UPDATE: Nov. 6, 2019: BSI Group said Wednesday its notified body in the Netherlands is now designated under the forthcoming European Medical Device Regulation, as confirmed by an official listing in the NANDO database.
BSI said the scope of its designation includes categories of devices with specific characteristics newly introduced under MDR, like reusable surgical instruments, devices incorporating or consisting of nanomaterials, and custom-made class III implantable devices.
"Over the past two years, we’ve invested heavily in growing and training our people to be able to deliver MDR conformity assessments at this critical time for the industry," Manuela Gazzard, BSI's group director of regulatory services, said in a statement.
The designation marks the second MDR authorization for a BSI notified body. The company's U.K. operation was the first notified body allowed to complete work related to MDR, receiving the go-ahead in January. BSI U.K. became the first firm to certify a device under the new regulation, announcing in September it awarded a conformity certificate to a Novartis inhaler.
The U.K. operation also last month received designation under the In Vitro Diagnostic Regulation, the second notified body to do so.
Dive Brief:
- The medical certifications arm of Dutch notified body DARE!! Services B.V. is the latest firm designated under the European Medical Device Regulation, according to a publication in the European Commission's NANDO database Tuesday. It's the first such body operating out of the Netherlands.
- The designation allows the notified body to assess active non-implantable therapeutic devices.
- The news brings the total number of notified bodies authorized to accept work related to the forthcoming device regulation to six, while in vitro diagnostic manufacturers preparing for the EU's sister regulatory overhaul for IVDs currently have access to two notified bodies.
Dive Insight:
Notified body capacity is beginning to inch up for manufacturers looking to begin or continue selling medical devices in the EU after May 26, 2020, when the new set of regulations takes effect.
The European Commission green-lighted BSI's U.K. operation as MDR's first designated NB in January, followed by TÜV SÜD and DEKRA (both operating in Germany), IMQ (Italy), and most recently, TÜV Rheinland (Germany).
In vitro diagnostic makers only saw the first NBs available for IVDR work designated last month. DEKRA Germany and BSI U.K. are the sole firms that presently hold that designation.
Even as manufacturers can now work on getting products certified with the help of these private entities, industry is feeling the time crunch on achieving compliance by next spring.
European regulators have pushed back at least one major implementation deadline: The EC confirmed last week it will delay the launch of safety and performance monitoring database Eudamed by two years, meaning it will not go live until around the time IVDR takes effect in May 2022.
