EU Commission proposal as regards transitional provisions for certain IVDs
[Contenuto in lingua inglese]
On 23 January 2024, the European Commission released a proposal regarding the transitional provisions for certain legacy in vitro diagnostic medical devices by providing manufacturers and notified bodies with additional time, under certain conditions, to complete applications and necessary conformity assessment procedures.
The Commission is also proposing measures to enable a gradual roll-out of EUDAMED modules already available for voluntary use, instead of deferring the mandatory use of the database until the final module is completed.
The proposal places also a new requirement for manufacturers to provide prior notice to competent authorities, relevant economic operators, and healthcare professionals/institutions in case of disruption of supply of certain medical devices and in vitro diagnostics.
With this proposal, the Commission aims to ensure patient care by improving the availability of these essential healthcare products, without compromising safety requirements. This proposal is a response to recent figures showing that a high number of IVDs currently on the market have not yet managed to transition to the IVDR ((EU) 2017/746), meaning that those devices would no longer be available by the end of current transition timelines if these are maintained.
The proposed IVDR transition periods for devices self-declared under the IVDD, now requiring Notified Body certification under the IVDR, will depend on device classification:
- 31 December 2027 for Class D self-declared devices
- 31 December 2028 for Class C self-declared devices
- 31 December 2029 for Class B and A sterile devices
Legacy devices, meaning devices covered by IVD Directive (98/79/EC) certificates, may also benefit from an extended transition period until 31 December 2027 if they meet the conditions laid down in the Amending Regulation, one of which being submitting an IVDR application to the Notified Body by the 26 May 2025.
The Commission has also proposed postponing to 26 May 2030 the application of one of the requirements for devices manufactured and used in health institutions (i.e., the requirement to show that there is no alternative and equivalent commercial device on the market).
Please note, this is still a proposal and is not to be considered official until is published in the Official Journal of the European Commission (OJEU). Current IVDR timelines are to be considered still effective and are sensitive to the upcoming proposal implementation. We are committed to keeping you informed on further developments to facilitate your understanding and transition process to the IVDR and to the amended timelines.
For additional information, BSI Regulatory Services encourage you to consult the following resources:
European Commission Press Release
Sincerely,
Alex Laan
Head of IVD Notified Body
Regulatory Services, BSI
