2019 was a year of firsts for BSI. Our UK Notified Body was the first in the world to receive MDR designation, the first to issue an MDR certificate to a client, and the first to receive full-scope designation to the IVDR. Since then, our new Netherlands Notified Body also achieved full-scope designation to both regulations, making BSI the only notified body with two full-scope designations to the IVDR and MDR.
2020 kicks off with another fantastic achievement as we become the first ever to issue a Notified Body Opinion to a manufacturer under Article 117 of the Medical Devices Regulation. This is thanks to our team here at BSI for working incredibly hard to provide this expertise to our clients.
Introduced by the European Commission under the new MDR, Article 117 requires manufacturers placing drug-device combination products onto the market as an integral device and marketing them as a “medicinal product” to seek Notified Body Opinion. The notified body then confirms the device is compliant with the relevant General Safety and Performance Requirements and provides an opinion to the Medicines Competent Authority to confirm compliance.
BSI has formed a dedicated Medicinal and Biologics Team to provide guidance on Article 117 and focus our full attention on this challenging area of new EU regulation. Our team of experts has over 55 years’ combined experience in drug development, GMP systems and controls, and QBD.
If you need guidance on Article 117 and whether your drug-device combination product requires Notified Body Opinion, the best place to start is our medicinal and biologics web page.
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