News about medical devices
| 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.
| 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.
Recommendations from Danish Medicines Agency on Applications for authorisation of clinical investigation of medical devices
| 20 February 2020 |
The new Regulation on Medical Devices (MDR 2017/745) will apply from 26 May 2020. The regulation sets out, among others, new rules for clinical investigations. Applications for authorisation of clin
| 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Three types of vaginal mesh for surgical treatment of pelvic organ prolapse have been withdrawn in the USA after the FDA has assessed that the evidence of the products' efficacy and safety is insufficient.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.
| 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.
| 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.
| 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.
| 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.
| 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.
| 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.
| 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.
| 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.