The transition to ISO 13485:2016 must be completed.
MDR goes into effect.
EC Certificates of Conformity issued before May 27, 2017 expire.
MDD certified devices already in the market may be available. New devices must be MDR certified.
MDD certified devices can no longer be sold or distributed.
Medical device companies will see most changes in the following areas when the EU MDR goes into effect.
A strong, proactive post-market surveillance system will be needed to collect data on clinical performance and address issues. PMS must be proactive, not just reactive. Serious incidents must be reported in 15 days instead of 30.
A post-market clinical follow-up (PCMF) plan and a Periodic Safety Update Report (PSUR) will be required. The finding of the PCMF should be a main component of the PSUR.
All reprocessors will be held to the same standards and regulations as device.
The new regulation around medical devices will strengthen the controls around traceability and transparency within the whole supply chain.
There will be significant requirements for labeling, including having a UDI registered with EUDAMED. The UDI will need to be implemented and differences between the FDA and EU classification taken into consideration for products on the market globally.
Up-classified products will need more significant Notified Body review. New classification rules will determine the correct class of software and which devices incorporate nanotechnology.
The review of technical files and design dossiers by Notified Bodies may also result in more comments that must be addressed before the reviews are completed.
All medical device companies will need a Person Responsible for Regulator Compliance (PRRC). There will be no grandfathering in of products and most legacy devices will need updated robust clinical evaluations and data.
Scientific literature used for equivalence will need to include more clinical trials. Additional clinical evidence will also be required for products already on the market.
Medical device manufacturers will need to be able to provide sufficient coverage for their product liability.
Two years ago when the announcement was first made to publish the new regulations. Call us today for help because you need it.
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If you market your device in the European Union (EU) pursuant to MDD, keep in mind there is no grandfathering of devices under the MDR. Additionally, your device classification also might have changed and may now require clinical evaluation and revamping of the tech file.
Devices placed on the market before May 2020 under the MDD and even after May 2020 can remain on the market until May 2025. But, this timeline depends on when you received your MDD certificate.
The new EU Medical Device Regulation has extended the scope of EU MDR applicability. Some products which were earlier not considered to be a medical device are now under the jurisdiction of the medical device regulations. Newly added products include:
First, don’t panic. We know that the EU is a big market for any medical device manufacturer and losing that revenue would have a negative impact on your business. We recommend starting by conducting a gap analysis of your current quality system and documentation. Contact us immediately. Our team of EU MDR experts will help you strategize your next steps.
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