The European Commission confirms: it is preparing a proposal to postpone the implementation of the Medical Device Regulation (EU) 2017/745 with one year.
Today, the European Union’s advisory organ for medical devices, the Medical Device Coordination Group (MDCG) published three new guidance documents and revisions to several existing ones. The guidance documents provide information and explanations on specific issues related to the transition from the Medical Devices Directive (93/42/EC) to the Medical Device Regulation (EU) 2017/745 and the In Vitro Diagnostics Directive (98/79/EC) to the In Vitro Regulation (EU) 2017/746. The MDCG provides advice to the Commission and assists the Commission and the Member States in ensuring a harmonised implementation of medical devices Regulations (EU) 2017/745 and 2017/746. New MDCG guidance documents: MDCG 2020-1: Guidance on Clinical Evaluation (MDR)/Performance Evaluation (IVDR) of Medical Device Software: This guide provides the framework for identifying the appropriate level of clinical evidence required for Medical Device Software (MDSW) to meet the requirements of the MDR. MDCG 2020-2: Class I Transitional provisions under Article 120(3 and 4) – (MDR): This guide describes the relevant information to be included in the manufacturer’s Declaration of Conformity (DoC) under the MDD for Class I (non-sterile/non-measuring) devices that must have MDR certificates after May 24, 2024. MDCG 2020-3: Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD: This guide specifies what constitutes a “significant changes in design or intended purpose” under Article 120(3) of the MDR. It also states that such changes will no longer be issued new MDD/AIMDD certificates. Also, the device will be prevented from being placed on the market under the MDD/AIMDD after the implementation of the MDR. Finally, the guidance includes decision flowcharts to help manufacturers decide whether or not a change to a device will be considered significant. Revisions to existing guidances: MDCG 2018-1 v3: Guidance on BASIC … Read More