Dear Members,
Here are thereafter and attached in PDF format four MDCG (not binding) guidances released last mid April regarding subjects you might find of interest.
2020-04-23 05 MDCG 2020-5 Guidance on Clinical Evaluation - Equivalence
available from https://ec.europa.eu/docsroom/docum...
2020-04-23 06 MDCG 2020-6 Guidance on Sufficient Clinical Evidence for Legacy Devices
available from https://ec.europa.eu/docsroom/docum...
2020-04-24 MDCG 2020-7 Post-market clinical follow-up (PMCF) Plan Template. A guide for manufacturers and notified bodies
available from https://ec.europa.eu/docsroom/docum...
2020-04-24 MDCG 2020-8 Post-market clinical follow-up (PMCF) Evaluation Report Template. A guide for manufacturers and notified bodies
available from https://ec.europa.eu/docsroom/docum...
Best regards,
MME Team members