It felt a bit like being stuck in traffic while going on a well-deserved vacation after multiple months (or years) of hard work. Everyone got in the car to brave the Route du Soleil to get to their destination in the south of France. In our case, all manufacturers and Notified Bodies were racing together towards the bottleneck of 26 May 2024 to get as soon as possible all medical devices MDR certified.
As we all know, the Route du Soleil highway is jammed with traffic around Lyon (being May 26 2024) during the summer. The European Commission needed to fix this traffic collapse and published Regulation 2023/607 to extend the transitional provisions of the MDR.
With the MDR extension in place, manufacturers feel there's enough time to reach their destination: MDR certification. Everybody stopped the car and pauses in a parking lot along the highway or even rented a bed and breakfast to really relax for a bit.
Moral of the story
If you just put your car in a parking lot, make sure that everybody steps in again and goes on the empty highway again. Now is your chance to get ahead of the traffic jam or even change your route to come to your goal in the most effective way. With the deadline being postponed and the opportunity to apply for MDR with a substitute device now is the time to jump in the driver’s seat again and put the foot back on the gas to travel ahead of the traffic jam which will come again when everybody finished their break. If you plan properly and act quickly now you might even implement certain significant changes in the submission which beforehand were planned after the CE certificate is obtained. You can perform all necessary tests and (re)validate if required (changed) processes.
If you stay in the bed and breakfast too long or too long in the parking lot others might already be on the road again and jam the traffic at the junctions. So, if you wait too long with applying for the MDR and act accordingly you will be at the end of the line and maybe never reach your destination in time.
Therefore, get back in the driver’s seat, enjoy that fact you had a little break and put your foot back on the gas. If you wait you will be stuck again.