The new EU regulation on medical devices comes into force on 26 May 2021

The transitional period for the Medical Devices Regulation (EU 2017/745) has come to an end and the new EU Regulation applies from 26 May 2021. The regulation replaces the old directives on medical devices (MDD) and implantable devices (AIMDD). The MD Regulation is directly applicable throughout the EU.

The aim of the reform is better patient safety

The main objective of the MD Regulation is to improve patient safety of medical devices in the European Union.

“Patient safety will be improved, for example, by more detailed requirements for the marketing and labelling of medical devices,” says Susanna Peltoniemi, Head of Unit at Fimea. “In the future, distributors must also ensure that the product has a declaration of conformity and is appropriately labelled”.

Patient safety will also be improved through the following changes:

• Mandatory quality system for all manufacturers.
• Registration to the common European database on medical devices EUDAMED: EUDAMED has an operator module in place and manufacturers complying with the regulation are required to register.
• Responsibilities for manufacturers, authorised representatives, importers, and distributors in the distribution chain: Each operator in the distribution chain must ensure that the product is accompanied by a declaration of conformity and is appropriately labelled.
• The traceability of devices is improved by requiring devices to have a Unique Device Identifier (UDI).
• An implant card for the patient becomes mandatory.
• Clinical evaluation: Stricter requirements for clinical evaluation from the point of view of patient safety.
• Surveillance of Notified Bodies: New requirements for conformity assessment and supervision of Notified Bodies carrying out assessments.

Where can I find information about the new MD Regulation?

Fimea's medical device website has been updated in accordance with the MD Regulation.

Comprehensive guidance is also available on the EU Commission's website. 

Fimea held a press conference on 6 May, 2021. The event was recorded and the recording will be available on the website later.