New medical devices regulations
New medical device regulations adopted
The Danish Medicines Agency would like to give guidance on the new regulations so that companies and the healthcare sector can prepare for the new changes and requirements.
The regulations will strengthen patient safety and ensure the availability of new devices, which will be of benefit to patients.
Improving the safety of medical devices
The regulations will improve the safety of medical devices in two ways:
- by strengthening the rules on placing new medical devices on the market
- by tightening surveillance once they are available on the market.
The regulations will strengthen the rules on clinical investigations of medical devices seeking to increase the availability of reliable clinical data. Manufacturers must meet stricter requirements as to the quality, performance and safety of medical devices placed on the market.
The rules on notified bodies and the authorities’ monitoring of notified bodies will also be strengthened. Notified bodies are responsible for assessing medium-risk and high-risk medical devices before the products can be placed on the market in the EU. With the implementation of the new regulations, the notified bodies will also get a right and duty to perform unannounced on-site audits of manufacturers.
More transparency for patients and increased traceability
Another safety aspect of the new regulations is the further development of the central European database, Eudamed. The new Eudamed will provide information on manufacturers, notified bodies, clinical investigations, certificates, medical devices and incidents involving medical devices. Moreover, the database will provide information about the products marketed in the EU. Authorities, patients, healthcare professionals and the public will get access to Eudamed. The general public will get access to non-confidential information on manufacturers and devices in Eudamed.
In addition, the new regulations stipulate that medical devices must have a unique device identification (UDI) to facilitate the traceability throughout the supply chain from manufacturer to patient.
Manufacturers of medical devices
- Factsheet for manufacturers of medical devices. In the factsheet for manufacturers of medical devices you can see how the regulation on medical devices impacts manufacturers and read the frequently asked questions.
- Implementation model for medical devices regulation –step by step guide
Manufacturers of in vitro diagnostic medical devices
- Factsheet for manufacturers of in vitro diagnostic medical devices. In the factsheet for manufacturers of in vitro diagnostic medical devices you can gain an overview of how the regulation on in vitro diagnostic medical devices will impact manufacturers and read the frequently asked questions.
- Implementation model for in-vitro diagnostic medical devices regulation – step by step guide
Why are the new regulations needed?
Medical devices and in vitro diagnostic medical devices are becoming ever more sophisticated and innovative. Existing rules date back to the 1990s and have not kept pace with scientific and technical developments in the healthcare sector.
Medical devices not subject to pre-market authorisation
Traceability across the EU is difficult, because several member states have set up own registration tools that are not always compatible with each other. The use of different systems in different countries also place an unnecessarily heavy burden on manufacturers who want to market a product in more than one country.
In addition to improving the safety of medical devices, the new regulations seek to stimulate innovation. This is necessary as it is estimated that in 2060 there will be twice as many Europeans aged 65 or over, increasing the importance of safe and accessible medical devices and in vitro diagnostic medical devices for public health and medical care.
Changed classification rules for in vitro diagnostic devices
The regulation on in vitro diagnostic medical devices (IVD) will classify in vitro diagnostic medical devices in four risk categories, in line with the categorisation that already exists for other medical devices.
The risk classification of in vitro diagnostic devices will determine:
- The obligations placed on manufacturers and other economic operators
- The requirements for clinical investigations and clinical evidence
- The requirements for market surveillance by national authorities
Read more about the new classification of IVD in Annex VII to the new regulation.