Posted By
Maria Donawa
25-Feb-2022 02:19
Found In
Egroup:
Regulatory Open Forum
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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', ...
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