The article provides an overview of the regulatory approach to be applied with respect to clinical investigations involving medical devices in the context of exemptions.
Table of content
The Medical Device Coordination Group (MDCG), a voluntary association of national regulating authorities in the sphere of medical devices collaborating for further improvement of the existing regulatory framework, issued a guidance document dedicated to the exemptions from the requirement to perform clinical investigations under Article 61(4)-(6) MDR, and also to “sufficient levels of access” to data needed to justify claims of equivalence.
The document highlights the key points related to the applicable regulation. Also, it provides additional clarifications and recommendations to be considered by medical device manufacturers and other parties involved to ensure compliance with it.
At the same time, provisions of the guidance are non-binding in their legal nature, nor are they intended to introduce new rules or impose new obligations.
The MDCG also reserves the right to change the guidance and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.
Introduction and Scope
The present guidance document issued in December 2023 is intended to clarify the exemptions from clinical investigation requirements under the EU Medical Device Regulation 2017/745 (MDR) for implantable and class III medical devices.
This includes conditions for demonstrating equivalence and circumstances under which clinical investigations are not mandatory.
Exemptions from Mandatory Clinical Investigations
First, the document outlines situations when exemptions from mandatory clinical investigations could be applied. In particular, the document explains several cases when clinical investigations are optional for implantable and class III devices, according to Article 61(4)-(6) of the MDR.
The exemptions are categorized into four cases:
- Case 1
Device modifications by the same manufacturer where the modified device is equivalent to the marketed device. - Case 2
Devices lawfully marketed under Directive 90/385/EEC or Directive 93/42/EEC with sufficient clinical data. - Case 3
Specific device types (such as sutures, staples, dental fillings, etc.) with sufficient clinical data. - Case 4
Devices demonstrated to be equivalent to a marketed device not manufactured by the same company, under certain conditions.
The document also emphasizes the independent nature of these exemption cases and the need for each to meet specific criteria.
Demonstration of “Sufficient Levels of Access to the Data”
Another important aspect addressed in the guidance relates to the requirements for demonstrating sufficient access to data to justify claims of equivalence.
In this respect, the document elaborates on the different access levels to data:
- Full Access: Through contracts or design modifications by the same manufacturer.
- Public Access: Using publicly available information.
- Contractual Access: For devices equivalent to those by other manufacturers, under specific conditions.
As further explained by the MDCG, each level of access has its limitations and methods to address these limitations.
The guidance also notes that a contract is not always required to demonstrate sufficient access to data.
Appendices
The guidance also contains appendixes describing in detail the approach to be followed.
Appendix I: Exemption Summary
Appendix I summarizes the cases when implantable and class III devices may be exempted from mandatory clinical investigations. It includes decision flowcharts outlining the criteria and considerations for each exemption case.
Appendix II: Hierarchy of Access Levels
Appendix II discusses the hierarchy of levels of access to data for demonstrating equivalence. It offers examples and addresses the potential limitations at each level of access.
This appendix is instrumental in guiding manufacturers in effectively demonstrating their products’ equivalence.
Conclusion
In summary, the present document is a comprehensive guide for manufacturers and notified bodies, detailing the exemptions from clinical investigation requirements under the MDR for implantable and class III medical devices. It clarifies the criteria for exemptions, the process of demonstrating equivalence, and the various levels of access to data necessary to justify equivalence claims.
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