Regulatory Update - IVDR Implementation Amendment

EU Commission’s proposed amendment to transition period of the In Vitro Diagnostic Devices Regulation (IVDR) calls for a progressive roll out

The current 26 May 2022 timeline for IVDR implementation has been greatly impacted by the fact there are only six notified bodies designated under the Regulation and all have been under great pressure. Additionally, COVID-19 has impacted in many ways including diverting resources towards addressing the crisis and therefore eating into time for regulatory review of compliance.

And so, the Commission has put forward the proposal that higher risk devices have an extended transition period until May 2025 (Class D) and 2026 (Class C), with lower risk IVDs such as Class B and A sterile devices now having a transition period through to May 2027. No change is proposed for CE-marked devices that do not require notified body involvement under the IVD Regulation or for devices that are ‘new', i.e., devices that have neither a notified body certificate nor a declaration of conformity under the current Directive 98/79/EC. For those types of devices, the IVDR will therefore apply from 26 May 2022 as planned.

There are no changes proposed to the Regulation itself, only to the transitional arrangements to allow a progressive roll out.

This is a proposal only towards legislation and will require agreement from all EU institutions. The Proposal will now go to the European Parliament and Council for adoption. Read the press release here.