The Danish Medicines Agency has designated a new Danish body for certification of medical devices
Before medical devices can be placed on the market, they must be certified by a notified body in accordance with the regulations on medical devices and in vitro diagnostic medical devices if it is a medical device in a risk class higher than class I/A.
Such certification of medical devices can now be carried out by the Danish company TÜV SÜD Danmark ApS, which has been designated by the Danish Medicines Agency following a tender from the Danish Ministry of Industry, Business and Financial Affairs. TÜV SÜD Danmark ApS has been designated to certify medical devices within 39 device codes covering a wide range of innovative devices.
A notified body is tasked with reviewing manufacturers' technical documentation to assess whether the medical device fulfils the requirements of the legislation. If the device and the manufacturer fulfil all required requirements and standards, it is awarded a CE mark, indicating that the device is safe and effective and may be marketed in the EU.
The designation of TÜV SÜD Danmark ApS as a notified body has been pending since December 2020, when the company won the tender for the establishment of a notified body in Denmark. The Danish Medicines Agency's designation was carried out in co-operation with the Ministry of the Interior and Health, the Ministry of Industry, Business and Financial Affairs, the EU's Medical Device Coordination Group and the European Commission.
The long processing time is due to the extensive investigations into whether TÜV SÜD Danmark ApS has the necessary competences for the task and thus meets the applicable requirements for notified bodies in the Medical Devices Regulation.
In the future, it is the Danish Medicines Agency that will be responsible for the regular supervision of the company.
Read the full press release from the Danish Medicines Agency (in Danish)
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