MDCG publishes multiple guidelines from CIE group

The EU Medical Devices Coordination Group (MDCG) has just published new and revised guidance documents from the Clinical Investigation and Evaluation (CIE) Working Group on its ‘MDCG endorsed documents‘ webpage.

The new guidelines are:

• MDCG 2020-5 Guidance on Clinical Evaluation – Equivalence
• MDCG 2020-6 Guidance on Sufficient Clinical Evidence for Legacy Devices
• MDCG 2020-7 Guidance on PMCF Plan Template
• MDCG 2020-8 Guidance on PMCF Evaluation Report Template

The updated guideline is:

• MDCG 2019-3 rev.1 Interpretation of article 54(2)b