MDR - annex XIV - PArt A - article 2

Original text

Expert opinion

2. The clinical evaluation shall be thorough and objective, and take into account both favourable and unfavourable data. Its depth and extent shall be proportionate and appropriate to the nature, classification, intended purpose and risks of the device in question, as well as to the manufacturer’s claims in respect of the device.

The clinical evaluation must be documented in a clinical evaluation report (CER) according to guidance MEDDEV 2.7/1 Revision 4. The evaluation should take into account all data, whether positive or negative, for the product in question. Further, the range of clinical literature and evidence assessed should reflect the risk classification and complexity of the medical device.


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