reporting to regulatory authorities.

Labelling and Instructions for Use

Compliance includes providing accurate and clear labelling for medical devices. Instructions for use must be easily understandable, and information about potential risks and proper usage should be prominently displayed.

Risk Management

Manufacturers must conduct risk assessments for their devices to identify and mitigate potential risks throughout the product lifecycle.

Clinical Data and Performance

Submission of relevant clinical data is often required for regulatory approval. This data supports claims regarding the safety and performance of the medical device.

Adherence to Standards

Compliance with relevant industry standards, such as those developed by the International Electrotechnical Commission (IEC) or ASTM International, is often necessary to demonstrate that a device meets specific criteria.

Audits and Inspections

Regulatory authorities may conduct audits and inspections to ensure that manufacturers are complying with all applicable regulations.

EU Medical Device Directive

The Medical Devices Directive (93/42/EEC) was one of the main directives governing the marketing and distribution of medical devices within the European Union. It provided the regulatory framework for the safety and performance of medical devices and outlined essential requirements that devices needed to meet.

The MDR (2017/745) came into effect in May 2021, replacing the Medical Devices Directive. It introduced more stringent requirements for the approval and surveillance of medical devices in the European Union.

The MDR emphasizes increased transparency, traceability, and the involvement of notified bodies in the conformity assessment process.

The MDR came into force on May 26, 2017, but the date of application was postponed several times. As of my last update, it was set to be fully applicable from May 26, 2021.

Key Changes and Features:

Stricter Scrutiny: The MDR introduces more rigorous pre-market assessment procedures, including enhanced scrutiny of high-risk devices.

Unique Device Identification (UDI): It mandates the use of a UDI system for better traceability of devices throughout their lifecycle.

EUDAMED Database: The establishment of the European Database on Medical Devices (EUDAMED) for the registration and dissemination of information about medical devices.

Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF): Strengthened requirements for post-market surveillance and clinical follow-up to monitor and report on device performance.

According to the MDR 2017/745, a ‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:

diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,

diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,

investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,

providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations.

 Medical Device Certification in Europe

The CE marking is a certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area (EEA). The CE marking is mandatory for various product categories, including medical devices.

For medical devices, obtaining the CE marking signifies compliance with the applicable European regulations, such as the Medical Device Regulation (MDR) or the In Vitro Diagnostic Regulation (IVDR).

The CE marking demonstrates that a product meets the essential requirements outlined in European Union (EU) directives or regulations, ensuring a high level of safety and performance. Medical devices that are intended to be placed on the market within the EEA must bear the CE marking.

This includes a wide range of products, from simple devices to complex technologies. The CE marking allows a medical device to be legally placed on the market and sold within the EEA. Various economic operators in the supply chain, including manufacturers, importers, distributors, and authorized representatives, have specific responsibilities related to the CE marking process.

As part of the new regulatory framework, information about medical devices, including their CE certificates, will be registered in the European Database on Medical Devices (EUDAMED).

Manufacturers must continuously ensure that their devices remain in compliance with regulatory requirements. This includes monitoring post-market surveillance data and promptly addressing any safety concerns.

Manufacturers of medical devices must follow a series of steps to affix the CE marking:

Conformity Assessment: The manufacturer assesses the device’s conformity with applicable EU regulations. This assessment can involve self-certification or the involvement of a Notified Body, depending on the device’s risk classification.

Technical Documentation: The manufacturer prepares comprehensive technical documentation that demonstrates compliance with essential requirements, including design, manufacturing, and performance data.

Quality Management System (QMS): Manufacturers must implement and maintain a QMS in accordance with relevant standards, such as ISO 13485.

Declaration of Conformity: Once the conformity assessment is successful, the manufacturer issues a Declaration of Conformity, declaring that the device meets the requirements of applicable EU regulations.

Affixing the CE Mark: The CE marking is affixed to the product, packaging, or accompanying documentation, indicating that the device complies with EU regulations.

 Europe healthcare device standards

European healthcare device standards are a set of technical specifications and criteria that provide a common language and framework for the design, manufacturing, and performance of healthcare devices within the European Union (EU).

These standards are developed by various standardization organizations, and compliance with these standards helps manufacturers meet regulatory requirements and ensure the safety and efficacy of their devices. Some of these standards are:

ISO Standards: cover various aspects, including quality management, risk management, and specific requirements for different types of medical devices.

Electromagnetic Compatibility (EMC) Standards: Healthcare devices, especially electronic and electrical equipment, must comply to ensure that they do not interfere with other devices and are not susceptible to interference. Common standards include EN 60601-1-2 for medical electrical equipment.

Biocompatibility Standards: ensure that materials used in devices do not cause adverse reactions when in contact with the human body. EN ISO 10993 is a series of standards addressing biocompatibility.

Quality Management System (QMS) Standards: Compliance with quality management system standards is essential for medical device manufacturers. ISO 13485 is an international standard, and compliance with it is often required for the CE marking of medical devices in Europe.

Risk Management Standards: Risk management is a critical aspect of medical device design and manufacturing. EN ISO 14971 is the standard that outlines the principles for risk management.

Sterilization Standards: standards like EN ISO 11135 for ethylene oxide sterilization and EN ISO 17665 for moist heat sterilization provide guidelines for ensuring the effectiveness of the sterilization process.

