• Regulatory NewsRegulatory News

    Novartis Inhaler is First Device to be Certified Under MDR

    BSI’s UK notified body announced Wednesday that the Novartis Concept1 inhaler is the first device to be certified under the new EU Medical Devices Regulation (MDR). While previously classified as a Class I device, meaning it did not need to be reviewed by a notified body, the inhaler is now a Class IIa device under Rule 20 of MDR, which requires the notified body review. Gary Slack, SVP of medical devices at BSI said:  “As a result of being the first designated EU N...
  • Regulatory NewsRegulatory News

    MHRA Mulling Brexit Implications as UK’s BSI Says it Will Remain an EU Notified Body

    The UK’s drug and medical device regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), said Monday it is still working to understand the full ramifications of the country’s departure from the EU. “Following the result of the referendum on the UK’s membership of the European Union, the focus of the Medicines and Healthcare products Regulatory Agency continues to be on our public health role,” the agency said on Monday. “We will continue to work to the...