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.
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