Software Standards: As software plays an increasingly important role in healthcare devices, standards like IEC 62304 provide guidance on the software life cycle processes.

Usability and Human Factors Standards: Standards in this category address the design and usability of healthcare devices to ensure that they are user-friendly and safe. EN ISO 14971 and IEC 62366 are relevant standards.

Labelling Standards: Standards related to labelling provide guidance on the information that should be included on medical device labels. EN 980 and EN ISO 15223-1 are examples.

It’s important for manufacturers and stakeholders in the healthcare industry to stay updated on the latest standards and ensure compliance with relevant regulations, as these standards play a crucial role in demonstrating conformity to essential requirements for medical devices in the European market.

Additionally, the specific standards applicable to a particular device depend on its type, classification, and intended use.

Conclusion

In conclusion, the unveiling of the Medical Device Regulation in Europe represents a significant milestone in the evolution of regulatory standards for Medical Device Regulation in Europe. The comprehensive changes introduced by the MDR are driven by a commitment to advancing patient safety, fostering innovation, and adapting to the rapidly evolving landscape of healthcare technologies.

The MDR addresses critical shortcomings identified in the previous regulatory framework, offering a more robust and transparent system for the approval and surveillance of medical devices.

With a heightened focus on risk management, clinical evidence, and post-market surveillance, the MDR aims to ensure that medical devices entering the European market meet the highest standards of safety and efficacy.

Key elements of the MDR include an enhanced classification system, stricter conformity assessment procedures, and the implementation of a Unique Device Identification (UDI) system. These features contribute to a more sophisticated and nuanced approach to regulatory compliance, tailored to the diverse range of medical devices and their associated risks.

The regulation’s emphasis on transparency is evident in the establishment of the EUDAMED, providing stakeholders with a centralized platform for information sharing and increased traceability. This marks a crucial step towards creating a harmonized regulatory environment across EU member states.

As manufacturers navigate the complexities of compliance, understanding the requirements of the MDR becomes paramount. The alignment of the MDR with global standards fosters a seamless transition for manufacturers looking to market their devices internationally, reinforcing the EU’s commitment to global regulatory convergence.

In essence, the EU MDR sets a new benchmark for the medical device industry, demanding higher standards of quality, safety, and accountability. While the transition may present challenges for manufacturers, the long-term benefits lie in a safer and more innovative landscape that ultimately benefits patients and healthcare systems across Europe.

Staying informed about the intricacies of the MDR and collaborating with regulatory experts will be crucial for industry players aiming to navigate this transformative regulatory landscape successfully.

Originally Published at: https://omcmedical.com/things-about-medical-device-regulation-in-europe/

[5aiconsulting]

Understanding MDD and MDR Remediation Services in the UK

The Medical Device Directive (MDD) and Medical Device Regulation  (MDR) are the two administrative structures that oversee the planning, assembly, and circulation of clinical gadgets in the European Union (EU). These guidelines guarantee that clinical gadgets meet the most noteworthy security and quality norms before they are delivered into the market. Notwithstanding, consistency with these guidelines can be a difficult undertaking for clinical gadget makers, particularly those that are new to the business or have restricted assets.

In the UK, MDD and MDR remediation services have arisen as an answer to assist clinical gadget producers with following these guidelines. These services offer help and direction to decision-makers in each part of the administrative cycle, from surveying the effect of the new guidelines to carrying out new cycles and strategies.

MDD remediation services center around assisting producers with changing from the MDD to the MDR. The MDR has presented new prerequisites, like more severe clinical proof necessities, upgraded post-market reconnaissance commitments, and new naming and bundling necessities. MDD remediation services assist makers with evaluating their items against these new prerequisites and recognizing regions where they need to work on their cycles and documentation.

Then again, MDR remediation services center around assisting producers who have previously progressed to the MDR but are attempting to consent to its necessities. These services give a scope of help, for example, exploring specialized documentation, creating post-market reconnaissance plans, and assisting with naming and bundling consistency. The advantages of MDD and MDR remediation services for clinical gadget producers are various.

These services give access to a group of specialists who are knowledgeable in the administrative scene and can give direction on complex issues. Furthermore, producers can set aside time and cash by reevaluating their administrative consistency needs with an outside service provider. At last, by guaranteeing consistency with these guidelines, makers can upgrade their standing and increase market access.

All in all, MDD and MDR remediation services are fundamental for clinical gadget producers in the UK that need to stay on top of the most recent administrative necessities. By joining forces with a trusted service provider, makers can guarantee that their items meet the most noteworthy security and quality guidelines while likewise smoothing out their administrative consistency processes.

For More Info:-

MDD MDR Remediation Service UK

IVDR MDR Technical Files Writing Service

[siscert45]

ISO 13485 Certifications for Medical Device Standards - SIS Certifications

We offer ISO 13485 Certification for Medical device quality management systems. We are the best ISO Certification body in the world.

ISO 13485 Certification is the medical device industry’s most broadly utilized worldwide standard for the quality management system. Given by the International Organization for Standardization (ISO), the ISO 13485 Certification is a powerful answer for meeting the thorough prerequisites for a QMS in the medical device industry. Receiving ISO 13485 Certification gives a down-to-earth establishment to makers to address the EU Medical Device Directive (MDD), the EU Medical Device Regulation (MDR), and different guidelines, just as showing a promise to the security and quality of medical devices.

[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.

[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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[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.

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.

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?

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

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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.