European rules on medical devices

Medical devices cover a wide range of products: band aids, diagnostic analyses, advanced surgical instruments, implants and much more. Medical devices are governed by two regulations: the EU regulation on medical devices (effective on 26 May 2021) and the EU regulation on in vitro diagnostic medical devices (effective on 26 May 2022). The regulations replace the EU directives in the area. The regulations are directly applicable in the EU countries and in Denmark supplemented by national executive orders.

The purpose of the EU regulations is to improve patient safety and to ensure that new devices will benefit patients – in particular through supporting availability and tightening documentation requirements and monitoring of devices.

Tightening of supervision and inspection of medical devices

The regulations tighten, for instance, the rules for clinical testing of medical devices on patients so as to ensure the availability of evidence for testing of the devices. In addition, manufacturers of medical devices must meet stricter requirements in terms of following up on the quality, performance and safety of devices.

The rules are also enhanced for notified bodies and for the authorities’ supervision of notified bodies. Notified bodies are responsible for assessing and certifying medical devices in medium- and high-risk classes before medical devices may be marketed in the EU. The EU regulations also give the notified bodies the right and the duty to carry out unannounced on-site inspections at the manufacturer. You can read more about the different risk classes on this page.

European database on medical devices, EUDAMED

The EU regulations also provide for the establishment of a central European database on medical devices, EUDAMED. The new database will include information about manufacturers, notified bodies, clinical investigations, certificates, medical devices as well as serious deterioration in health caused by medical devices and/or medical device malfunction or failure. The database will moreover include information about medical devices marketed in the EU. Authorities, patients and healthcare professionals will have full access to EUDAMED, whereas the public will only have access to the databank’s non-confidential information about manufacturers and medical devices.

EUDAMED is expected to be ready and taken into use in 2023.

The EU regulations moreover require medical devices to have a Unique Device Identification (UDI) so that the product can be traced throughout the supply chain from manufacturer to patient.

For manufacturers in particular

Derogation rules

The EU regulations give national authorities the possibility to allow that a specific device be used in the country in question even though the conformity assessment procedures have not been followed if the use of the device is in the interest of public health or patient safety and health (article 59 of EU regulation 2017/745 on medical devices and article 54 of EU regulation 2017/746 on in vitro diagnostic medical devices).

The European Commission has the possibility of extending national derogations to the entire territory of the union in exceptional cases.

UDI Helpdesk

The European Commission has launched a UDI Helpdesk for medical device operators. The Commission’s helpdesk aims to provide support to economic operators in the implementation of the obligations and requirements introduced by the new UDI system, which include UDI assignment, labelling and registration of devices. 

The helpdesk can also provide support to manufacturers and other natural or legal persons on the use of the European Medical Devices Nomenclature (EMDN).

Products with living micro-organisms

With the entry into force of the medical devices regulation, it is no longer possible to market medical devices that contain or consist of viable biological material or viable organisms, including living micro-organisms, bacteria, fungi or viruses in order to achieve or support the intended purpose of the product; so provides article 1(6)(h) of the medical devices regulation (MDR 2017/745).

Products containing the above-mentioned organisms thus fall outside the scope of the regulation, regardless of whether individual products may have a certificate that has not yet expired and was issued under the previous medical devices directive. Manufacturers will need to clarify if the products in question may be marketed under other rules, e.g. the rules on food supplements, cosmetics or medicinal products.

Why are the new rules necessary?

Medical devices and in vitro diagnostic medical devices are becoming more and more advanced and innovative. The existing rules date back to the 1990s, and the legislation has not kept pace with the scientific and technological development in the healthcare sector.

Traceability across the EU is difficult since several member states have established their own registers that are not always compatible. The use of different systems in different countries also places an unnecessarily heavy burden on manufacturers intending to market products in more than one country.

Besides improving the safety of medical devices, the new regulations also aim to stimulate innovation. The pace of development in the medical devices industry is fast. And with the relatively short development cycle of some medical devices, new products are constantly introduced to the market, making it all the more important to ensure the availability of safe medical devices and in vitro diagnostic medical devices for public health and medical treatment.

Changed risk classification of in vitro diagnostic medical devices

The regulation on in vitro diagnostic medical devices (IVDs) changes the classification to four risk classes, aligning it with the classification already in place for other medical devices.

The risk classification for IVDs will impact the following:

You can find more information about the new classification of IVDs in Annex VIII of the new regulation.

Fact sheets on the regulation for (in Danish):

• manufacturers of medical devices
• manufacturers of class I medical devices
• manufacturers of in vitro diagnostic medical devices
• manufacturers of implantable medical devices

• healthcare professionals and health institutions

• purchasers of medical devices and in vitro diagnostic medical devices

• authorised representatives and importers and distributors of medical devices and in vitro diagnostic medical devices