MDR legacy devices under Reg(EU) 2023/607

On 20 March 2023, Regulation (EU) 2023/607 amending the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) was published in the Official Journal of the European Union. This regulation allows a gradual transition to the MDR, allowing for valid previously issued Medical Device Directive (MDD)/ Active Implantable Medical Device Directive (AIMDD) certificates to be prolonged. This new timeline allows manufacturers to continue placing their devices on the market based on compliance with the Directives while they continue the transition of their devices to the MDR.

It is important to note that the longer transition timelines (up to the end of 2027/2028) apply only to devices that are transitioning to the MDR and meet other specific conditions. These conditions are aimed at ensuring that the manufacturer has taken steps to transition to the MDR.

The EU Commission published a flowchart to identify whether or not a device is covered by the extended transitional period. The flowchart can help to determine the eligibility, conditions, and deadlines for placing the device on the market or putting into service certain devices in accordance with MDR Article 120.

QMD Services has implemented a process for issuing such Confirmation Letters to those devices that qualify for extended transition periods. For clients where their current Notified Body cannot offer such a Confirmation Letter, please contact us through our contact form. Please be sure to provide full information, as the time to the deadline is limited.

Manufacturers with Directives certificates (MDD) and that qualify for benefitting from the extended transition timelines can request appropriate surveillance for the relevant legacy devices by QMD Services. The (EU) 2023/607 Regulation allows the transfer of appropriate surveillance for the relevant legacy devices from the MDD NB to QMD Services. The transfer of appropriate surveillance must be completed no later than 26 September 2024.

If you intend to transfer the appropriate surveillance of any of your legacy devices certified by another NB to QMD, please contact us as soon as possible to allow the transfer activities to be completed before the 26 September 2024 deadline defined in the (EU) 2023/607 Regulation.

The implementation of a Quality Management System (QMS) by May 2024 is one condition for benefitting from the extended transition timelines. If the QMS as per MDR requirements has not been implemented or its implementation is found to be ineffective and this leads to a major NC (non-conformity) being raised by the Notified Body, all legacy devices under that QMS cannot be placed on the market under the relevant Directive as long as the major NC is open.