Ovid already wrote over 2000 years ago, "Good things come to those who wait." Sometimes it is also said, "Good things come to those who wait." And then there is the quote, "Everything has an end, only the sausage has two." What all these quotes have in common is that it takes time for something new to emerge and that the world is constantly changing. Today, Wednesday, May 26, 2021, we notice this as the transition period for the MDD (93/42/EEC) and the AIMD (90/385/EEC) ends. The Medical Device Regulation (EU) 2017/745, or MDR for short, now applies! The MDR was published on May 5, 2017, and came into force on May 25, 2017. Many uncertainties and teething problems accompanied and continue to accompany the launch of the new EU regulation. Medical device manufacturers and notified bodies began an intensive period of preparation for the MDR. The transition period was supposed to end last year, but due to the coronavirus situation, everything was postponed for another year. But now the time has come, and in case you haven't noticed: What takes a long time finally comes to MDR.
If you still have a medical device based on an MDD certificate, you can still place it on the market until the certificate expires, but no later than 2024. Then this transition period will also end, and the MDD will finally be history.
But even the good old Medical Devices Act (MPG) is being replaced today by the new Medical Devices Implementation Act (MPDG). The MPG implemented the requirements of the EU Directive (MDD) into national law. This isn't necessary for the MDR and IVDR, as they are an EU regulation and thus already have the character of a law. Nevertheless, there are national specifics that are contained in the MPDG. The law can be found online as a PDF here: MPDG.
The MDR brings a host of new developments and challenges for medical device manufacturers. Many medical devices, especially software products (e.g., medical apps), that were previously Class I devices, are now Class II or Class III devices, requiring testing by notified bodies. Unfortunately, the number of notified bodies has decreased significantly due to the transition to the MDR. Therefore, the coming months will be exciting, and it remains to be seen how manufacturers and notified bodies manage the transition from the MDD to the MDR.
With the entry into force of the MDR today, Switzerland becomes a third country, as mutual recognition of conformity assessment procedures (Mutual Recognition Agreement) has not yet been achieved. This is not good news, especially for Swiss medical technology companies.
Nevertheless, we want to look forward to the MDR with confidence and anticipation, and to continuing to develop safe and effective medical devices that help people. The MDR launch will certainly bring a few hiccups and minor problems here and there, but little by little, everything will settle down. We wish all medical device manufacturers much success and every success.
Best regards
Goran Madzar