The MDR transitional period refers to the timeframe during which medical devices with a certificate under Directives 90/385/EEC or 93/42/EEC may continue to be placed on the market or put into service, despite the applicability of Regulation (EU) 2017/745. The legal basis is Article 120 of the Regulation, whose deadlines and conditions were fundamentally revised by Regulation (EU) 2023/607. Since then, the period is not uniform but staggered according to risk class and subject to five cumulative conditions. It extends the validity of the certificates concerned by operation of law, without the need for a separate decision.
Staggered End Dates by Risk Class
Article 120(3a) as amended by Regulation (EU) 2023/607 distinguishes two end dates. Until December 31, 2027, all Class III products and implantable Class IIb products may be placed on the market; exceptions include suture material, staples, dental fillings, braces, dental crowns, screws, wedges, dental or bone plates, wires, pins, clamps, and connectors. Until December 31, 2028, the deadline applies to the remaining Class IIb products, including these exempted implants, to Class IIa products, and to Class I products placed on the market in sterile condition or having a measuring function.
For up-classified Class I products that only require the involvement of a Notified Body under the Regulation, such as certain software or reusable surgical instruments, the end date of December 31, 2028, also applies. Implantable custom-made Class III devices could be placed on the market without the relevant certificate until May 26, 2026, provided the application was submitted in due time and the written agreement with a Notified Body was signed. According to the Commission’s guidance, the classification rules of Annex VIII of the Regulation are decisive for assigning the end date, not necessarily the class indicated on the old certificate.
Conditions for Extension and Sell-off
The extended period applies only if the conditions of Article 120(3c) are cumulatively met: continued conformity with the respective Directive, no significant changes in design or intended purpose, no unacceptable risk, a quality management system according to Article 10(9) by May 26, 2024, at the latest, a formal application for conformity assessment according to Annex VII Section 4.3 by May 26, 2024, at the latest, and a signed written agreement with the Notified Body by September 26, 2024, at the latest. If any condition ceases to be met, the transitional effect ends.
The former sell-off period in Article 120(4) was deleted by Regulation (EU) 2023/607. Legally placed on the market products may therefore continue to be made available and put into service without a fixed cut-off date; only the shelf life and expiry date of the individual product are limiting factors. For in vitro diagnostic medical devices, Regulation (EU) 2024/1860 has staggered the extension of the deadlines in Article 110 of Regulation (EU) 2017/746, namely for Class D products until December 31, 2027, Class C until December 31, 2028, and Class B and sterile Class A products until December 31, 2029.
Distinction from Deadline Extension, Certificate Validity, and Derogation
The transitional period is not an extension of an individual certificate by the Notified Body and not an official authorization. It takes effect automatically if the legal conditions are met. This is to be distinguished from the derogation under Article 59, by which an authority may permit placing on the market without a completed conformity assessment procedure in the interest of public health, as well as the request under Article 97(1) to remedy a non-conformity.
The transitional period must also be distinguished from ongoing market surveillance: during the transition, the provisions of the Regulation on post-market surveillance, vigilance, and the registration of economic operators and products already apply. The Notified Body that signed the written agreement is also responsible for monitoring the covered products. The legal status of these products as a whole is discussed in the entry on legacy devices.
Relevance for clinical trials
The staggered end dates determine the timeline for clinical evidence. Anyone who needs to transition an implantable Class IIb product or a Class III product by the end of 2027 requires a robust data basis significantly earlier, because the Notified Body’s assessment, potential requests for additional information, and the updating of technical documentation precede this. For products with an end date of 2028, the window shifts, but not the necessity to systematically close evidence gaps.
In practical terms, this means: post-market clinical follow-up studies, registry evaluations, or supplementary tests must be scheduled so that results are available before the submission date, and product changes must be checked to see if they would terminate the transitional effect as a significant change in design or intended purpose. Full-service CROs like Mediconomics support manufacturers in planning evidence gaps, study durations, and submission deadlines against the relevant deadline and in transferring the results into the documentation in an auditable manner.
Frequently Asked Questions (FAQ)
Does the deadline extend automatically?
Yes, provided all conditions of Article 120(3c) are met. The extension of the deadline and the corresponding extension of the certificate’s validity occur by operation of law; no additional administrative act is required.
Is there still a sell-off period?
No. Regulation (EU) 2023/607 deleted the sell-off date in Article 120(4). Legally placed on the market products may continue to be made available; the limits are shelf life and expiry date.
Which class determines the end date?
The classification according to the classification rules of Annex VIII of Regulation (EU) 2017/745. This may differ from the class indicated on the old certificate, which is why the assignment should be checked and justified on a product-specific basis.
Regulatory References
- Regulation (EU) 2017/745, Article 120 – Transitional provisions, in particular paragraphs 2, 3, 3a, 3c, and 4.
- Regulation (EU) 2023/607 – Recasting of deadlines and conditions, and deletion of the sell-off period.
- Regulation (EU) 2024/1860 – Staggered extension of IVDR transitional periods according to Article 110 of Regulation (EU) 2017/746.
- Regulation (EU) 2017/745, Annex VII Section 4.3 – Formal application and written agreement with the Notified Body.
- European Commission, Questions and Answers on the extension of the MDR transitional period – Interpretation of the conditions of Article 120(3c).
