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 subject to longer transitional provisions
The new legacy provisions foresee that IVDs meeting legacy requirements can be placed on the market until the following dates:
- 31 December 2027 for Class D and devices covered by an IVDD CE Certificate
- 31 December 2028 for Class C
- 31 December 2029 for Class B and A sterile
Most importantly, this extension applies under two major conditions, namely:
- Having submitted an application with a notified body within the following deadlines:
- 26 May 2025 for Class D
- 26 May 2026 for Class C
- 26 May 2027 for Class B and Class A sterile devices
- Having a Quality Management System (QMS) in place compliant with the IVDR requirements at the latest by 26 May 2026.
In addition, if a device is covered by a Directive’s (IVDD) Certificate, it must be valid and not withdrawn on 9 July 2024. If the Certificate has expired before 9 July 2024, the legacy period applies only if an agreement with a notified body was signed before the expiry date of the Certificate or the device is allowed on the market on the basis of national derogation measures (e.g., extension granted).
How to have a QMS compliant with IVDR 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.
How to apply 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.
More changes under the amended MDR and IVDR
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?
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.