Dear Anonymous,
Your question may be answered by reviewing the entire text of MDR Article 61(10), which is:
"Without prejudice to paragraph 4, where the demonstration of conformity with general safety and performance requirements based on clinical data is not deemed appropriate, adequate justification for any such exception shall be given based on the results of the manufacturer's risk management and on consideration of the specifics of the interaction between the device and the human body, the clinical performance intended and the claims of the manufacturer. In such a case, the manufacturer shall duly substantiate in the technical documentation referred to in Annex II why it considers a demonstration of conformity with general safety and performance requirements that is based on the results of non-clinical testing methods alone, including performance evaluation, bench testing and pre-clinical evaluation, to be adequate."
The intended purpose of the exemption is to recognize that for certain devices, conformity to GSPRs that would normally require clinical data, can be effectively demonstrated by other means, such as those listed in the Article, i.e., performance evaluation, bench testing and per-clinical evaluation. In some cases, conformity with consensus standards, preferably European harmonized standards, which adequately address safety and clinical performance requirements, may be relevant for this purpose.
The requirements for providing a justifiable rationale are specified in Article 61(10), i.e.,
"...adequate justification for any such exception shall be given based on the results of the manufacturer's risk management and on consideration of the specifics of the interaction between the device and the human body, the clinical performance intended and the claims of the manufacturer. It goes on to specify requirements regarding what needs to be included in the technical documentation referred to in Annex II.
Best regards,
Maria
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Maria E Donawa, M.D.
President, Donawa Lifescience Consulting Srl
Rome, Italy
medonawa@donawa.com+39 06 578 2665
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Original Message:
Sent: 14-Feb-2020 07:49
From: Anonymous Member
Subject: EU MDR Article 61 Clinical Evaluation, Paragraph 10
This message was posted by a user wishing to remain anonymous
I am evaluating how Article 61 Clinical Evaluation requirements and Annex VI may apply to a low risk Class I (non-measuring/non-sterile) medical device. The device has been on the EU market for several years. On page 14 of "MDCG 2019-15 Guidance Notes For Manufacturers Of Class I Medical Devices", there is a reference to an exemption of Clinical Evaluation requirements:
"In duly justified and substantiated cases, some Class I devices manufacturers may exceptionally demonstrate that the conformity with general safety and performance requirements based on clinical data is not deemed appropriate. Such a justification by the manufacturer must be based upon an evaluation of evidence in accordance with Article 61(10)."
What is the intended purpose of this exemption? What would be a justifiable rationale for applying this exemption?
Thank you in advance for your help with these questions.