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.
MedTech Europe’s proposed solution also seeks readiness for a future NB shortage and removal of bureaucracy from the NB designation process in terms of staffing, NBs’ past auditing records and notification delays. Gert Bos, executive director and partner at Qserve consultancy, recently discussed how the bottlenecks industry already is experiencing under the directives could worsen with the intent of NB designation delays “to clean house in the NB field” and the lack of EU-wide portfolio coordination.
The urgency for NB designation relates to the need for (re)certifications well ahead of the 26 May 2020 and 2022 application of MDR/IVDR, respectively, to avoid the potential of a “cliff-edge” scenario. The European Commission (EC) remains firm on its goal to designate at least 20 NBs against MDR by year’s end, but has now advised health care providers and health institutions to ask suppliers “in good time” about the availability of needed devices in recognition that some certificates may not be issued on time.
MedTech Europe CEO Oliver Bisazza told Focus the group made public “a standard deck” for its call to action based on different versions of a presentation on industry’s perspective on the implementation status of MDR/IVDR. “We did this in response to requests from various stakeholders who wanted more details about MedTech Europe’s position.” The group has circulated similar information in other ways since the regulations came into force in 2017. It issued a set of policy papers last July, flagged “burning points” in April and sent several open letters to the EC and national competent authorities in recent months. It also joined six other industry groups in a May joint statement to the EC and member states.