COCIR White Paper on MDR Article 61(10)

MDR Article 61(1) states that confirmation of conformity with relevant general safety and performance requirements (GSPRs) under the normal conditions of the intended use of the device, and the evaluation of the undesirable side-effects and of the acceptability of the benefit-risk ratio, shall be based on clinical data providing sufficient clinical evidence, including where applicable relevant data as referred to in Annex III.

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