Europe: Deadlines for New EU IVDR Compliance

ARQon
May 6, 2022
1 min read

On 20 December 2021, the European Commission announced that instead of the May 2022 deadline for compliance of the new In Vitro Diagnostic Medical Device Regulation, it will now be progressively rolled out.

The new deadlines mainly affects companies planning to sell registered IVDR in the EU market until the their existing IVDD certification expires, or the IVDR compliance deadline released by the EU Commission, whichever is earlier. However, note that if manufacturer wishes to significantly modify an existing IVDD device after May 2022, it must be certified to the IVDR.

Below is a table summarizing the new deadlines for corresponding device classes.

IVDR Classification	Full IVDR Compliance Deadline for Existing IVD Devices Currently in Compliance with the IVDD	Deadline to Comply with IVDR Postmarket Surveillance, Economic Operator, and Device Registration Requirements
Class A IVD (nonsterile)	26 May 2022	26 May 2022 (All products)
Class A IVD (sterile)	26 May 2027	26 May 2022 (All products)
Class B IVD	26 May 2027	26 May 2022 (All products)
Class C IVD	26 May 2026	26 May 2022 (All products)
Class D IVD	26 May 2025	26 May 2022 (All products)
Existing IVDD CE certificate products	26 May 2025	26 May 2022 (All products)

Note that although Class A IVD (nonsterile) do not require Notified Bodies to be involved and hence have an earlier deadline, the devices may still have to comply provisions of the IVDR.

For the rest of the device types, the deadlines above only apply if the device is under IVDD before 27 May 2022. As mentioned above, significant changes to the product or its intended use may require IVDR certification.

In addition, devices that are manufactured and used in the same health institution (in-house devices) have been given a deadline extension till May 2024. If the manufacturer can prove that an equivalent device is not available in the EU market, it is further pushed back to May 2028.

Source

Progressive roll-out of the In Vitro Diagnostic Medical Devices Regulation