MDR Transition Extension Period: Understanding the New Regulation 2023/607 for Device and IVD Manufacturers

On January 6, the EU Commission finally took steps towards addressing the potential crisis of device supply shortage as a result of the significant number of legacy devices (refer to MDCG 2021-25 on the definition of ‘legacy devices’) with MDD certificates set to expire without valid MDR certificates due to limitations on the number and resources of Notified Bodies available. While MDCG 2022-18 (published in December 2022) was intended to also assist with this problem, as a position paper on the application of Article 97 for conformity assessment extensions requests, this was meant to be a temporary measure. The steps taken by the EU Commission comprised the publication of a proposal on amendments of the MDR and IVDR.  

Impacts of Regulation 2023/607 on device manufacturers 

This proposal has now gone through the EU legislative process and came into force on March 20, 2023 as Regulation 2023/607, the impacts of which we discuss below. 

MDR Transition Extensions 

Conditions for the extension of AIMDD/MDD certificate validity

AIMDD/MDD certificates valid on the MDR’s date of application (26 May 2021) that have not been withdrawn by a Notified Body have had their validity extended, without the need for Notified Bodies to change the date on individual certificates. For those manufacturers whose certificates expired, this extension is only applicable under certain conditions: 

• • • At the moment of certificate expiration, the manufacturer has signed a contract with a Notified Body for MDR conformity assessment; OR 
    • A national competent authority granted a derogation from the appliable conformity assessment procedure under Article 59; OR 
    • A national competent authority required the manufacturer to carry out conformity assessment within a specific time period under Article 97 

The first of these conditions rewards those manufacturers that have at least been sufficiently organized to pursue MDR certification and engaged a Notified Body. For those manufacturers whose certificates have not yet expired and are yet to contract a Notified Body for MDR certification they are strongly recommended to do so, to take advantage of this extension. Under these circumstances, certificates will remain valid for the duration of the extended transition period.  

MDR extension of transition period and conditions for legacy devices 

The MDR transition period is now extended from 26 May 2024 until: 

• • • 31 December 2027 for higher risk devices (Class III and Class IIb implantable devices except certain devices for which the MDR provides exemptions, given that these devices are considered to be based on well-established technologies) 
    • 31 December 2028 for medium and lower risk devices (other Class IIb devices and Class IIa, Im, Is and Ir devices) 

MDR transition period extension only applies to legacy devices and is subject to the following cumulative conditions: 

• • • Devices must continue to comply with the AIMDD/MDD, as applicable (this would include the Technical File having to continue to demonstrate conformity with the applicable directive) 
    • Devices do not undergo significant changes in the design and intended purpose (refer to MDCG 2020-3 on relevant “significant change” guidance) 
    • Devices do not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health (as set out in Articles 94 and 95) 
    • No later than 26 May 2024, the manufacturer has established a MDR-compliant Quality Management System (QMS) (i.e. in accordance with Article 10(9)) 
    • No later than 26 May 2024, the manufacturer, or its authorized representative, has lodged a formal application for Notified Body MDR conformity assessment and that no later than 26 September 2024 the Notified Body and manufacturer have signed a written agreement in accordance with MDR requirements  

Technical documentation and QMS requirements during MDR transition period extension

As all device manufacturers must already comply with the vigilance and PMS requirements of the MDR, a particular area where manufacturers taking advantage of these extended transition period will need to take caution is in technical documentation (especially for clinical evaluation / PMCF) where documentation will need to be established demonstrating conformity with AIMDD/MDD and MDR requirements, depending upon when the Notified Body is ready to begin technical file assessment.  

This would also need to be reflected in the relevant QMS documentation to be in place by 26 May 2024. Class III implantable custom-made devices will also have a transition period of 26 May 2026 to obtain Notified Body QMS certification (as they required to comply with all applicable MDR requirements since 26 May 2021) where the manufacturer has lodged an application before 26 May 2024 resulting in the signing of a Notified Body contract before 26 September 2024. 

Deletion of the “sell-off” dates and implications for manufacturers’ inventory under the MDR/IVDR 

With the deletion of these provisions, the “sell-off” dates of 27 May 2025 (MDR) and 25 May 2025 to 26 May 2028 (IVDR) are no longer applicable. In other words, devices placed on the market prior to the end of the extended periods laid down in the MDR/IVDR can be made further available on the market without any legal time restriction. For manufacturers of medical devices with significant warehousing capability in the EU, this means that inventory already in such warehouses prior to the extended transition deadline can continue to be made available on the market with the only limitation being the lifetime of the devices in question. In the case of IVDs, the benefit of this change is most likely to be realized by manufacturers of non-reagent-based IVDs (e.g. instruments) as the shorter shelf-life of reagent-based IVDs would be a limiting factor. 

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