Europe: Partial Postponement of European IVDR Application Europe

ARQon
Dec 17, 2021
2 min read

The European Commission has proposed to postpone the In-vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR), which would give more time for some manufacturers to prepare for compliance to the new Regulation and secure Notified Body support.

IVDD to IVDR

The initial implementation date of IVDR was planned on 26 May 2022. Two major changes are there would be change in risk classification and requirements health institutions for manufacturing ”In-house” IVD tests.

Challenges to implementation

In order to implement the IVDR, a critical infrastructure is required:

Notified Bodies need to be available for auditing and reviewing documentation;
Expert panels need to be able to provide their opinions;
Reference laboratories must be available for testing the performance claimed by the manufacturers;
The Eudamed database should be available for health institutions to justify why they consider a commercial test not being placed on the market.

Due to these challenges, European Commission has proposed to delay the IVDR implementation. This proposal has been explained & justified in separate documents. Date of application The proposal specifies that the IVDR application date will remains on 26 May 2022. As a result, IVDs that are classed as Class A, self-certified, under the IVDR must comply by May of the following year. Other devices have staggered arrangements under the European Medical Devices Regulation (MDR), similar to legacy devices:

The validity of certificates issued under the IVDD will last until 27 May 2025. For IVDs currently on List A or List B, or for self-testing under the IVDD, this would require an extra year.
IVDs that can self-certify or self-test under the IVDD but need Notified Body certification under the IVDR will have extra time:
26 May 2022 for Class A, self-certified – sell-off period until 26 May 2025
26 May 2025 for Class D – sell-off period until 26 May 2026
26 May 2026 for Class C – sell-off period until 26 May 2027
26 May 2027 for Class B – sell-off period until 26 May 2028
26 May 2027 for Class A, sterile – sell-off period until 26 May 2028
Except for the rationale of 5(5)(d), which is postponed until May 26, 2028, the applicability of most standards for health institutions doing in-house manufacturing (see Article 5(5)) would be postponed until May 26, 2024 (two years).

These "legacy devices" will, however, be subject to IVDR regulations for post-market surveillance (PMS), market surveillance, vigilance, and registration of economic operators. This is similar to the MDR's criteria for legacy devices.

The Proposal will now go to the European Parliament and Council for adoption.

Sources:

Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL; amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and deferred application of requirements for in-house devices

Questions and Answers on the progressive roll-out of the new In Vitro Diagnostic Medical Devices Regulation

Public health: Commission proposes a progressive roll-out of the new In Vitro Diagnostic Medical Devices Regulation