MDCG sounds the alarm over the pace of MDR and IVDR applications.

The European Commission’s Medical Device Coordination Group (MDCG) has warned medtech manufacturers to get certified under the new device and diagnostics regulations as soon as possible, in what may be its strongest message to the industry yet, while also calling on notified bodies to provide more clarity and certainty.

A widening gap

While more than 24,000 medical devices under the Medical Device Directive (MDD) need to transition to the MDR, manufacturers had submitted only around 13,000 devices for certification, with just 3,900 certificates issued through June 2023. In a position paper published on 29 November, the MDCG noted that although more manufacturers have applied under the MDR and IVDR, not enough are taking advantage of the extended timelines, and many applications are incomplete.

Even more pressing for IVDs

The situation is more acute for in vitro diagnostics: whereas around 8% of IVDs required notified body involvement under the old directive, roughly 80% do under the IVDR. The MDCG urged manufacturers, especially of higher-risk devices, to strengthen their transition efforts and submit complete, high-quality applications without further delay.