May 2020 is round the corner and therefore, only a few months remain for date of application (DoA) of the new medical device regulation (MDR).
This new legal framework sets out many new requirements for the medical devices (MD) industry, and it is yet unclear whether there will be any additional delays in the date of applicability for specific requirements other than registrations and upload of relevant device documentation to EUDAMED (postponed to 2022), or the recently published proposed change with regards to a grace period for Class I Medical devices upclassified under MDR (to be extended until May 2024).
Anyhow, medical device manufacturers should have defined an action plan for MDR adaptation long ago, but if not, it is highly advisable to make the most of this remaining transitional time until DoA to become prepared. In this sense, two main alternative strategies are being considered, depending on each particular case:
- re-certifying medical devices under the MDD to extend the validity of the CE certificates (more and more difficult, nearly impossible at this time unless previously agreed with the notified body – NB)
- planning a recertification under MDR with a NB either already redesignated or soon to become redesignated
These alternatives are not devoid of hurdles and inconveniences, including the limited time until DoA, the limited number of available NB under MDR, etc. Therefore, MD manufacturers should optimize time and resources.
Beyond generally recommended precautionary measures such as scheduling increased production of device units under the sell-off transitional provisions, MD manufacturers should proactively be conducting a number of actions, including:
- review of agreements with the supply chain where it shall be clearly specified who does what as well as the robustness of the post-market surveillance system to ensure being on the safe side with regards to product liability;
- review of consistency across the device’s technical documentation with regards to intended purpose and performance claims and risks;
- review of clinical data supporting the risk/benefit profile of the device and of justification of equivalence to other devices, availability of a post-market clinical follow-up plan and eventual update of the clinical evaluation report;
- assessment of potential up-classifications of the devices as per new MDR classification rules and identifying new requirements for CE certification for certain specific device categories, including additional procedural aspects such as scientific opinions from competent authorities and scrutiny of clinical evaluations by expert panels;
- etc.
If you need help in understanding all these new requirements, and in defining and/or executing your MDR adaptation action plan to MDR do not hesitate in contacting us at info@asphlaion.com.
We are here to help you!
