New medical devices regulations

Updated 16 January 2019

New medical device regulations adopted


The European Commission has adopted and published the new EU regulations. They will apply after three years as regards medical devices and after five years as regards in vitro diagnostic medical devices.

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.

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices

Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices

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

Manufacturers of in vitro diagnostic medical devices

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


Unlike medicinal products, medical devices and in vitro diagnostic medical devices are not subject to pre-market authorisation. Instead, medical devices undergo a conformity assessment to establish whether they meet the applicable standards.
Depending on the risk posed by a product, the assessment of the technical documentation of a device may be performed by a notified body. The scope of controls carried out by notified bodies varies from one country to another. The new regulation will harmonise and strengthen the rules in this area.

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.

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