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The placing on the European market of drug-device combination products or substance-based medical devices is regulated by the MDR. Manufacturers must comply with the requirements of this regulation, and it is important to choose a Notified Body that understands the challenges medical device manufacturers face in bringing compliant products to market efficiently.
CE Marking for substance-based medical devices (Rule 21)
These types of medical devices are regulated by Rule 21 of the MDR and must comply with specific GSPRs.
CE Marking for combination medical devices (Article 117)
Article 117 of the MDR requires manufacturers of these devices to obtain a Notified Body Opinion (NBOp) confirming that the device complies with the relevant GSPR and to provide an NBOp report.
BSI’s Medicinal and Biologics team
BSI is a full scope Notified Body and UK Approved Body and its services combine efficiency with the integrity, independence and rigour that manufacturers expect from BSI.
The Medicinal and Biologics team is an experienced team covering a wide range of medical devices: our experts have extensive experience in providing MDR Conformity Assessment services to the medical device sector, spanning MDR Rules 14, 18 & 21, and for providing MDR Article 117 Notified Body Opinion (NBO) to the pharmaceutical sector
