MDCG rolls out host of new guidances and updates with MDR looming

With 26th May fast approaching, the Medical Device Co-ordination Group (MDCG) has published three new guidances, two updated guidances and an implementation/preparedness plan for the incoming Medical Device Regulation (MDR).

Member states and the European Commission (EC) have been working together to ensure that the new MDR legislation is operational from 26th May 2020. Their implementation/preparedness plan outlines their key objectives and priority areas for action including establishment of the EUDAMED database, increasing the number of notified bodies, medical device shortages, legacy devices and other implementing acts.

In addition to the implementation/preparedness plan, the MDCG have released a guidance to provide clarification on the changes to a legacy device that should be considered significant in terms of design or intended purpose, under MDR article 120(3).

Furthermore, they have recently released guidance offering more details for firms and notified bodies on clinical evaluations (MDR) and performance evaluations (IVDR) for medical device software. A new guidance has also been published on class I transitional provisions under Article 120 (3 and 4) – (MDR), outlining information on the Declaration of Conformity which should be provided by manufacturers of class I devices, for which MDR certificates are required by 26th May 2024.

Finally, the MDCG has published its third update to a guidance on BASIC UDI-DI and changes to UDI-DI, and a second update to the guidance on implant cards required under MDR.

Joint Implementation/preparedness plan on the new Medical Devices Regulation 2017/745 (MDR)

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

MDCG 2020-1 Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software

MDCG 2020-2 Class I Transitional provisions under Article 120 (3 and 4) – (MDR)

MDCG 2019-8 v2 – Guidance document – Implant Card relating to the application of Article 18 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices

MDCG 2018-1 v3 Guidance on BASIC UDI-DI and changes to UDI-DI