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EU Parliament Approves Proposal
- Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager
The future changes include :
1. Extension of the transitional period for certain IVDs depending on their risk classification:
- Class D: 31 December 2027
- Class C: 31 December 2028
- Class B and Class A sterile: 31 December 2029
These new deadlines are contingent upon meeting specific conditions, including contracting with a Notified Body approximately two years before the deadlines and establishing a Quality Management System compliant with the EU IVDR by May 26, 2025, regardless of the device classification. Additionally, devices must be CE marked under the IVD Directive, and there should be no significant changes to their design or intended use.
2. Gradual roll-out of the EUDAMED modules following audits and confirmation of functionality. Contrary to the original proposal which foresaw the mandatory use of Eudamed only when all modules were completed and launched, this phased approach will enable a gradual roll-out of the modules that have been finalized. The mandatory use of the already finalized modules for registration of economic operators, devices, and certificates, currently available for voluntary use, could then start as early as end 2025.
3. Manufacturers will be obligated to notify relevant competent authorities and supply chain stakeholders/customers at least six months in advance of any device supply interruptions that could reasonably result in (risk of) serious harm to patients or public health. This will open an interesting discussion on the interpretation of when the device supply interruption could reasonably result in risk of serious harm to patients or public health.
What does this mean to you?
This amending regulation to extend the transitional period for certain devices provides IVD manufacturers with more time to transition the existing devices from the IVD Directive 98/79/EC to the IVDR 2017/746. Specific conditions will apply for a manufacturer to make use of the transitional provisions, one of these being a deadline by when at the latest your conformity assessment to IVDR must have been submitted to the Notified Body. However, not all aspects are delayed.
Since 26 May 2022, for all devices, including those making use of the extended transitional provisions, the IVDR requirements relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices apply, instead of the corresponding requirements in Directive 98/79/EC. In addition, this amending regulation also introduces the requirement for having an IVDR-compliant quality management system no later than 26 May 2025, regardless of the device classification.
We therefore would like to stress the importance of continuing all your transition efforts and preparing for certification under the IVDR as soon as possible. Do not wait until the end of the transition period because you will find a long waiting list and very scarce availability of notified bodies.
Of final note, the proposal will now proceed to the European Council for final endorsement before being published in the Official Journal of the European Union (OJEU). It will enter into force on the day of its publication.
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