On 9 July 2024, the new Regulation (EU) 2024/1860 amending the medical devices Regulations (MDR and IVDR) was published in the Official Journal of the EU. With this publication, the new extended legacy period for IVDs officially applies from 9 July 2024, together with other measures.
Legacy IVDs: Longer Transitional Provisions
The new legacy provisions foresee that IVDs meeting legacy requirements can be placed on the market until the following dates:
- Class D and IVDD CE-Certified Devices: 31 December 2027
- Class C: 31 December 2028
- Class B and Class A Sterile Devices: 31 December 2029
Conditions for Eligibility
- Notified Body Application Deadlines:
- Class D: 26 May 2025
- Class C: 26 May 2026
- Class B & Class A Sterile: 26 May 2027
- Quality Management System (QMS):
- A QMS compliant with IVDR requirements must be in place by 26 May 2025.
- IVDD Certificate Validity:
- Devices covered by an IVDD certificate must have a valid certificate on 9 July 2024.
- Expired certificates may still qualify if a notified body agreement was signed before expiry, or national derogation measures allow it.
Quality Management System (QMS) Requirements
A Quality Management System (QMS) documents processes and responsibilities for achieving quality policies and objectives. Under the MDR and IVDR as well as according to the legacy requirements for IVDD compliant devices, manufacturers of medical devices must have a QMS compliant with the Regulations to sell in the EU, whether they are based in the EU or not.
Obelis offers different services to support manufacturers of medical devices and IVDs with the implementation of a compliant QMS, such as ISO 13485 trainings, templates and gap analysis, implementation meetings, and audit simulations with our experts.
Applying with a Notified Body
In the transition from the Directives to the MDR and IVDR, many devices were upper-classified, requiring the intervention of a notified body for their conformity assessment under the Regulations. Notified bodies usually only assess some types of devices under the IVDR or MDR and do not have the full designation scope under MDR or IVDR. With knowledge and network in the field, Obelis helps manufacturers to find the right notified body.
Other Changes Under Regulation (EU) 2024/1860
Together with extended legacy provisions, Regulation (EU) 2024/1860 brought significant changes in the EUDAMED implementation and supply interruption notification obligations.
EUDAMED will be implemented gradually, with the first modules for actor and device registrations expected to be mandatory in 2026. Concerning the new notification obligations, manufacturers of both medical devices and IVDs must inform the relevant competent authority and health institutions at least 6 months before they stop, either temporarily or permanently, to supply a critical device.
Do you have questions on how to be eligible for the new legacy period?
FAQ
- What is the IVDR legacy period?
The legacy period allows certain IVDs to remain on the EU market while transitioning from IVDD to full IVDR compliance.
- Which devices are eligible for the extended legacy period?
- Class D and IVDD CE-certified devices: until 31 Dec 2027
- Class C devices: until 31 Dec 2028
- Class B and Class A sterile devices: until 31 Dec 2029
- What conditions must be met to benefit from the legacy period?
- Submission of a Notified Body application by the set deadlines
- Implementation of an IVDR-compliant QMS by 26 May 2025
- Valid IVDD certificate on 9 July 2024 or prior NB agreement/national derogation
- What is a QMS and why is it important?
A Quality Management System (QMS) documents processes to ensure product quality, safety, and regulatory compliance. It is mandatory for all IVD manufacturers under IVDR and MDR. - How do I apply with a Notified Body for legacy devices?
Notified Bodies assess certain device classes for IVDR compliance. Obelis helps manufacturers identify the right NB and supports the application process. - What are the new supply interruption notification requirements?
Manufacturers must notify authorities at least 6 months in advance before stopping the supply of a critical device, temporarily or permanently. - How can Obelis help manufacturers comply with the extended IVDR legacy period?
Obelis supports manufacturers by:
- Ensuring QMS compliance
- Providing Notified Body guidance
- Assisting with technical documentation
- Offering regulatory updates and compliance strategy for EU market access
References:
European Commission (2024). Regulation (EU) 2024/1860 of the European Parliament and of the Council of 13 June 2024 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices. Retrieved on 16/07/2024.
The information contained on obelis.net is presented for general information purposes only, without obligation and it has been compiled with the utmost care to ensure it remains up to date. Nevertheless, Obelis Group cannot be held liable for the accuracy and completeness of the information published. Any reliance placed on such information is therefore strictly at the User’s risk.