EU Lawmakers Set to Begin Negotiations on Medical Device Regulations


Published Date : Sep 25, 2015

The Council of Ministers in a statement confirmed that its Luxembourg presidency has been given the mandate to begin trilogue talks with the European Commission and the European Parliament regarding the new planned In Vitro Medical Devices Regulations and the Medical Devices Regulations. 

The Council said that the primary goal of the two draft regulations is to make certain that medical devices are of high quality and are safe. This could only be achieved if the rules on positioning devices in the market are strengthened and once available, their surveillance is tightened. 

Lydia Mutsch, the minister for health in Luxembourg said that the European Parliament and the Council go after the same goals regarding the issue of reformation of the medical device sector. Both the European Parliament and the Council need to vote in approval of the new EU regulations for them to be brought into force.

The objectives, Lydia said, are to put in efforts towards developing a strong legal framework that will give patients access to high quality and safe medical devices and at the same time develop conditions that are necessary for an innovative as well as competitive EU market. 

Based on the proposals of the Council, physical instruments, appliances, apparatus, and implants as well as software come under the category of medical device and are therefore subject to performance and safety requirements when the intention is for them to be utilized in any specified medical purpose. These purposes comprise disease diagnosis, monitoring, prevention, alleviation, or treatment. This could also pertain to disability or injuries. In addition, purposes could include replacement, investigation, or modification of a pathological or physiological state or process or of the anatomy. 

However, the Council proposes that the apps that come under “well-being” need not be considered under the regime of medical devices.