Proposal for new IVDR Extension and Software

The European Commission published a long-waiting proposal to extend the transition period for legacy devices under IVDR. Around 80% of IVDs are subject to scrutiny by notified bodies, most of them for the first time. According to the commission, the vast majority of IVDs have not yet transitioned to the IVDR.

The In-Vitro Diagnostic Regulation, already in 2022, received a staggered extension of its transitional period, ranging from 26 May 2025 for high-risk IVDs to 26 May 2027 for lower-risk IVDs, and to 26 May 2028 for certain provisions concerning devices manufactured and used in health institutions. However, the slow rate of transition made this extension insufficient.

Therefore, the new proposal aims to further extend the transitional period applicable to legacy devices, i.e. those covered by a certificate or declaration of conformity issued under Directive 98/79/EC before 26 May 2022.

Extended IVDR compliance dates:

Concerning software, the proposal applies to legacy medical device IVD software, which requires a Notified Body, under IVDR, to assess the conformity of the product before being placed on the market.

Read REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL