The Role of Notified Bodies in Assessing Clinical Evaluation Reports (CERs) under EU MDR

The Role of Notified Bodies in Assessing Clinical Evaluation Reports (CERs) under EU MDR

Clinical evaluation is a continuous procedure that happens at every stage of a medical device’s life cycle. It is typically carried out initially in the course of developing a medical device to determine what data must be produced to gain access to the market.

The first CE-marking must include a clinical evaluation, and it must be regularly updated going forward.

Clinical evaluation is essential and significant because it guarantees that assessments of the device’s performance and safety are grounded on adequate clinical evidence on the market.

Through this continuous procedure, manufacturers can give notified bodies and appropriate authorities enough clinical evidence to show that the device complies with the Essential Requirements for its life.

To support the evidence of a product’s compliance with the Essential Requirements of the applicable Directive, medical device manufacturers produce clinical evaluation reports and accompanying documentation, which the notified body evaluates and verifies.

Appendix A12 (Activities of Notified Bodies) contains comprehensive suggestions for notified bodies. These consist of:

  • Advice for notified bodies regarding the evaluation of clinical assessment reports that manufacturers of medical devices supply as part of technical documentation (such as design dossiers); and
  • advice for notified bodies regarding the creation of internal protocols for the evaluation of clinical aspects associated with medical devices.

Furthermore, referring to the Notified Bodies Operations Group (NBOG) papers is recommended. Checklists, forms, and best practice recommendations are all included in NBOG documents.

Under the European Medical Device Regulation (MDR), notified bodies play a crucial role in assessing the conformity of medical devices before they can be placed on the market. The EU MDR (Medical Device Regulation) is a regulatory framework governing medical devices within the European Union.

It aims to ensure the safety and performance of such devices while enhancing transparency and traceability throughout the supply chain.

Notified bodies are organizations designated by EU member states and authorized by the European Commission to conduct conformity assessments of medical devices.

Their main responsibility is to evaluate whether medical devices meet the requirements set forth in the EU MDR and comply with relevant harmonized standards.

Role in Assessing Clinical Evaluation Reports (CERs) under the EU MDR

Here’s an overview of their role in assessing CERs under the EU MDR:

1. Reviewing Clinical Evaluation Reports (CERs)

Notified bodies are responsible for reviewing the Clinical Evaluation Reports submitted by medical device manufacturers. These reports are essential documents that demonstrate the safety and performance of the medical device based on clinical data and literature review.

Overall, notified bodies play a critical role in ensuring the quality, reliability, and compliance of Clinical Evaluation Reports under the EU MDR, thereby contributing to the safety and effectiveness of medical devices marketed within the European Union.

2. Assessing Compliance with Regulatory Requirements

Notified bodies assess whether the CERs comply with the requirements outlined in the EU MDR. This includes verifying that the clinical data presented in the CERs are relevant, valid, and sufficient to demonstrate the safety and performance of the medical device throughout its lifecycle.

3. Verification of Clinical Data

Notified bodies verify the integrity and reliability of the clinical data presented in the CERs. They assess whether the data sources used in the clinical evaluation are appropriate and whether the analysis and conclusions drawn from the data are scientifically sound.

4. Assessing clinical evidence

Notified bodies employ experts with the necessary clinical, scientific, and technical expertise to evaluate CERs effectively. These experts assess the clinical evidence presented in the reports to ensure it supports the medical device’s intended purpose and claims.

5. Post-Market Surveillance

Notified bodies also play a role in post-market surveillance activities related to clinical data. They may review post-market clinical follow-up data and reports to ensure ongoing compliance with regulatory requirements and to assess the continued safety and performance of the medical device.

6. Interaction with Competent Authorities

Notified bodies collaborate with competent authorities, such as national regulatory agencies, to ensure consistency in the assessment of CERs and to address any concerns or issues that may arise during the evaluation process.

7. Granting of CE Marking:

Based on their assessment of the CERs and other conformity assessment activities, notified bodies to determine whether a medical device meets the requirements for CE marking.

CE marking indicates that the device complies with the applicable regulatory requirements and can be placed on the market within the European Union.

Under the European Medical Device Regulation (EU MDR), notified bodies are designated organizations responsible for assessing the conformity of medical devices with regulatory requirements before they can be placed on the market or put into service within the European Union.

Several Criteria and Obligations of Notified Bodies

To meet the EU MDR requirements, notified bodies must adhere to several criteria and obligations.

1. Designation and Accreditation

Notified bodies must be designated by a Member State and accredited to conduct conformity assessments of medical devices according to the requirements of the EU MDR.

They must demonstrate compliance with ISO/IEC 17000 series standards for conformity assessment.

2. Technical Competence

Notified bodies must possess and maintain the necessary technical expertise and competence to assess the conformity of medical devices with the relevant requirements of the EU MDR.

This includes expertise in areas such as clinical evaluation, risk management, quality management systems, and regulatory affairs.

3. Independence and Impartiality

Notified bodies must operate independently and impartially, free from any undue influence that could affect the objectivity or integrity of their conformity assessment activities. They must establish and maintain procedures to manage conflicts of interest effectively.

4. Quality Management System

Notified bodies must have a quality management system (QMS) in place that meets the requirements of the EU MDR. This QMS should ensure the consistent and reliable performance of conformity assessment activities, including document control, personnel competence, and audit processes.

5. Assessment Procedures

Notified bodies must establish and maintain documented procedures for conducting conformity assessments of medical devices.

These procedures should outline the steps and criteria for evaluating devices’ conformity with applicable requirements, including clinical evaluation, technical documentation review, and quality management system assessment.

6. Competent Personnel

Notified bodies must employ personnel with the qualifications, expertise, and experience to perform their duties effectively. This includes experts in various relevant fields, such as clinical evaluation, regulatory affairs, biomedical engineering, and quality assurance.

7. Transparency and Communication

Notified bodies must ensure transparency in their operations and communicate effectively with manufacturers, authorities, and other stakeholders. They must provide transparent information about their processes, fees, timelines, and any decisions made regarding conformity assessment.

8. Monitoring and Surveillance

Notified bodies are subject to ongoing monitoring and surveillance by competent authorities to ensure compliance with the EU MDR requirements.

This includes regular audits, assessments, and inspections to verify the competence and performance of notified bodies in conducting conformity assessments.

By fulfilling these requirements, notified bodies play a crucial role in ensuring the safety, quality, and effectiveness of medical devices placed on the market within the European Union under the EU MDR regulatory framework.

EU MDR Unveiled: What You Need to Know About Medical Device Regulation in Europe

EU MDR Unveiled: 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 Medical Device Regulation in Europe 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 of Medical Device Regulation in Europe:

  • 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 Device Regulation in Europe.

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 Device Regulation in Europe 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:

  1. 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 Device Regulation in Europe 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.

Staying Vigilant: Best Practices for Post-Market Surveillance under EU MDR

Staying Vigilant: Best Practices for Post-Market Surveillance under EU MDR

As medical device manufacturers navigate the landscape of post-market surveillance (PMS) under the European Medical Device Regulation (EU MDR), maintaining vigilance and adherence to best practices is crucial. Effective PMS not only ensures ongoing product safety and efficacy but also facilitates compliance with regulatory requirements.

Top 7 Key Strategies for optimizing Post-Market Surveillance

Here, we outline key strategies for optimizing post-market surveillance in alignment with EU MDR standards.

1. Early Integration of Post-Market Surveillance into Quality Management

Integrate post-market surveillance activities into your quality management system (QMS) from the outset of product development. By incorporating PMS processes early, you establish a solid foundation for ongoing monitoring and compliance with EU MDR requirements.

This proactive approach mitigates risks and facilitates timely identification and resolution of issues in the post-market phase.

2. Implement Robust Post-Market Monitoring Protocols

Establish comprehensive post-market monitoring protocols to systematically collect, analyze, and respond to data related to device performance, adverse events, and customer feedback.

Regularly review and update these protocols to align with evolving regulatory guidelines and industry best practices. By conducting thorough post-market monitoring, you demonstrate a commitment to patient safety and regulatory compliance.

3. Leverage Purpose-Built Tools for PMS

Utilize specialized software solutions designed for medical device surveillance and post-market monitoring. These tools offer features such as complaint handling, nonconformance management, and CAPA processes tailored to EU MDR requirements.

By leveraging purpose-built tools, you streamline PMS workflows, enhance data accuracy, and ensure compliance with regulatory standards.

4. Foster Cross-Functional Collaboration

Promote cross-functional collaboration and communication across departments involved in post-market surveillance, including regulatory affairs, quality assurance, and product development.

Establish clear channels for reporting and escalating issues, facilitating timely decision-making and corrective actions. By fostering a collaborative culture, you enhance transparency and accountability in PMS activities.

5. Ensure Compliance with Post-Market Requirements

Stay informed and up-to-date on the latest post-market requirements outlined in EU MDR legislation. Regularly review guidance documents and regulatory updates issued by competent authorities to ensure compliance with reporting obligations, vigilance requirements, and post-market clinical follow-up (PMCF) obligations.

By maintaining compliance with post-market requirements, you mitigate regulatory risks and uphold patient safety standards.

6. Enhance Data Traceability and Documentation

Maintain comprehensive traceability of post-market surveillance activities through robust documentation and data management practices. Implement systems for documenting complaints, adverse events, corrective actions, and other PMS-related information in accordance with EU MDR documentation requirements.

By enhancing data traceability, you facilitate regulatory inspections and demonstrate compliance with post-market obligations.

7. Embrace Continuous Improvement

Embrace a culture of continuous improvement in post-market surveillance processes, leveraging data-driven insights to drive enhancements and optimizations.

Regularly assess the effectiveness of PMS activities, identify areas for improvement, and implement corrective measures as needed. By prioritizing continuous improvement, you demonstrate a commitment to excellence in post-market surveillance and patient safety.

In conclusion, staying vigilant in post-market surveillance under EU MDR requires proactive planning, robust monitoring protocols, and a commitment to compliance with regulatory requirements.

By integrating PMS into quality management systems, leveraging purpose-built tools, fostering cross-functional collaboration, and embracing continuous improvement, medical device manufacturers can navigate the complexities of post-market surveillance with confidence and ensure ongoing regulatory compliance.

Strategic Approach to Compliance: Mastering the Quality Management System (QMS) in EU MDR

Strategic Approach to Compliance: Mastering the Quality Management System (QMS) in EU MDR

QMS (Quality Management System) and ISO 13485

A Quality Management System is defined by ISO 13485 as a set of processes, procedures, and responsibilities for achieving quality policies and objectives in a medical device manufacturing organisation. It is a structured system that ensures that medical devices consistently meet customer and regulatory requirements.

ISO 13485 is an international standard that specifies requirements for a QMS specific to the medical device industry. ISO 13485 is a stand-alone QMS standard based on ISO 9001:2008, superseded by ISO 9001:2015.

It covers the design, development, production, storage, distribution, installation, servicing, and final decommissioning of medical devices.

Implementing a QMS based on ISO 13485 helps organisations demonstrate their ability to provide medical devices and related services that meet customer expectations and regulatory requirements, fostering customer confidence and regulatory compliance.

One of the critical advantages of ISO 13485 is that it ensures a strong starting point if a manufacturer wants to certify their products under the EU Medical Device Regulation and In Vitro Diagnostic Regulation (IVDR).

MDR requirements for QMS

EU MDR states the requirement for a well-established and maintained QMS in Article 10 (9).

Article 10 of the Medical Device Regulation (MDR) outlines a set of criteria governing Quality Management Systems (QMS) for Manufacturers operating in the medical device sector.

This article mandates that manufacturers establish, document, implement, maintain, update, and enhance a QMS that aligns with MDR specifications. Furthermore, it stipulates that the QMS must be aligned with the risk classification, the nature of the device and the business.

Article 10 specifies several fundamental aspects that the QMS must address at a minimum, which are as follows:

  1. A strategy for regulatory compliance, including compliance with conformity assessment procedures and procedures for management of modifications to the devices covered by the system.
  2. Identification of applicable general safety and performance requirements and exploration of options to address those requirements.
  3. Responsibility of the management.
  4. Resource management, including selection and control of suppliers and sub-contractors.
  5. Risk management is set out in Section 3 of Annex I.
  6. clinical evaluation by Article 61 and Annex XIV, including PMCF.
  7. Product realisation, including planning, design, development, production, and service provision.
  8. Verify the UDI assignments made by Article 27(3) to all relevant devices and ensure the consistency and validity of the information provided by Article 29.
  9. Setting up, implementing and maintaining a post-market surveillance system in accordance with Article 83.
  10. Handling communication with competent authorities, notified bodies, other economic operators, customers and other stakeholders.
  11. Processes for reporting serious incidents and field safety corrective actions in the context of vigilance.
  12. Management of corrective and preventive actions and verification of their effectiveness.
  13. Processes for monitoring and measurement of output, data analysis and product improvement.

This list of minimum requirements highlights that the Quality Management System necessitates a documented procedure for all significant activities directly associated with individual medical devices, along with broader processes about the company’s overall operations.

The EU MDR does not impose specific requirements for a QMS. However, manufacturers are responsible for implementing appropriate content tailored to the risk class and organisational nature.

How do you implement a QMS that actually works?

Manufacturers can utilise harmonised standards, such as ISO, to aid in implementing MDR requirements. Compliance with recognised harmonised standards, like ISO 13485:2016 for Quality Management Systems, establishes a presumption of conformity with relevant aspects of the MDR.

ISO 13485 provides detailed provisions for developing QMSs that align with most MDR quality management requirements.

Manufacturers must, therefore, ensure that a system compliant with both ISO standards and the MDR requirements outlined in Article 10 is in place to address the comprehensive demands of quality management in the medical device industry.

A manufacturer’s quality management system will be assessed as part of the conformity assessment procedures outlined in MDR Annex IX to XI. Conformity assessment for Class Ir, Is, a Notified Body will carry out Im, IIa, IIb and III devices.

Formal evaluation and certification by a notified body are not conducted for Class I devices, but the QMS requirements still apply.

Regulation (EU) 2017/746 (IVDR): MDR IVDR Amendment Jan. 2023 

Regulation (EU) 2017/746 (IVDR): MDR IVDR Amendment Jan. 2023 

Introduction

Recent amendments to Regulation (EU) 2017/745, also known as the Medical Devices Regulation (MDR), have introduced significant changes to the timelines and conditions for placing certain medical devices on the market or putting them into service. This comprehensive analysis explores the key points of these amendments, focusing on the intricate timeline considerations. 

Paragraph 3 Amendments

Paragraph 3 has undergone crucial revisions, introducing new provisions (3a to 3g) that outline conditions and timelines for the placement of medical devices on the market or into service.

Let’s delve into the details of these Regulation (EU) 2017/746 amendments: 

3a. Derogation and Conditions

By derogation from Article 5, devices falling under paragraphs 3b and 3c may be placed on the market or put into service, subject to the fulfilment of conditions specified in paragraph 3d. 

3b. Placing Devices with Certificates

Devices with certificates issued under Directive 90/385/EEC or Directive 93/42/EEC, valid by virtue of paragraph 2, can be placed on the market until specific dates: 

– Until 31 December 2027 for class III devices and class IIb implantable devices (excluding specific items). 

– Until 31 December 2028 for class IIb devices (excluding those covered by the previous point), class IIa devices, and class I devices in sterile condition or with a measuring function. 

3c. Conformity Assessment Procedure

Devices with conformity assessment procedures under Directive 93/42/EEC, not involving a notified body, may be placed on the market or put into service until 31 December 2028, provided certain conditions are met. 

3d. Conditions for Placement

Devices can be placed on the market until the specified dates (3b and 3c) if the following conditions are met by 26 May 2024: 

– Continued compliance with relevant directives. 

– No significant changes in design and intended purpose. 

– No unacceptable risk to health or safety. 

– Implementation of a quality management system by the manufacturer. 

– Lodgement of a formal application for conformity assessment by 26 May 2024 and a written agreement signed with a notified body by 26 September 2024. 

3e. Application of MDR Requirements

In derogation from paragraph 3a, devices in paragraphs 3b and 3c are subject to MDR requirements for post-market surveillance, market surveillance, vigilance, and registration of economic operators and devices. 

3f. Responsibilities of Notified Bodies

The notified body issuing the certificate in paragraph 3b remains responsible for surveillance unless agreed otherwise. A transition of surveillance responsibilities is outlined in agreements between manufacturers and notified bodies. 

