The European Union Medical Device Regulation (EU MDR) (2017/745) was approved by the European Parliament on May 25, 2017. This new medical device change recognizes historical medical device problems and aims to strengthen regulatory requirements and oversight to foster a more FDA-like regulatory environment. The mandatory deadline for compliance is fast-approaching...don't miss it!
One of the biggest impacts of EU MDR will be to manufacturers with existing products on the market. There will be a new MDR requirement for clinical evidence specific to every product. Past use of data from similar products and published data from competitor products will be extremely limited and possibly not accepted at all. This portion of the change will apply to existing and currently-approved products after the change transition period. Additionally, historical market data and complaint/vigilance data will not be accepted in lieu of a true clinical study.
If product-specific evidence through an appropriate clinical study is deemed insufficient, the product’s certificate will most likely not be renewed. Therefore, it’s vital that manufacturers assess their currently-marketed products and select those that will be marketed after the transition period in order to initiate the required clinical studies as soon as possible.
Additionally, manufacturers must remove all products that will be orphaned at the end of the transition period from the market as soon as their certificates expire.
New or modified labeling will be required for all marketed products, including product packaging labels and instructions. Product claims and clinical evidence from the newly required studies will also have to be included.
EU MDR will also strengthen post-market surveillance requirements for:
While all medical device companies have until 2020 to comply with the EU MDR, it’s important to start the implementation process now in order to have enough time to generate sufficient clinical evidence and adhere to the other required changes for your marketed products. Do not make the mistake of under-estimating the time and effort needed to comply with this new regulation by the mandatory deadline. Get started by reviewing PRP's High-Level Overview of Tactical Steps.
We are currently offering a Free 30 Minute Consultation to help you navigate EU MDR. To schedule your Free 30 Minute Consultation, just fill out the form, and one of our team members will be in touch to set up your meeting.
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Let PRP provide the guidance you need on what to expect. Our subject matter experts can help you navigate these changes by sharing how other medical device companies are approaching these challenges. To schedule your Free 30 Minute Consultation, just fill out the form. One of our Client Service Managers will be in touch to schedule a 10-minute call to discuss how we are helping our clients with these issues as well as to set up your 30 Minute Consultation.
Don’t wait to schedule your Free 30 Minute Consultation!