Regulation (EU) 2023/607: the MDR deadlines of 2027 and 2028, and the conditions to meet

In short. A device still covered by a certificate issued under Directive 90/385/EEC or 93/42/EEC may remain on the market until 31 December 2027 (class III and implantable class IIb) or 31 December 2028 (other class IIb, class IIa, class I requiring a notified body), provided an application was lodged with a notified body before 26 May 2024 and a written agreement was signed before 26 September 2024. Regulation (EU) 2023/607 also removed the sell-off date.

What Regulation 2023/607 changed

The text, in force since 20 March 2023, rewrites Article 120 of the MDR. Three changes matter for a manufacturer:

1. Deadlines are staggered by class, where the MDR set a single date of 26 May 2024.
2. The extra time is conditional: certification under the MDR must be under way, not merely awaited.
3. The sell-off date is gone. A device placed on the market before the end of its period may continue to be made available without a time limit.

The new deadlines

The implantable class IIb devices that go to 31 December 2028 are sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors.

A class I device that did not require a notified body under the directive and does not require one under the MDR never had a transitional period: it had to comply with the MDR from 26 May 2021.

The conditions to meet

Article 120(3c) makes the period subject to five cumulative conditions:

• the device continues to comply with the applicable directive;
• there are no significant changes in its design or intended purpose;
• it does not present an unacceptable risk to health or safety;
• no later than 26 May 2024, the manufacturer has put in place a quality management system in accordance with Article 10(9);
• no later than 26 May 2024, the manufacturer or its authorised representative has lodged a formal application for conformity assessment with a notified body, and no later than 26 September 2024, the notified body and the manufacturer have signed a written agreement.

Missing one of these milestones ends the right to place the device on the market at that date, not at the end of the period.

What already applies during the period

The transitional period does not freeze everything. During it, four blocks of MDR obligations apply in place of those of the directives: post-market surveillance, market surveillance, vigilance and registration of economic operators and devices. In practice, serious incidents are reported within the timelines of Articles 87 to 89 of the MDR, and EUDAMED registration is due as for an MDR-certified device.

The notified body that issued the directive certificate remains responsible for surveillance of the device, unless otherwise agreed with the notified body that received the MDR application, which then takes over surveillance.

What about certificates that expired before 20 March 2023?

A certificate that expired before Regulation 2023/607 entered into force is considered valid only if, before its expiry, the manufacturer had signed a written agreement with a notified body for the assessment of the device or of a device intended to replace it, or had obtained a national derogation under Article 59, or a decision under Article 97.

In Switzerland

The Medical Devices Ordinance (MedDO) adopted the same deadlines through its revision of 29 September 2023. Obligations specific to Switzerland — Swiss authorised representative, Swissmedic registration, CHRN — apply in addition and are not suspended by the transitional period.