A much-awaited extension of the MDR transition period became effective today with the publication of Regulation (EU) 2023/607 in the Official Journal of the European Union. Starting today, manufacturers of MDR legacy devices may benefit from longer deadlines to certify their products.
In a nutshell, Regulation (EU) 2023/607 introduces the following main changes:
- Extension of MDR transition period until 31 December 2027 or 31 December 2028, depending on the risk class of the device;
- Removal of the “sell-off” period in the MDR and IVDR;
- Introduction of a transition period until 26 May 2026 for class III custom-made implantable devices.
However, the extension is subject to several conditions to ensure that only safe devices, for which the manufacturer has applied for MDR conformity assessment by 26 May 2024, may benefit from the new transition period.
I. Rationale for adoption of Regulation (EU) 2023/607
The extension of the transitional provisions aims to address the risk of medical device shortages in the EU market. With 21,376 products holding certificates issued under Directives 93/42/EEC and 90/385/EEC and expiring by 26 May 2024, Notified Bodies estimated that they could only issue around 7,000 MDR certificates by that date.
Furthermore, both the MDR and the IVDR provided for the so-called sell-off, i.e. a date after which legacy devices already placed on the market could no longer be marketed, making thousands of essential devices unavailable.
Regulation (EU) 2023/607 is part of a set of instruments adopted by the EU institutions and the Medical Device Coordination Group (MDCG) to cope with the impossibility, for many companies, of complying with the new rules within the deadlines originally outlined in the MDR and IVDR. These instruments include, among others:
- Regulation (EU) 2020/561, which postponed the MDR applicability date from 26 May 2020 to 26 May 2021;
- Regulation (EU) 2022/112, which modified some transitional provisions contained in the IVDR;
- Implementing Regulation (EU) 2022/2346, which established common specifications and an ad hoc transition period for devices without an intended medical purpose listed in Annex XVI to the MDR;
- MDCG position paper 2022-18 on the application of Article 97 of the MDR;
- MDCG position paper 2022-14 on the transition to the MDR and IVDR.
II. How Regulation (EU) 2023/607 impacts the medical device industry
In a nutshell, Regulation (EU) 2023/607:
1. Allows manufacturers to place legacy devices on the market until:
- 26 May 2026, for class III custom-made implantable devices;
- 31 December 2027, for high-risk devices;
- 31 December 2028 for medium and low-risk devices.
2. Eliminates the sell-off provisions included in both the MDR and the IVDR.
However, Regulation (EU) 2023/607 outlines some conditions, requirements, and deadlines that manufacturers must meet to benefit from the extended transition period.
A. Extension of MDR transition period for legacy devices
Regulation (EU) 2023/607 automatically extends certificates of MDR legacy devices that were valid on 26 May 2021, as well as the deadline by which manufacturers may place these products on the market (previously set on 26 May 2024).
In particular, Regulation (EU) 2023/607 provides that certificates valid on 26 May 2021 will be automatically extended – and devices may be placed on the market – until:
(a) 26 May 2026, for class III custom-made implantable devices;
(b) 31 December 2027, for class III and class IIb devices (with some exceptions);
(c) 31 December 2028, for class IIa, IIb devices (not covered by point b), class I sterile devices or with measuring function, as well as devices qualified as class I under the directives but which conformity assessment procedure under the MDR requires the intervention of a Notified Body.
B. Removal of the MDR and IVDR sell-off
The proposal eliminates the so-called sell-off, that is the date beyond which legacy devices placed on the market could no longer be commercialized.
Therefore, Regulation (EU) 2023/607 allows manufacturers to commercialize MDR and IVDR legacy devices without temporal restrictions insofar as these devices were placed on the market within the new deadlines set by the extended transition period.
III. Who may benefit from the extended transition period?
Regulation (EU) 2023/607 does not apply indiscriminately to all manufacturers and MDR legacy devices.
To benefit from the extended transition period, manufacturers must:
i. By 26 May 2024, establish a quality management system (QMS) compliant with the MDR;
ii. By 26 May 2024, submit a formal application to a Notified Body for the conformity assessment;
iii. By 26 September 2024, enter into an agreement with the Notified Body for the conformity assessment.
In addition, the extension of the transitional regime only applies to MDR legacy devices that:
- Continue to comply with the relevant directive;
- Do not present significant changes in design or intended use; and
- Do not present unacceptable risks to the health and safety of patients and users.
Regulation (EU) 2023/607 provides an additional requirement for legacy devices with an expired certificate. These products may only benefit from the extended transition period insofar as:
- The manufacturer – before the certificate’s expiration – has concluded a contract with a Notified Body for conformity assessment under the MDR; or alternatively
- The manufacturer benefitted from an exemption under either Article 97 or 59 of the MDR, which provide derogations from applicable rules in particular cases
IV. Final considerations
The extension of the transition period meets the demands of the medical device industry, which has long been calling for a more flexible deadline to certify MDR legacy devices.
However, Regulation (EU) 2023/607 provides that these measures should not be applied indiscriminately but only to those companies that have already embarked on the path of MDR compliance. In this sense, manufacturers must (i) implement the QMS and (ii) submit a formal application to a Notified Body by 26 May 2024. By 26 September 2024, manufacturers must enter into an agreement with the Notified Body for the conformity assessment.
In light of the above, the extension of the transition period is undoubtedly good news for medical device manufacturers. However, the need to meet the first deadline (by 26 May 2024) requires prompt action to ensure compliance with the new rules.