Some Class I Device Transitions Extended – MDR
Under growing pressure from industry and notified bodies, the need to provide some breathing space around MDR deadlines by the European Commission has finally been considered.
After much focus on the new Medical Device Regulation (MDR), specifically on higher risk devices, it is now becoming evident that some of the applied changes impacting lower risk devices will have greater effect on the workload of both industry and notified bodies. A specific case is the creation of the Class I reusable medical devices.
Under the new Medical Device Regulation, some medical devices previously defined under the MDD as Class I and self-declared, will now have an increased level of review by the notified bodies. This has for some time flown under the radar while everyone focused on the higher risk devices, also while the notified bodies also get up to speed on their specific requirements.
Late 2019 saw the Council of the European Union consider the extension on the timelines for a specific group of Class I devices, namely those that fall into the Class I reusable category (but also others including software etc). With the proposed extension, the timelines for these products pushes out to May 2024, however there are a number of conditions that manufacturers need to understand.
These are specifically around the date of the DOC being issued under the existing MDD, prior to the May 2020 implementation. This is obviously ensuring that no significant updates are made to the product prior to being reviewed under the MDR.
In addition to the above is the expectations of the manufacturers to implement specific MDR requirements, including the updated post market surveillance for these types of devices.
If you’re unsure of your requirements, your classification or the new updates under the MDR, reach out to us for a no obligation to gain a better understanding, or sign up to our upcoming webinar on Post Market.
Need to navigate expedited or Emergency regulatory pathways? We are experienced in dealing directly with regulatory authorities and can offer rapid support. Contact us to discuss your needs and how we can help. You can drop us an email [email protected] or call 1 888-271-5063 (US toll free) ♦ 400-842 7017 (Beijing – toll free) ♦ +61 2 9906 2984 (Sydney)
The views and options expressed in this article are those of the author/s and do not necessarily reflect the views of Brandwood CKC Pty Ltd ACN 128 762 505.
The information presented in this article is of a general nature only and does not consider the particular circumstances of your business. Prior results and case studies do not guarantee a similar outcome in future. You should not rely on this information, and you should seek specific advice for your particular business needs.
Where indicated, certain content has been sourced from third parties; we have not independently verified it. Neither Brandwood CKC nor the author makes any warranty as to the accuracy, completeness or reliability of this article, nor do those parties accept any liability or responsibility arising in any way from omissions or errors contained in the content.