General notifications about medical devices
| 26 May 2021 |
Today new EU rules on medical devices enter into force. The new rules aim to strengthen patient safety and ensure that patients can benefit from new innovative devices. Medical devices cover anything from contact lenses to state-of-the-art surgical equipment.
Relaxation: Information on face masks permitted to be in Swedish, Norwegian or English besides Danish
| 19 August 2020 |
The Danish Medicines Agency temporarily eases the requirement that the instructions for use and labelling of surgical face masks must be in Danish. This permits the sale of face masks with labelling and instructions for use in Swedish, Norwegian or English until 1 December.
| 22 March 2020 |
There is a risk that the healthcare sector will run out of protective equipment, such as hand sanitizer, facemasks and visors/shields, which are crucial in the fight against coronavirus. We urge everyone to use at little as possible without compromising on safety.
| 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.
| 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.
| 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Three types of vaginal mesh for surgical treatment of pelvic organ prolapse have been withdrawn in the USA after the FDA has assessed that the evidence of the products' efficacy and safety is insufficient.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.
| 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.