Heather Crawford and Evangeline Loh have provided insights into the new guidance issued by the Medical Device Coordination Group (MDCG) in December 2023, concerning exemptions from clinical investigation requirements for high-risk medical devices in the EU. This guidance, known as MDCG 2023-7, is crucial for medical device manufacturers operating in the EU, particularly for those dealing with Class III and implantable medical devices. The new European Union (EU) guidance on clinical investigation exemptions encompasses several key aspects that are essential for understanding its implications.
Firstly, it’s essential to recognize the regulatory context. This guidance interprets Article 61, specifically paragraphs (4)-(6), of the Medical Devices Regulation (MDR) (EU) 2017/74. This article mandates the requirement for clinical investigations, particularly for Class III medical devices and implantable high-risk medical devices. The guidance provides criteria for exemption from these clinical investigations, as outlined in MDCG 2023-7. It delineates four distinct cases where exemptions are allowed. These cases cover a range of scenarios, including modified and legacy devices, devices listed in the exempted implant category, and situations involving the equivalence of devices from different manufacturers.
Clinical Investigation Exemptions for High-Risk Medical Devices
- Case 1, under Article 61(4), Indents 1-3, deals with modified devices. Specifically, it applies when a new device (DUE) is a modification of a device already marketed by the same manufacturer and can demonstrate equivalence to an equivalent device (ED).
- Case 2, as per Article 61(6)(a), pertains to legacy devices that were compliant with previous directives (AIMDD or MDD) and possess sufficient clinical data to support their exemption.
- Case 3, governed by Article 61(6)(b), relates to devices listed in Article 52(4), including certain implants, where adequate clinical data already exists, justifying their exemption.
- Case 4, found in Article 61(5), addresses scenarios where a DUE is equivalent to another manufacturer’s ED. However, in this case, a contractual agreement must be in place, enabling full access to the technical documentation.
Each of these cases comes with specific conditions, such as the requirement to demonstrate equivalence, the establishment of an appropriate Post-Market Clinical Follow-up (PMCF) plan, and compliance with product-specific common specifications (CS). Notably, Case 4 stands out as it necessitates a contractual agreement between manufacturers for accessing technical documentation, unlike the other exemption cases.
Elevating Transparency: EU Guidance on Exemptions for High-Risk Medical Devices
Prior guidance, notably MEDDEV 2.7/1, Revision 4, emphasized the need for notified bodies to challenge a manufacturer’s access to data on another manufacturer’s ED, although it did not explicitly mandate a formal contract. Manufacturers are expected to document the relevant exemption in their Clinical Evaluation Plan and Clinical Evaluation Report (CER), ensuring transparency and compliance.
In summary, the MDCG 2023-7 guidance provides critical clarification for manufacturers on the exemptions from clinical investigations for certain high-risk medical devices. It outlines specific criteria and conditions under which these exemptions apply and emphasizes the importance of documenting these exemptions in the clinical evaluation process. This guidance is a key development in the regulatory landscape of the EU’s medical device sector, affecting how manufacturers approach the development and approval of Class III and implantable high-risk medical devices.
Resource: Emergobyul, January 09, 2024
