General notifications about medical devices

  • More resources to improve the patient safety of medical devices

    | 29 October 2019 |

    Patient safety is to be improved by a threefold increase in staff and a restructuring of the agency’s Medical Devices Unit into four specialised teams.

  • New concept for regulatory advice on medical devices

    | 28 August 2019 |

    The Danish Medicines Agency has launched a pilot project to offer targeted advice on rules and regulations in the area of medical advices to startups and small and medium-sized medical device manufacturers as well as educational and research units. New rules are under way throughout the EU from 2020.

  • Withdrawal of vaginal mesh

    | 03 May 2019 |

    Three types of vaginal mesh for surgical treatment of pelvic organ prolapse have been withdrawn in the USA after the FDA has assessed that the evidence of the products' efficacy and safety is insufficient. As a result, the products will no longer be available in Denmark.

  • Vaginal mesh from Bard removed from the EU markets

    | 12 March 2019 |

    The company Bard has decided to stop the sale of vaginal mesh implants on the markets in the EU. The decision is based on commercial reasons according to Bard.