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MDCG 2022-14: Transition to the MDR & IVDR – Reflections from NAMSA

Topic : Type : Briefing

On 14 June 2022, the European Health Ministers met and echoed concerns surrounding the preparedness of medical device and IVD manufacturers for Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) conformity. If left unaddressed, the lack of preparedness may lead to the disruption of the supply of devices needed for health systems and patients, and could also jeopardise the access of innovative medical devices to the European market.

In an effort to mitigate these concerns, the Medical Device Coordination Group (MDCG) issued a new guidance document on 26 August 2022 to ensure sufficient Notified Body capacity and preparedness of manufacturers in order for medical devices and IVDs to be certified under the MDR and the IVDR, respectively, within their defined transition periods.

This document consists of 19 recommendations, including 11 actions relating to increasing Notified Body capacity, 2 covering access to Notified Bodies, 3 on the increased preparedness of manufacturers and 3 other actions.

In this blog, Kevin Butcher and Alex Laan from ABHI member NAMSA, highlight some of the significant points covered in the MDCG document, and provide commentary on the proposals.