Recent MDR updates from Commission

The European Commission has recently published a number of revised or new documents, as follows:.

• An updated Joint Implementation/Preparedness Plan on the Medical Devices Regulation (MDR, 2017/745);
• The long-awaited guidance document MDCG 2020-3 ‘MDCG guidance on significant changes in the context of MDR Article 120‘;
• MDCG 2019-8 v2: Guidance document: ‘Implant Card relating to the application of Article 18 Regulation (EU) 2017/745′;
• MDCG 2018-1 v3: Updated guidance on ‘Basic UDI-DI and changes to UDI-DI’;
• MDCG 2020-1: Guidance on ‘Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software’;
• MDCG 2020-2: ‘Class I Transitional provisions under MDR Article 120 (3 & 4)’;
• ‘State of play of joint assessments of Notified Bodies in the medical device sector’.

In addition, Team-NB has published a statement regarding the ‘Effect of Covid-19 on MDR Implementation‘, one day ahead of the Official Journal of the European Union publishing Commission Recommendation (EU) 2020/403 on ‘Conformity assessment and market surveillance procedures within the context of the COVID-19 threat’, available from here. The Recommendation basically states that the current legislation for personal protective equipment (PPE) and medical devices allows for derogations from certain aspects of the regulations concerned where such PPE and medical devices “are essential for healthcare workers, first responders and other personnel involved in the efforts to contain the virus and avoid its further spread”.