General notifications about medical devices
-
Danish Medicines Agency closed over Christmas and New Year
| 28 November 2023 |
The Danish Medicines Agency will be closed over Christmas and New Year, from Saturday 23 December 2023 to Monday 1 January 2024, both days included. Read which deadlines apply to applications within the Danish Medicines Agency's area in 2023.
-
Deadline for submission of applications for medical device export certificates in 2022
| 02 December 2022 |
The last day for submitting an application for a medical device export certificate will be 14 December 2022. Any application received after that will be considered received on 1 January 2023.
-
Deadline for submission of applications for medical device export certificates in 2021
| 14 December 2021 |
The last day for submitting an application for a medical device export certificate will be 15 December 2021. Any application received after that will be considered received on 3 January 2022.
-
New EU rules on medical devices set to strengthen patient safety
| 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.
-
Risk of supply failure: Use protective equipment rationally
| 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.
-
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.