News about medical devices
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.
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.
New campaign to prevent shortage of protective equipment: Denmark helps Denmark
| 23 March 2020 |
The healthcare services are running short of protective equipment such as face masks and visors in many areas of Denmark. The Danish Medicines Agency now launches the “Denmark helps Denmark” campaign, urging authorities, companies and others to report it if they have excess equipment or ideas on how to procure more.
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.
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.