Last month the date of application of the Medical Devices Regulation 2017/745 (MDR) was postponed to May 2021, i.e. one year later. Although it is a fact that this delay will release some pressure for the time being for all the actors of the medical device sector, companies should not relax thinking that one year is a lot of time to be prepared (A year will go by quickly!), but they should keep pushing for the MDR readiness as if the date had not changed, because the final deadline for all devices remains unchanged in May 2024 and it is very questionable that companies will manage those timelines.
Use the Additional Time to Work with or Look for Your Notified Body
Only 14 Notified Body (NB) are currently designated to operate under the MDR and there is no reason to assume that NB availability and capacity will improve too much with the extended deadline. The new requirements of the MDR for the NBs mean more resources and involvement when certifying a product, therefore NB will not be able to accomplish all technical documentation and QMS assessments within the last seconds of a transition period for the MDR. So, if you are thinking of update your Medical Device Directive 93/42/CE (MDD) certificate to MDR or if you want to certify a new product under the MDR hurry up!
If you already have an existing MDD CE certificate set to expire soon, you (and your NB) may have some extra time to get it renewed it and to make it valid until May 2024. This situation is the same if you still want to place a new product on the market under the MDD since you have one more year to do it. However, be aware that many NBs stopped accepting devices seeking renewal MDD certificates months ago or even with the new postponement they have fixed a deadline to accept MDD certification process (SGS, for instance, stated that the complete technical files must be sent before November 2020), so before start spreading the good news, call your NB to see if they are accepting MDD renewals and, if so, until when. If they are, don’t expect your window of opportunity to be open all the way until May 2021.
Remember, the sooner you are prepared for your audit, the faster you’ll be able to respond to NB availability and put the transition milestone behind you.
Issues to bear in mind when choosing the best option
If you are thinking on option 1 because the MDD certification of renewal will be easier than a new MDR certificate, it is totally logical since is a way to maximize the life of an MDD device which has no sense to pursue under the MDR, but please again be aware that if you are pondering making any changes to your device before 2024, be sure that it not is considered a significant change (Art. 120 of MDR), because products with a valid MDD certificate can continue to be marketed after the EU MDR Date of Application, as long as there are no significant changes applied to the device. Examples of what is considered a significant change are: Changes to the purpose/destination of a medical device, design changes (components or materials, method of sterilization or conditioning necessary to preserve the sterile condition, software changes), etc.
But even if you accept not to change your device at all until 2024, there are many requirements of the MDR that you must comply although you have a valid MDD certificate:
– Post-market surveillance plans & reports updated
– Periodic safety update report:
– Post-market clinical follow-up plan & report.
– Update retention times for documentation
– Update vigilance reporting times
– Basic UDI-DI, UDI-DI & UDI-PI.
Speaking of clinical data, now there is an extra year for you to obtain additional clinical data and conduct your company’s EU MDR audit, therefore if you are among the many medical devices companies wondering if your clinical evaluation report has sufficient evidence to withstand NB scrutiny, you now have more time to have everything in order. This is important for class III and implantable products since no clinical equivalence with other devices will be accepted unless you have an agreement with the manufacturer of the device you want to claim equivalence with.
Keep pushing toward MDR!
Don’t assume that because the MDR has been delayed by one year, MDR authorized NBs will come back auditing to the MDD. Most NBs have already made the switch, and thus you should continue to work on EU MDR compliance as if nothing has changed. Companies that were ahead of the game can continue to distance themselves from the competition and ensure a smooth transition going into 2021. So now you have a golden opportunity to recover time and be on the way.
Let’s ZURKO regulatory team to help you
ZURKO Research team is ready to help you keep marching forward in a variety of ways. We can help you to choose the best strategy to place or to maintain your medical devices on market, starting for the very beginning for new products and/or determining the gaps in your compliance for already legacy devices, assisting you, not only from the regulatory side but also for the preclinical and clinical testing.
Contact our representative for more information! Juan Ángel Gracia firstname.lastname@example.org