NANDO is richer for a new MDR accredited Notified Body, which brings us to 13 certification bodies designated under the new Regulation: MDC MEDICAL DEVICE…
MDCG: PMCF Templates, Equivalence, Clinical evidence for legacy devices
The European Commission also released this morning 4 important MDCG documents covering PMCF, namely template for a Plan and Report and guide on equivalence and…
MDR delay is official – new Regulation published in the Official Journal!
Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020 amending Regulation (EU) 2017/745 on medical devices, as regards the…
MDR delay approved also by the Council!
The Council of the EU agreed to the position of the European Parliament in a written procedure and adopted the REGULATION OF THE EUROPEAN PARLIAMENT…
European Parliament approves to move forward with MDR delay Proposal
In the final vote announced today at 16h, the European Parliament approved to move forward with the Proposal to delay the MDR (Regulation 2017/745 on…
Council gives green light to launch negotiations on MDR delay + MDCG Guidance on NB audits during COVID-19
The Council of the European Union agreed today to a Mandate for launch of negotiations with the European Parliament to delay MDR under urgent procedure.…
Pre-market clinical evaluation consultation procedure: Update to MDCG guidance
The MDCG updated its Interpretation document on Article 54 (2)b of the MDR that exempts certain already marketed class III and class II devices from…
EC Proposal to delay MDR: which provisions are affected?
The European Commission proposal for the MDR delay is now officially published and accessible through: https://ec.europa.eu/commission/presscorner/detail/en/ip_20_589 Proposal for a Regulation of the European Parliament and…
Planning of MDCG meetings updated
You can see below the MDCG and subgroups meetings, as foreseen for the next 6 months. Next meeting of the MDCG is only planned for…
MDR delayed for 12 months due to COVID-19?
The European Commission is proposing to delay the MDR for 12 months to fight the current COVID-19 outbreak! Watch a short video following today’s European…