Device association MedTech Europe released a seven-point plan to help EU member states tackle the looming MDR/IVDR implementation deadlines.
The plan points out gaping holes in critical infrastructure. The call to action covers notified bodies for certification of new products, recertification, Eudamed, quality guidance, scientific bodies and harmonized standards.
MedTech Europe notes that the system is far from being functional with the implementation date for the MDR less than a year away. It says the first step is to designate notified bodes more quickly.
It urges member states to “acknowledge that we are not on track,” and to prepare for the lack of notified bodies. It calls for an EU-wide solution that ensures that manufacturers can continue CE marking.
The association suggests removing as much bureaucracy from the process as possible to accelerate NB designations. Regulators should also consider the NB’s past track record under the former directives, “instead of re-assessing everything from A to Z,” it said.
Another proposed solution is to create a staged re-certification procedure for NBs to follow that would give priority to product families that can’t use the grace period that allows a delay in implementing the requirements.
MedTech Europe calls for the new Eudamed database to be deployed with workable IT specifications and implementation timelines, and for regulators to publish guidance documents as soon as possible.
Read the seven-point plan here: www.fdanews.com/07-05-19-MedTechEuropeIVDRMDR.pdf.