Regulation (EU) 2023/607, adopted on 15 March 2023 and published in the Official Journal on 20 March 2023, amended Article 120 of the MDR (EU) 2017/745 to extend the transition deadlines. The objective: to allow devices certified under Directives 93/42/EEC (MDD) and 90/385/EEC (AIMD) to remain on the European market while their MDR certification is being obtained.
The finding behind this text is factual. The number of notified bodies designated under the MDR and their assessment capacity remain insufficient to absorb the volume of files to be processed. Without an extension, thousands of medical devices would have had to be withdrawn from the market for lack of MDR certification within the initially set deadlines.
New deadlines by risk class (Article 120, §3a)
Regulation 2023/607 introduces a staggered timeline according to the risk class AND the implantable nature of the device. This is a point requiring vigilance: many summaries available online oversimplify and mislead on class IIb devices.
Deadline of 31 December 2027
This concerns class III devices and implantable class IIb devices, with the exception of sutures, staples, dental fillings, dental braces, dental crowns, screws, wedges, plates, guides, pins, clips and connectors (Article 120, §3a, point a).
In practice, this deadline targets high-risk devices for which the MDR transition is the most critical: active implants, prostheses, class III devices within the meaning of the classification rules in Annex VIII.
Deadline of 31 December 2028
This concerns class IIb devices not covered by point a) above (i.e. non-implantable IIb devices AND implantable IIb devices specifically excluded), class IIa devices, and class I devices placed on the market in a sterile condition or having a measuring function (Article 120, §3a, point b).
This distinction is frequently misunderstood. A non-implantable class IIb device, for example a radiotherapy device or a class IIb software, falls under the 2028 deadline, not 2027.
Special case: “up-classified” class I devices (Article 120, §3b)
The regulation also covers devices for which the MDD conformity assessment procedure did not require a notified body, for which a declaration of conformity was drawn up before 26 May 2021, and for which the MDR procedure now requires the involvement of a notified body. These devices benefit from the extension until 31 December 2028.
This is the typical case of class I devices reclassified as IIa under the MDR as a result of the new classification rules (rule 11 for software, rule 21 for substances, for example). A manufacturer that marketed its software as class I under the MDD and now finds it in class IIa under the MDR falls into this category.
The five cumulative conditions for continuation (Article 120, §3c)
The extension is not automatic. Five conditions must be met simultaneously for the device to continue to be placed on the market under the transitional regime.
- Continued directive compliance. The device must continue to comply with Directive 90/385/EEC or 93/42/EEC, as applicable (§3c, point a). The extension does not suspend the requirements of the directives.
- No significant change. There must be no significant change in the design or intended purpose of the device (§3c, point b). A significant change results in the modified device leaving the transitional regime.
- No unacceptable risk. The device must 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 (§3c, point c).
- Quality management system in place. By 26 May 2024 at the latest, the manufacturer had to have put in place a quality management system compliant with Article 10(9) of the MDR (§3c, point d). This deadline has passed. A manufacturer without a compliant QMS by that date does not meet the conditions for the extension.
- Formal application to a notified body. By 26 May 2024 at the latest, the manufacturer or its authorised representative had to have lodged a formal application for conformity assessment with a notified body. And by 26 September 2024 at the latest, the notified body and the manufacturer had to have signed a written agreement (§3c, point e). A stated intention without contractual formalisation was not sufficient. Both of these dates have also passed.
Removal of the sell-off deadline (Article 120, §4 amended)
A point often overlooked: Regulation 2023/607 removed the deadline for making available on the market for legacy devices already present in the distribution chain. In concrete terms, a device lawfully placed on the market under the MDD before 26 May 2021, or lawfully placed on the market under the transitional regime (§3a, §3b), may continue to be made available without any date limit.
This amendment directly concerns importers and distributors. A stock of compliant devices already in the chain no longer has to be sold off before a cut-off date.
What the extension does not cover
The extension applies to placing on the market. It does not defer the MDR operational obligations. Since 26 May 2021, any manufacturer marketing under the transitional regime is subject to the MDR requirements on post-market surveillance, vigilance, reporting of serious incidents, and registration of economic operators and devices (Article 120, §3d).
In other words, a manufacturer under the transitional regime operates under a hybrid regime: directive certification, but MDR surveillance obligations. Failing to understand this means exposing oneself to a non-conformity in the field even though the certificate is legally valid.
Regulatory sources
- Regulation (EU) 2023/607, EUR-Lex
- Consolidated Article 120 of Regulation (EU) 2017/745, EUR-Lex