News about medical devices

  • Application deadlines in 2018

    | 06 December 2018 |

    The Danish Medicines Agency will be closed between Christmas and New Year from 22 December 2018 to 1 January 2019, both days inclusive. This means that enquiries made to the Danish Medicines Agency, with a few exceptions, will not be read and replied during this period. On this page, you can find the deadlines that apply to applications in the Danish Medicines Agency's area in 2018.

  • Medicines of the future in focus at World Economic Forum

    | 20 September 2018 |

    Medicines of the future is one of the topics being debated at the meeting of the World Economic Forum, which is currently place right now in Tianjin in China. The Danish Medicines Agency is attending.

  • Acupuncture needles with false CE marking

    | 16 April 2018 |

    Sterile acupuncture needles with false CE marking are sold online. We ask you to pay attention to these products because there is no documentation to support the product's sterility or the materials used to fabricate the device.

  • 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.

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