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…