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EU MDR`s impact on legacy medical devices
Medical Devices Regulation (MDR) completely changes the legislation and business processes regarding the production and distribution of medical devices. We have already considered the topic of MDR`s changes and requirements, but not the impact on the legacy medical devices.
In this article, you can get acquainted with the topic, but first – let’s clarify what “legacy medical devices” means. A legacy device is a medical/implantable/in vitro diagnostic device, which is already on the market with a valid certificate from Medical Device Directive (MDD) or Active Implantable Medical Device (AIMD). However, these legacy devices must be brought into compliance with the MDR, per timelines set out in the transitional provisions of the new regulation.
How devices with MDD certification will be “treated” according to MDR?
Devices, which were legally placed on the market before 26th of May (MDR) and after this date with a valid MDD/AIMDD EU certificate, could be available on the market under certain conditions according to MDR. First, the devices must follow and comply with the state-of-the-art requirements and be without significant changes in their design. Moreover, the different registration requirements for the product (in respect of the economic operator) must be considered, as well as post-market tracking requirements and post-market surveillance requirements (Article 120).
It should be made clear that the fact they can remain on the market with a valid MDD certificate or CE mark, does not mean that the manufacturers of this type of device completely “bend” the MDR. No, they are just saving time. For example, legacy devices Class I – yes, these devices could be on the market, but their manufacturer must “reconstruct” his processes (labeling/surveillance/post-surveillance) according to the new regulation. Don`t forget the documentation – in order to ensure full compliance with MDR policy, manufacturers must develop post-market surveillance plans/reports, trending reports, Post-market clinical follow-up reports, market vigilance records.
Legacy devices and EUDAMED
EUDAMED is inevitably one of the major changes to the MDR. The centralized data storage portal for medical devices` information will strengthen market surveillance and help ensure clear visibility and transparency. Detailed information about EUDAMED
However, the registration in EUDAMED requires the provision of Basic-UDI (basic device identifier) and UDI-DI (device identifier and manufacturer) – UDI regulation. However, for legacy devices are required their equivalents:
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- instead of Basic – UDI – EUDAMED-DI (assigned by the manufacturer or EUDAMED)
- instead of UDI-DI – EUDAMED ID (generated by EUDAMED)
EUDAMED is not fully operative and the compliance with UDI system is already required for class III devices. It will become compulsory for class IIa and IIb devices in 2023, and for class I devices in 2025.
Recommendations
As we like to advise “Be informed – be prepared!”. The expiration date of MDD certificates is the 26th of May, 2024. As a manufacturer, you have four years to comply with MDR requirements. It is recommended to analyze your practices and to fill the gaps. Create a plan and strategy, including new post-market surveillance, market surveillance, vigilance, and device registration requirements.
Adapting and complying with a new regulatory model is never a simple process – our experts are always “on-board” – schedule a free meeting with our experts >>
Sources:
https://ec.europa.eu/health/sites/default/files/md_eudamed/docs/legacy_dvc_management_en.pdf
https://medinstitute.com/blog//exploring-the-eu-mdrs-impact-on-legacy-medical-devices/