MDR Article 61 (10): The European Union Medical Device Regulation (EU MDR) 2017/745 has introduced strict requirements for clinical evaluation and evidence as compared to the Medical Device Directive (MDD), the predecessor of EU MDR. Article 61 outlines the requirements for clinical evaluation of medical devices, with paragraph 10 offering an alternative route for demonstrating conformity with safety and performance requirements when appropriate clinical data is not available. Article 61(10) can be used when the performance and safety of the device must be demonstrated by non-clinical data as there are no relevant or meaningful measurable clinical criteria available.

This is the case for a medical device that does not provide a direct measurable clinical benefit, such as a medical device accessory, without its own clinical claim or direct influence on the clinical performance of the device with which it is intended to be used. In this case, an appropriate justification must be provided explaining why the manufacturer considers adequate demonstration of compliance with general safety and performance requirements based solely on the results of non-clinical test methods, such as performance evaluation, bench testing, simulated use, biocompatibility testing, compliance with harmonized, non-harmonized, technical standards and pre-clinical evaluation. Also, just because clinical data is not deemed appropriate, does not mean data should be excluded. As per Annex III of the MDR, screening of scientific literature should still be conducted to identify risks or any data that the manufacturer is unaware of. Legacy devices have PMS data and that should be considered as a part of the assessment.

Apart from implantable and Class III medical devices described in Article 61(4), manufacturers wishing to go for the Article 61(10) route are required to provide a detailed justification for this decision, this justification is based on firstly, effective Risk management, the manufacturer must document any potential risks associated with the device if risks are found to be minimal and can be managed then the manufacturer can rely on 61(10) route. Secondly, devices that do not interact with the human body or have limited interaction may qualify for Article 61(10). Lastly, for devices that offer indirect clinical benefits based on their technical performance, non-clinical evidence can be used to justify the claims, but these must be well supported with non-clinical test data. The justification for the use of Article 61(10) is therefore regulatory requirement.

This pathway is most relevant in specific situations:

• Legacy Devices: Devices that were previously CE marked under the MDD or AIMDD and have a strong track record of safe and effective use.
• Well-Established Technologies: Devices based on mature technologies that have documented safety and performance profiles.
• Low-Risk Devices: Class I or IIa devices where the risks of conducting new clinical investigations might not justify the potential benefits.

For higher-risk devices, such as Class IIb and III, proving equivalence and meeting the required data standards can be more challenging. Manufacturers may need additional justifications or consider conducting clinical investigations if necessary.

While Article 61(10) provides flexibility, it also presents challenges such as difficulties in showing equivalence, particularly for devices with unique features, ensuring data sufficiency as manufacturers must present enough clinical data to cover all safety and performance aspects, and addressing regulatory scrutiny. To tackle these challenges the manufacturer should prepare a comprehensive CER that aligns with the regulations, use strong PMS and PMCF systems to enhance existing data and maintain open and proactive communication with notified bodies.

The Article 61(10) pathway is a valuable option for demonstrating alternative routes for demonstrating conformity with safety and performance requirements when appropriate clinical data is not available. It’s particularly advantageous for legacy devices and well-established technologies that need to comply with MDR. By following the principles in the EU MDR and using guidance from MDCG and MEDDEV, manufacturers can meet regulatory demands while ensuring patient safety and device effectiveness. Early planning, detailed documentation, and active collaboration with Notified Bodies will be essential for making this pathway successful.

Author: Dr Saryu Thagi, Clinical Writer & Consultant