The current European regulatory landscape is undergoing a delicate transition. The introduction of Regulation (EU) 2023/607, which amended the deadlines of the MDR (Medical Device Regulation), has given manufacturers more time to comply with the new rules. However, the practical application of these extensions is highlighting several shortcomings. Many manufacturers of so-called Legacy devices (devices placed on the market under MDD certificates that are still valid or have expired under specific conditions) do not fully meet the requirements necessary to benefit from the transitional regime.

This situation exposes the entire supply chain, from distributors to end users, to significant risks of non-compliance. Without rigorous verification by the parties involved, there is a risk that devices that are no longer legally allowed to be on the market will be placed on the market, with the associated consequences.

THE CONFIRMATION LETTER: AN OBJECTIVE GUARANTEE INSTRUMENT

To mitigate these risks and ensure supply chain continuity, adopting more stringent control procedures has become essential. In this context, the confirmation letter serves as an added value for the acceptance of Legacy Devices.

The Confirmation Letter, which can only be issued by a Notified Body, certifies that:

• The MDR contract between the manufacturer and the Notified Body was signed by September 26, 2024;

• There is an EC declaration of conformity prior to May 26, 2021;

• The official certification application was submitted to a Notified Body by May 26, 2024.

In the absence of these conditions, the extended validity of the old certificates expires, and legacy devices can neither be manufactured nor placed on the market.

STRATEGIES FOR BUSINESS CONTINUITY

Organizations operating in the sector must therefore implement monitoring systems to ensure compliance with the above.