Europe – EU MDR/IVDR: MedTech Europe Looks to Tackle Implementation Delays

MedTech Europe outlined a 7-point plan to aid EU member states in implementing the medical device and in vitro diagnostic regulations’ (MDR/IVDR) new system with greater efficiency and at a faster pace.

With the increasing urgency to implement the new regulatory system on time, the 7-point plan serves as a call to action. It covers notified bodies (NBs), product re-certification, Eudamed, guidance, scientific bodies, delegated and implementing acts as well as harmonized standards. The first step is faster NB designation because only two NBs have been designated against MDR—BSI UK and TÜV SÜD—and none for IVDR so far, followed by ensuring the re-certification procedure can be applied in a uniform fashion.

Steps three and four call for deploying Eudamed with clear timelines and publishing guidance on high-priority areas such as software classification and unique device identification, among others. The other points seek quick setup of the expert panels and EU reference laboratories and making available the “most-needed” delegated and implementing acts and harmonized standards in high-priority areas first.

The plan follows on the heels of a notice from two delegations that raised awareness of the concern industry continues to express with NB capacity, which they described as “the most imminent and high-profile challenge” to MDR and IVDR.An EU-wide solution to designate NBs faster should ensure that CE marking can continue even if manufacturers “temporarily become ‘orphans’” in the event of losing an NB, according to MedTech Europe. This coincides with recent decisions some NBs made to not apply for MDR or IVDR designation, including Lloyd’s Register Quality Assurance and Swiss NB QS Zürich AG