New EU rules on medical devices set to strengthen patient safety

26 May 2021

Today new EU rules on medical devices enter into force. The new rules aim to strengthen patient safety and ensure that patients can benefit from new innovative devices. Medical devices cover anything from contact lenses to state-of-the-art surgical equipment.

The new and tightened EU rules coming into force today aim to ensure that medical devices, such as breast and hip implants, comply with EU patient safety requirements and can be traced in the unfortunate event of problems. The aim is also to ensure that patients can benefit from new innovative equipment.

As a result, stricter requirements are now imposed on companies that manufacture medical devices with the overall aim of ensuring that people can be treated with the safest and most efficient devices possible. 

“The field of medical devices is progressing at lightning speed, with new, innovative devices being developed constantly. While this has massive benefits for millions of people, it means more work for the authorities in terms of supervision and control. This regulation means that we can give people even better assurance that their devices work as intended”, said Thomas Wejs Møller, Head of Division at the Danish Medicines Agency.

Implications of the new rules:

  • Traceability of medical devices
    It becomes possible to identify devices throughout the EU – e.g. breast, hip or knee implants. This is made possible by a unique device identifier (UDI) which enables traceability of the product throughout the entire chain of supply from manufacturer to patient.
  • Improved transparency and coordination of information about medical devices
    A European database (EUDAMED) is being developed. In the long term, it will improve coordination and transparency of information regarding medical devices available on the European market. Consumers and healthcare professionals will have access to information about medical devices.

  • Stricter requirements for clinical testing of medical devices
    Stricter requirements will be imposed on clinical testing of medical devices. This is to ensure the collection of data on device testing, quality, performance and safety. Several types of medical devices will also need to be tested before entering the market.

  • Stricter documentation requirements
    Manufacturers are also imposed stricter documentation requirements regarding the devices’ conformity – e.g. whether clinical data show that the medical device is safe. Medical devices can only be marketed in the EU after CE marking. CE marking is evidence that the device conforms to the medical device legislation.

  • Stricter monitoring rules
    The rules are tightened for the so-called notified bodies and for the monitoring of them. Notified bodies are responsible for assessing the more critical types of medical devices (medium- and high-risk classes) before entry on the EU market. The notified bodies will now have a right and a duty to carry out unannounced on-site inspections at the manufacturer.

  • Safety enhancing expert panels
    The European Commission will have a new tool to keep an eye on the notified bodies. This will take place through a review procedure whereby an expert panel can make a statement on the notified bodies’ assessment of the manufacturers’ clinical evaluations.