MDR – Some Class I Device Transitions Extended

03 February 2020 |

Deadline extended

Under growing pressure from industry and notified bodies, the need to provide some breathing space around Medical Device Regulation (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.

If you have questions about how to navigate the use of standards and managing test programs, please reach out. We have a staff of consultants with extensive expertise. Whether it’s a TGA application, a strategy for MDR transition, a US presubmission or 510(k) filing, or specific help with regulatory documents (e.g. Clinical Evaluation Reports), or an update of your quality system to gain MDSAP. We understand you need a commercial approach which delivers viable options. 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) ♦ +61 2 9906 2984 (Sydney)

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