The Medical Device Regulation (MDR) has now entered into force and will apply from May 2021. Since this is a regulation and not a directive it will be part of the local regulation in all member states.
The transition to MDR will be challenging for all involved. It demands comprehensive work by industry, Notified Bodies (NB), and the European Commission. In addition to the regulation, the commission and the Medical Device Coordination Group (MDCG) will establish new guidelines in order to help industry interpret the regulation. Also, the Notified Bodies that have decided to be operative under the regulation need to apply for designation. (Read more about the designation process and other changing elements further down.)
At the time of writing, the date for implementation is a little more than a year away. If you haven’t started your transition yet, this should now be your highest priority!
There are 2 available strategies to ensure compliance with MDR in time.
- Stand first in line for MDR application with your Notified Body.
- Last-minute renewal of your CE Mark in compliance with MDD. This is a possible route to take in order to win you some time. However, make sure that your transition process is in motion! Also note that application windows for MDD recertifications are about to close. Some NBs have set a final date at the end of Q1, 2019.
Below is a list of the top changes that will apply from May 2020.*