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News about medical devices

  • Think twice when you buy and use self-tests

    | 06 April 2017 |

    The Danish Medicines Agency has launched a new video as part of its health app campaign. The campaign encourages consumers to be critical when they use self-tests bought on the internet.

  • New campaign: Be critical when using health apps

    | 22 March 2017 |

    The Danish Medicines Agency has launched a new campaign on its website and Facebook to encourage consumers to be critical when they use health apps they have downloaded or bought on the internet.

  • New common EU rules on medical devices under way

    | 03 June 2016 |

    The Netherlands presidency of the Council and representatives of the European Parliament have reached political agreement on new EU rules on medical devices. The rules will strengthen patient safety and allow patients to benefit from new innovative devices.

  • The Danish Medicines Agency has a new website

    | 04 January 2016 |

    Today, the Danish Medicines Agency launched its new website – laegemiddelstyrelsen.dk/en – where you can read about and subscribe to news about licensing and supervision of medicines, side effects, reimbursement, pharmacies and medical devices.

  • Fees for medical devices in 2015

    | 05 January 2015 |

    The fees for medical devices have been adjusted in accordance with Danish Government regulations, including the fees for registration of manufacturers and devices, importers and distributors, assessment of applications for the authorisation for clinical investigation of medical devices, and amendments to investigations, as well as supervision and control of notified bodies in Denmark.

  • New rules for persons collaborating with the industry

    | 07 October 2014 |

    As of 1 November 2014, new rules governing healthcare professionals' collaboration with pharmaceutical and medical companies take effect. The rules governing association will be extended to include medical companies and nurses. Doctors' association with speciality stores trading in medical devices are also covered by the rules.

  • Criticism of CE marking of medical devices in Czech Republic and Slovakia

    | 26 October 2012 |

    The Danish Health and Medicines Authority has asked the European Commission to take action in a case concerning whether two named notified bodies in the Czech Republic and Slovakia comply with EU medical devices law.

  • Surgery with the da Vinci Surgical System resumed in Denmark

    | 10 July 2012 |

    Robotic surgery using the da Vinci Surgical System will resume Tuesday 10 July in Denmark, after having been halted for the past two weeks. The decision to resume surgery with the da Vinci Surgical System was taken by the five national robot centres based on an independent investigation and further documentation from the manufacturer Intuitive Surgical.

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