EU: Five guidance documents published

The EU has published five additional guidance documents: Four on Regulation 2017/745 (MDR) and one on requirements for ventilators and accessories (MDCG 2020-9).

The four guidance documents on the MDR contain information about equivalence for clinical evaluation (MDCG 2020-5), handling clinical proof for "legacy devices" (MDCG 2020-6), a template for the PMCF plan (MDCG 2020-7), and a template for the associated evaluation report (MDCG 2020-8).