3g. Derogation for Class III Custom-made Implantable Devices

Class III custom-made implantable devices can be placed on the market until 26 May 2026 without a certificate, provided a formal application is lodged by 26 May 2024, and a written agreement with a notified body is signed by 26 September 2024. 

Paragraph 4 Replacement

Paragraph 4 stipulates that device lawfully placed on the market before 26 May 2021, and those placed afterward under paragraphs 3a, 3b, 3c, and 3g, may continue to be made available or put into service. 

Article 122 Amendments

Article 122 outlines amendments related to the repeal of Directives 90/385/EEC and 93/42/EEC, effective from 26 May 2021. Noteworthy points include the continuation of Directives’ application for devices in specific paragraphs of Article 120(3a) to (3f) and (4).

Article 123 Amendments

In Article 123(3), point (d), the amendment includes a reference to Article 120(3e), further emphasizing the continued application of certain requirements from the repealed Directives. 

Regulation (EU) 2017/746 Amendments

The amendments to Regulation (EU) 2017/746, also known as the In Vitro Diagnostic Devices Regulation (IVDR), focus on Articles 110 and 112. 

Article 110 Amendment

Devices lawfully placed on the market under Directive 98/79/EC before 26 May 2022, and those placed afterward under paragraph 3 of this Article, may continue to be made available or put into service. 

Article 112 Amendment

For devices referred to in Article 110(3) and (4) of the IVDR, Directive 98/79/EC shall continue to apply to the extent necessary for the application of those paragraphs. 

Conclusion

The recent amendments to MDR and IVDR introduce a complex framework of conditions and timelines for the placement of medical devices on the market. Stakeholders, including manufacturers and notified bodies, must carefully navigate these provisions to ensure compliance and a smooth transition to the new regulatory landscape. 

Reference Link: https://health.ec.europa.eu/system/files/2023-01/mdr_proposal.pdf

Navigating Medical Device Regulations: A Comprehensive Guide to Market Access in Europe, Switzerland, and the UK

Navigating Medical Device Regulations: A Comprehensive Guide to Market Access in Europe, Switzerland, and the UK

Introduction and Guide to Market Access

In the intricate landscape of medical device regulations, successfully bringing products to market requires a thorough understanding of the varying requirements in different regions.

This market access guide provides comprehensive insights into the European Union (EU), Switzerland, and the United Kingdom (UK) regulations, shedding light on crucial aspects such as Authorized Representatives, Importers, and other economic operators. 

Crafting your Marketing Strategy

A well-defined marketing strategy is the foundation for entering any market. It is essential to carefully consider the products you wish to sell and the targeted regions. While the instinct might be to reach every corner, strategic planning helps avoid unnecessary costs. 

 Post-Brexit, the complexity has increased, necessitating separate Authorized Representatives and Importers for each region. 

Understanding Economic Operators

Authorized Representatives

In the EU, a manufacturer outside the region must appoint an Authorized Representative.

The Authorized Representative, prominently identified on product labels, shoulders responsibilities such as verifying EU conformity, registration obligations, and cooperation with competent authorities. 

EU MDR Article 11: Key Responsibilities of Authorized Representatives

  • Verify the EU declaration of conformity and technical documentation. 
  • Keep copies of technical documentation and the EU declaration of conformity. 
  • Comply with registration obligations. 
  • Provide information to demonstrate device conformity. 
  • Forward requests from competent authorities to the manufacturer. 
  • Cooperate on preventive or corrective actions. 
  • Immediately inform the manufacturer about complaints and suspected incidents. 
  • Terminate the mandate if the manufacturer acts contrary to obligations. 

Importers

Importers situated within the EU play a pivotal role in ensuring products’ adherence to regulations before entering the market. They verify CE marking, proper labelling, and other compliance criteria.

Significantly, they are obliged to keep meticulous records and promptly address non-compliance concerns. 

EU MDR Article 13: Duties of Importers

  • Place on the market only devices in conformity with the regulation. 
  • Verify CE marking, EU declaration of conformity, and manufacturer’s identification. 
  • Ensure proper labeling and instructions for use. 
  • Verify UDI assignment by the manufacturer. 
  • Maintain a register of complaints, non-conforming devices, recalls, and withdrawals. 
  • Cooperate with authorities on corrective actions. 
  • Inform the manufacturer and authorities about non-compliance and serious risks. 

