Dekra Certification B.V., the Netherlands-based notified body of the worldwide product certification firm, is now designated to review products under the European Medical Device Regulation (MDR), per an official listing Saturday in a European Commission database.
It's the third notified body in the Netherlands and eighth total allowed to perform certification work ahead of the May 26, 2020, compliance deadline for EU MDR, which requires more medical devices to undergo premarket notified body review than were required under the preceding Medical Device Directive.
- Dekra's German notified body previously received MDR designation, and is also one of two firms designated under the In Vitro Diagnostic Regulation (IVDR).
With the Saturday designation of Dekra Certification B.V., the total number of notified bodies available for EU MDR-related work is slowly inching closer to the 20 firms members of the European Commission had envisioned earlier this year might by designated by the end of 2019.
But EU Commissioner for Health Stella Kyriakides told the Employment, Social Policy, Health and Consumer Affairs Council last week 20 notified bodies will not be reached by the end of the year. She expects the goal to be reached during the first quarter of 2020.
Notified bodies designated under incoming medical device and in vitro diagnostic regulations
|Jan. 2019||Oct. 2019||BSI||U.K.|
|May 2019||TÜV SÜD||Germany|
|Aug. 2019||Oct. 2019||Dekra||Germany|
|Sept. 2019||TÜV Rheinland||Germany|
|Nov. 2019||DARE!! Services B.V.||Netherlands|
MedTech Europe said in a Nov. 26 statement that "despite the industry's efforts to get ready, we remain seriously held back by the slow and piecemeal implementation of the new regulatory framework."
"MedTech Europe recognises and welcomes the increased political attention to the MDR in recent months, and the efforts of the European Commission and Member States to find solutions to that Regulation's transition challenges, especially the low availability and capacity of Notified Bodies," the statement said.
Up for consideration in Parliament this week is a corrigendum to EU MDR, issued by the European Council Nov. 25, that would push back the regulation's implementation date for certain Class I medical devices by four years. Such a delay would reduce some strain on the few notified bodies that have been designated.
And although the EU MDR implementation date precedes that of IVDR by about two years, MedTech Europe has also drawn attention to lack of preparedness in the IVDs sector.
"While it is critical to maintain this political commitment to find pragmatic solutions to the MDR implementation, we also firmly believe that the EU is long overdue in devoting the same level of attention and energy to the IVD Regulation," the industry group said in the same statement.
In order to meet compliance by May 2022, more than 330 in vitro diagnostic products would need to be certified by notified bodies each week, MedTech Europe noted. As of Nov. 26, about 10 notified body organizations had applied for IVDR designation, according to the statement.