January 23, 2024
The European Commission (EC) has announced a proposal to delay compliance of legacy devices to the In Vitro Diagnostic Medical Devices Regulation (IVDR), and for EUDAMED to be rolled-out by modules completed.
The EC Press Release heralds this as a proposal to “ensure the availability of IVDs” and enhance the “transparency on medical devices.” An accompanying Questions and Answers document explains many of the reasons for the proposed delay, and provides background information, as does the proposal itself.
Extended IVDR compliance timeframes for legacy IVDs
Legacy device manufacturers, by definition, placed the devices on the EU market before the IVDR Date of Application (26 May 26, 2022). The EC now proposes the following transition timeframes for legacy IVDs are as follows:
- Legacy IVDs Class D (IVDR) must be compliant by December 2027.
- Legacy IVDs Class C (IVDR) must be compliant by December 2028.
- Legacy IVDs Class B and Class A sterile (IVDR) must be compliant by December 2029.
What about EUDAMED?
The EC has also proposed advancing implementation of EUDAMED modules as soon as they have been audited and declared as functional. This is expected to require several EUDAMED modules at the end of 2025.
As part of the typical European legislative process, the proposal will now be advanced for review and approval by the European Parliament and Council for adoption.
The additional time for legacy IVDs is likely welcomed by industry, as progress with compliance to the IVDR and the designation of notified bodies to the IVDR has been slow. Proposed use of EUDAMED as soon as feasible is a development seen by all as necessary for medical device data to be available in the EU.
Both of these proposals are likely welcomed by much of industry.
Emergo by UL will provide more in-depth analysis of the EC proposal in the near future.
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