What is changing?
Given the impact that medical devices can have on people’s health and lives, it is not surprising that the medical devices themselves, as well as their use and application, are strictly regulated. To this end, the European legislator has formulated a regulation, the Medical Device Regulation (MDR). This regulation has been in force since May 26, 2017 and will come into effect on May 26, 2021 and will then replace the current European directives.
The MDR is an extension and tightening of the existing rules. The consequence of this is, among other things, that medical devices will more often fall into a higher risk class than was the case under the Directives and that more devices will be classified as medical devices within the meaning of the Regulation. Notable examples of this are software, electronic patient records and apps that are health-related.
The tightened risk classification means that market participants often have to comply with more extensive obligations than was the case under the directives.
In addition, the MDR entails a new supervisory arrangement based on the accountability principle. Economic operators are expected to be able to demonstrate at all times that they comply with the Regulation and that they have taken measures to that end that are working.
What do you have to do?
First of all, the MDR requires market participants and medical devices to comply with legislation and regulations, including the regulation itself. This requirement applies throughout the entire life cycle of the medical devices. A first step towards compliance is an inventory of the tools used. If it follows from this that there are medical devices as referred to in the MDR, further actions, including qualification, registration and documentation, will have to be carried out. Compliance also requires policy measures.
What can First Lawyers do for you?
First Lawyers can provide legal support in preparing to be demonstrably compliant and accountable. Specific points of attention are:
- The legal qualification of aids;
- Drawing up a declaration of conformity;
- Making a risk inventory of liabilities in order to meet the requirement of sufficient financial coverage;
- The registration in the UDI register, and in Eudamed; and
- Drafting contracts and supporting contract negotiations, as well as conducting contract management.
In addition, First Lawyers can assist you if you as a market participant or user have to deal with a regulator and you need legal support.
If you have any questions or would like to know more about MDR, please contact us on +31 (0) 70 306 00 33 or firstname.lastname@example.org.