EU MDR Article 61

Clinical Evaluation

The European Union (EU) Medical Device Regulation 2017/745 (EU MDR) aims to ensure a high level of protection of human health and safety as well as the smooth functioning of the internal market for medical devices in the EU. The EU MDR introduces new and stricter requirements for the clinical evaluation of medical devices.

Clinical evaluation is a systematic and ongoing process of collecting, appraising, and analyzing clinical evidence pertaining to a medical device to verify its safety and performance, and to determine its clinical benefits and risks. The clinical evaluation is an essential part of the conformity assessment procedure that medical device manufacturers must follow to obtain the CE marking and place their devices on the EU market. The CE marking indicates that the device complies with the applicable requirements of the EU MDR, including that the device meets the general safety and performance requirements (GSPRs) set out in Annex I of the EU MDR and that the device is suitable for its intended purpose.

Article 61 of the MDR specifies the requirements for clinical evaluation and outlines the roles and responsibilities of the manufacturer, the notified body (NB), and the expert panel (as relevant) in conducting and reviewing the clinical evaluation. According to Article 61, the manufacturer is responsible for preparing a clinical evaluation plan (CEP), which defines the scope, methods, and criteria for the clinical evaluation, and a clinical evaluation report (CER), which documents the results and conclusions of the clinical evaluation. The NB is responsible for assessing the CEP and the CER. The expert panel is responsible for providing scientific advice and recommendations to the NB and the manufacturer for high-risk or innovative devices, in particular.

The clinical evaluation of a medical device must follow a defined and methodologically sound procedure based on the following principles:

• The clinical evaluation shall be conducted by suitably qualified personnel who can demonstrate relevant clinical, scientific, or technical expertise and who are impartial. The qualifications, experience and tasks of the clinical evaluators shall be documented and justified.
• The clinical evaluation shall be appropriate in view of the characteristics of the device and its intended purpose. The clinical evaluation shall consider the risk class of the device, the novelty of the technology, the target population, the intended user and user environment, the type and extent of the clinical benefits expected, and the method of application of the device.
• The clinical evaluation shall be based on sufficient clinical data, which may include data from clinical investigations, clinical experience, scientific literature, or a combination thereof. The clinical data shall be relevant, reliable, robust, valid, and verifiable, and shall demonstrate the conformity of the device with the GSPRs, as well as any specific claims made by the manufacturer.
• The clinical evaluation shall be performed in accordance with the relevant guidance provided by the European Commission, such as MEDDEV 2.7/1 revision 4 and the guidelines issued by the Medical Device Coordination Group (MDCG). The clinical evaluation shall follow a clear and transparent methodology, which shall include the definition of the scope, objectives, criteria and methods of the evaluation, the identification, appraisal and analysis of the clinical data, the generation of the clinical evidence, and the assessment of the clinical performance and clinical benefits of the device.
• The clinical evaluation shall be documented in a clinical evaluation report (CER), which shall be updated throughout the life cycle of the device whenever new information becomes available. The CER shall provide a critical appraisal of the clinical data and evidence, the results and conclusions of the clinical evaluation, and the limitations and gaps of the clinical evaluation. The CER shall also identify the need for further clinical investigations or post-market clinical follow-up, and the risk-benefit ratio of the device.

Under the EU MDR, it is up to the manufacturer to specify and justify the level of clinical evidence necessary to demonstrate conformity with the relevant GSPRs.

For certain devices, such as accessories to medical devices, manufacturers may determine that performing clinical evaluation following an approach aligned with EU MDR Article 61(10) is appropriate. This approach is based on the results of the manufacturer’s risk management and on demonstration of conformity based on results of non-clinical testing methods alone (including performance evaluation, bench testing, and pre-clinical evaluation). This approach does not apply to Class III or implantable devices. Further, if a manufacturer of a medical device is making clinical claims from its clinical performance thato a clinical benefit, then clinical data are required and should be evaluated by the manufacturer; in these circumstances EU MDR Article 61(10) no longer applies.

Expert Guidance

Just because clinical data are deemed not appropriate for certain clinical evaluations in accordance with EU MDR Article 61(10), does not mean these data, if available, should be excluded. This clause allows for demonstration of conformity to GSPRs without clinical data. However, in alignment with Annex III of the EU MDR, screening of scientific literature should still be conducted to identify risks or any data that the manufacturer is otherwise unaware of. EU MDR Article 61(10) is not a route for devices where there is a lack of clinical data – it is for devices where clinical data are not appropriate.

Our scientific communications team can offer expert guidance and support for your EU MDR Article 61 clinical evaluation; contact us today to discuss your clinical evaluation needs 855.463.1633.