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I completely agree with the comment from Anonymous that "FDA has lots of expertise, used in drafting both guidance and regulations. But their expertise is a small fraction of the expertise existing across the industry, especially in areas of rapid scientific development. Comparing their draft documents ...

Further to my previous response on this topic, there is one circumstance where a PMCF Plan is not required under the MDR, and the detail of this single exclusion is supported by guidance documents. This exclusion is identified in MDR Annex III, 'Technical Documentation on Post-Market Surveillance', ...

Dear Anonymous, The exception to the requirement of not conducting some type of PMCF activity is where the demonstration of conformity with general safety and performance requirements based on clinical data is not deemed appropriate as specified in MDR Article 61(10). It should be noted, however, ...

Dear anonymous, The requirement under the MDR in Annex XV regarding the need to appoint an independent monitor (Chapter III, Section 4) is separate and distinct from the requirement in Article 72(2). That is, Article 72(2) does not provide any flexibility regarding the requirement to appoint an ...

Hello Ming, I completely agree with your conclusion that a Clinical Evaluation Report (CER) is not required for the type of combination product being developed. The basic requirement for drug delivery combination products is described in the second paragraph of MDR Article 1(9), which requires: ...