Exploring the EU MDR’s Impact on ‘Legacy’ Medical Devices

Devices already legally on the market under the European Union’s (EU) Medical Devices Directive (MDD) or the Active Implantable Medical Devices Directive (AIMDD) are referred to as ‘legacy devices’. Under the EU MDD, some devices were exempt from meeting the new directive and allowed continued access to the market, a mechanism commonly referred to as ‘grandfathering’. In the US, the FDA recognizes ‘pre-amendment devices’ which are devices legally marketed in the US by a company before May 28, 1976 and which have not been significantly changed or modified since then and for which a regulation requiring a PMA application has not been published by the FDA. Devices meeting these criteria are ‘grandfathered’ devices and do not require a 510(k). Devices are not grandfathered under the EU MDR; the new regulation requires recertification of all medical devices, many of which are re-classified under the new regulation.

The EU MDR began a transition period in May 2017. Devices lawfully placed on the market pursuant to the Directives prior to the date of EU MDR application (May 26, 2021), and devices placed on the market from May 26, 2021 onward may continue to be made available on the market until May 27, 2025 under a valid MDD/AIMDD EC certificate if the following EU MDR transitional provisions are met:

• There can be no ‘substantial’ design changes made to the device.
• Devices must remain in compliance to state-of-the-art requirements. This includes compliance with any general regulation as well as any device-specific technical standard.
• New MDR post-market surveillance requirements must be implemented along with requirements for post-market clinical follow-up (or justification why post-market clinical follow-up is not required).
• Various registration requirements for all economic operators must be completed.

The loss of grandfather rights could mean that your legacy device needs evidence of performance and safety as part of a lifecycle approach to clinical evidence. The clinical evidence required for market access under the EU MDR for legacy devices should preferably be created while the device still has a valid MDD/AIMDD EC certificate. Historically, legacy devices may have been allowed to remain on the market for long periods without intentional scrutiny to ensure they were still safe and effective, as long as there were no serious incidents. The new EU MDR brings more focus to risk management and post-market surveillance.

Managing the transition from the EU Directives to the EU MDR requires a lot of work; MED can help. If you want to know more, get in touch with our team of regulatory, scientific communications, and quality experts at medinstitute.com or contact us at 855.463.1633.