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Medical Device Regulation (MDR): role local EC + timelines EC  

If the clinical investigation with a CE-marked medical device, that is used within its intended purpose, is not considered to be a PMCF, only positive advice from the relevant EC(s) is necessary and “Regulatory pathway: EC only” needs to be followed. The “Other clinical investigations” are regulated under the Royal Decree of 18 May 2021 and as such a timeline of 45 days is applicable to issue an EC-decision.

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