MDCG 2020-5 Guidance on Clinical Evaluation - Equivalence.pdf
MDCG 2020-6 Guidance on Sufficient Clinical Evidence for Legacy Devices.pdf
The European Commission provides a range of guidance documents to assist stakeholders in implementing the medical devices regulations.
Legally non-binding guidance documents, adopted by the medical device coordination group (MDCG) in accordance with Article 105 of Regulation 745/2017, pursue the objective of ensuring uniform application of the relevant provisions of the regulations within the EU.
MDCG 2020-5 Guidance on Clinical Evaluation - Equivalence.pdf
MDCG 2020-6 Guidance on Sufficient Clinical Evidence for Legacy Devices.pdf
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