The European Market

EU MDR 2017/745 and IVDR 2017/746

For medical devices and in-vitro diagnostics, compliance with EU MDR and IVDR is paramount. Manufacturers must meticulously follow the regulatory requirements outlined in these legislations.

Initiating with Article 10 and ensuring conformity with EU standards is the cornerstone. 

EU MDR Article 10: General Obligations of Manufacturers

  • Verify compliance with legislation, specifically EU MDR or IVDR Article 10. 
  • Comply with the requirements of EU MDR or IVDR Article 10 for economic operators. 
  • Provide necessary information to authorized representatives and importers. 

Authorized Representative

The EU Authorized Representative must be well-versed in EU MDR and IVDR requirements. The role encompasses tasks from verifying documentation to cooperating with authorities.

Transparency is critical, with the Authorized Representative’s details prominently displayed on product labels. 

Importer

Importers act as the last line of defence before products hit the market. As per Article 13, their verification processes ensure that only compliant devices enter the EU.

The importer’s role includes handling complaints, cooperating with competent authorities, and maintaining a comprehensive register. 

EUDAMED Registration

EUDAMED, the European Database for Medical Devices, plays a pivotal role in the regulatory landscape. Manufacturers, Authorized Representatives, Importers, and other entities must register in EUDAMED to obtain the Single Registration Number (SRN).

This digital hub facilitates information exchange, ensuring transparency and traceability. 

EUDAMED Registration Process

EUDAMED, the European Database for Medical Devices, is pivotal for transparent information exchange among stakeholders. The registration process involves: 

1. Identify your Role

Determine if you’re a Manufacturer, Authorized Representative, or Importer, each with unique responsibilities.

2. Access EUDAMED

Create an account on the user-friendly EUDAMED platform

3. Provide Details

Enter essential company information and specify your role.

4. Verification

Undergo a verification process to confirm the legitimacy 

5. Get SRN

Receive a Single Registration Number (SRN) upon successful verification.

6. Maintain Compliance

Regularly update the information to stay compliant. 

7. Information Exchange

Utilize EUDAMED for efficient information exchange with authorities and stakeholders. This streamlined process ensures regulatory compliance and facilitates seamless interaction within the EU’s medical device landscape. 

Switzerland

Post-Brexit

Switzerland, no longer part of the Mutual Recognition Agreement, mandates manufacturers outside the EU to appoint Authorized Representatives and Importers within Switzerland. The regulations mirror EU MDR and IVDR, emphasizing compliance. 

Differences in Switzerland

While Switzerland aligns closely with EU regulations, distinctions exist. The CH-REP symbol stands in for the EC REP symbol, and a unique registration process, distinct from EUDAMED, adds a layer of complexity. 

UK Market Access: Navigating the Post-Brexit Scenario

The UK Responsible Person

Post-Brexit, the UK Responsible Person assumes a role akin to the EU Authorized Representative. The UK MDR 2002 sets out responsibilities, emphasizing conformity checks, complaint management, and immediate reporting of non-compliance. 

UK MDR 2002 Responsibilities of the UK Responsible Person

  • Ensure the declaration of conformity and technical documentation are in order. 
  • Keep copies of technical documentation and the declaration of conformity. 
  • Provide information to demonstrate device conformity to the MHRA. 
  • Cooperate with the MHRA on preventive or corrective actions. 
  • Immediately inform the manufacturer about complaints and suspected incidents. 
  • Terminate the legal relationship if the manufacturer acts contrary to obligations. 

Symbolic Absence

Unlike the EU, the UK lacks a designated symbol for the Responsible Person. The absence prompts a textual mention on labels. Notably, this requirement applies to UKCA-marked products post-Brexit. 

Conclusion

Navigating the regulatory landscape for medical devices demands a nuanced understanding of region-specific requirements.

From strategic marketing planning to compliance with EU, Swiss, and UK regulations, this guide provides a detailed roadmap for manufacturers aiming to ensure seamless market access while embracing the intricacies of post-Brexit realities.

EUDAMED is a pivotal component, serving as the digital nexus for regulatory information exchange, ensuring compliance and traceability.