New EU rules for medical devices

  Written on 22.08.2016

In May 2016, negotiations between the Dutch Presidency and the EU Parliament led to the agreement of two proposals for new EU regulations; one on medical devices and one on in vitro diagnostic medical devices. The regulations cover a broad spectrum of products in use for treatment and diagnosis, e.g. band aids, hip replacements, pacemakers, pregnancy tests etc.

In comparison to the technological development, the current legislation on medical devices and in vitro diagnostic medical devices, which is from the 1990’ies, was found to be outdated and inadequate. This has led to the proposals for the two new EU regulations.

According to the Commission, the regulations shall ensure both patient safety and that new innovative devices will benefit patients in treatments in a timely manner. This will be sought done by strengthening the rules on placing devices on the market and also by monitoring the market more intensively by e.g. implementing an “implant card” for patients that enables patients and doctors to trace which device that has been implanted.

The draft regulations also include specific provisions on manufacturers’ responsibilities as to the follow-up of the quality, performance and safety of devices placed on the market. Further, rules on certain high risk devices will be strengthened and such devices may undergo additional checks by experts before being placed on the market. Certain devices without a medical purpose but with similar characteristics as medical devices will also be covered by the new EU rules.

Central database

To help create an improved system, a central database shall be established to collect all relevant information. This database will cover economic operators, notified bodies, vigilance, certificates, market surveillance and clinical investigations. Moreover, the database shall provide patients, HCPs (healthcare professionals) and the public with thorough information on medical devices available within the EU. Overall, the establishment of the database shall enable the different actors to be better informed and, thus, make better decisions.

Time frame

During the summer, the proposed regulations were endorsed by the Council’s Permanent Representatives Committee and confirmed by the Parliament’s ENVI committee.

Now, the Council and the EU Parliament shall approve the regulation, which is expected to be done during the fall of this year.

The proposed regulation on medical devices will apply three years after publication (2019) and the proposed regulation on in vitro diagnostic medical devices will apply five years after publication (2021).


DELACOUR’s team of life science specialists follow the development and ratification of the two new EU regulations and will bring updates on the matter ongoing.