Legacy Devices

Alberto Ragusa

Registered
Hi!!
I have a question regarding the legacy medical devices.

What happens to a legacy device put into the market with a valid MDD certificate if this expires before 2024? can it continue to be put into service until 2024/5?

Best Regards,
Alberto
 

TorstenKn

Registered
Dear Alberto,

The legacy device can be placed on the market as long as the certificate is not expired (but not later than 27 May 2024). (see Article 120(2))
An device lawfully placed on the market (within this certificate validity period) may continue to be made available on the market or put into service until 26 May 2025 (see Article 120(4)).

A prerequisite is the compliance with the requirements of the MDR relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices.

Note: That does not apply to certificates as per Annex 4 to Directive 90/385/EEC or Annex IV to Directive 93/42/EEC (which become void at the latest on 27 May 2022).

Best regards,
Torsten
 
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