The European Parliament and Council voted today (16 Feb 2023) to grant an extension of the transition period of the European Union Medical Device Regulation (EU MDR) to ensure public health protection, including patient safety and to avoid of shortages of medical devices, without lowering current quality and safety requirements. Once published in the Official Journal of the European Union, the extension becomes official. This is anticipated quickly. The amendments to the EU MDR and IVDR are as follows.
Extension of the transition period for legacy devices
- 31 December 2027 – Class III devices and Class IIb implantable (except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors)
- 31 December 2028 –Class IIb, Class IIa, Class Im/s and the following Class IIb implantables; sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors.
The extended transition period is subject to conditions.
- the devices must continue to comply with the MDD/AIMDD,
- do not undergo significant changes in design and intended purpose
- comply with MDR requirements related to post-market surveillance, market-surveillance, vigilance, and registration of economic operators and devices.
- Device must not present an unacceptable risk to the health or safety of patients, users third parties
- By 26 May 2024
- the manufacturer must have in place a QMS compliant with MDR
- the manufacturer/authorized representative must have lodged an application with a notified body for a conformity assessment for the legacy device or a device intended to substitute the legacy device
- By 26 September 2024 the manufacturer and notified body must have signed a written agreement.
Transition period for custom-made Class III implantable devices
The amendment also included custom-made Class III implantable devices which may be placed on the market or put into service until 26 May 2026 without a certificate issued by a notified body.
To be eligible:
- the manufacturer/authorized representative has lodged an application with a notified body by 26 May 2024 and have a signed agreement in place by 26 September 2024.
Deletion of the ‘sell-off’ deadline
The amendment removes the ‘sell-off’ period for devices and in vitro diagnostics already on the market that are safe to use; they can remain on the market.
Certificates issued by notified bodies in accordance with MDD/AIMDD shall remain valid and become re-valid (if expired under certain conditions) until the new dates for the relevant risk class of the devices.