Transitional periods: how does the move from MDD to MDR work?

Why do some devices still rely on the MDD?

The MDR has generally applied since 26 May 2021. It replaced the MDD, Directive 93/42/EEC, and the AIMDD, Directive 90/385/EEC. However, Article 120 introduced specific provisions allowing certain devices complying with the former directives to continue being placed on the market. 1  2 

Regulation (EU) 2023/607 extended these periods subject to specific conditions. A manufacturer can continue placing an eligible device on the market while preparing for conformity assessment under the MDR. The extension applies only to the groups defined in the legislation. 3  7 

These products are known as legacy devices. For each product, check its history, declaration or certificate and compliance with every condition. The fact that a product was once sold with a CE marking does not establish its current status.

Which devices qualify for the extension?

The provisions primarily cover two groups:

• devices with a relevant certificate issued under the MDD or AIMDD whose validity follows from Article 120(2),
• devices for which the MDD did not require a notified body, a declaration of conformity was drawn up before 26 May 2021, and the MDR now requires notified body involvement. 1  3 

The second group is relevant to certain former class I devices. It does not mean that every class I product has until 2028. A device that remains an ordinary class I device and still does not require a notified body receives no general deferral of the MDR on that basis. 3 

Until when can eligible devices be placed on the market?

31 December 2027

This deadline applies to all class III devices and class IIb implantable devices, except the groups listed in Article 120(3a)(a). Those exceptions include sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors. 1 

The exception applies to the specified group of class IIb implantable devices. It must not be interpreted as automatically moving any device on that list to the 2028 deadline regardless of its class.

31 December 2028

This deadline covers the remaining class IIb devices, class IIa devices and class I devices placed on the market in sterile condition or with a measuring function, provided the relevant conditions are met. Devices covered by Article 120(3b), for which notified body involvement became mandatory only under the MDR, can also use the transition until the end of 2028. 1  3 

Classification under the MDR determines the end of the transitional period. The class shown on an old MDD certificate may therefore be insufficient to select the correct deadline. 3 

26 May 2026: a separate period has already ended

The separate provision in Article 120(3f) covered class III custom-made implantable devices. It allowed them to be placed on the market without the certificate required by the relevant MDR procedure until 26 May 2026, subject to a timely application and agreement with a notified body. This special period had already ended by the verification date of this article. 1  3 

Which conditions had to be met?

Article 120(3c) sets cumulative conditions. An eligible device must continue to comply with the MDD or AIMDD, must have no significant changes in design or intended purpose, and must not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of public health protection. 1 

There were also conditions with specific dates:

1. By 26 May 2024, the manufacturer had to put in place a QMS in accordance with Article 10(9) MDR.
2. By 26 May 2024, the manufacturer or authorized representative had to lodge a formal application with a notified body for conformity assessment of the relevant device or a device intended to replace it.
3. By 26 September 2024, the manufacturer and notified body had to sign a written agreement in accordance with the relevant requirements of Annex VII. 1  3 

In 2026, these dates are in the past. The review must establish whether the required actions were completed on time and covered the device concerned. A request for a quotation is not a formal application, and discussions about working together do not replace a signed agreement.

By May 2024, the QMS had to address how compliance with the relevant MDR requirements would be achieved. The Commission also explained that, for legacy devices, some of these requirements did not yet have to be fully implemented at device level. Distinguish the system's readiness to transition to the MDR from completion of the assessment of a particular product. 3 

What if the expiry date printed on a certificate has passed?

In certain cases, certificate validity was extended by law. The printed date alone may therefore not mean that a certificate is no longer valid. However, the extension does not apply to every expired certificate. 1  3 

Article 120(2) covers relevant certificates issued from 25 May 2017 that were valid on 26 May 2021 and were not subsequently withdrawn. Additional conditions apply to certificates that expired before 20 March 2023. These include an earlier agreement with a notified body or an appropriate decision by the competent authority. 1  3 

As practical evidence of status, collect the old certificate, its device scope, the manufacturer's declaration that the conditions are met and confirmation from the notified body. The Commission's Q&A describes these supporting documents. They do not replace the legal conditions or create eligibility that the device does not have. 3 

Which obligations apply during the transitional period?

Article 120(3d) requires the MDR provisions on post-market surveillance, market surveillance, vigilance and registration of economic operators and devices to apply in place of the corresponding directive provisions. Appropriate notified body surveillance is also required for devices covered by the relevant certificate and agreement. 1  4 

This does not automatically make every MDR requirement applicable to a legacy device. For example, the Commission states that legacy devices are not subject to MDR requirements for UDI assignment. EUDAMED registration and the identifiers used for that purpose need a separate assessment. 3  4 

The first four EUDAMED modules have been mandatory since 28 May 2026. When reviewing a portfolio, consider the specific registration rules and deadlines for devices already on the market. The phased rollout of the database does not exempt manufacturers from PMS or incident reporting obligations. 5 

What is a significant change?

During the transitional period, the impact of a change on the design or intended purpose must be assessed. MDCG 2020-3 rev.1 contains flowcharts and examples to help distinguish significant from non-significant changes. Applying them requires consideration of the particular device and the scope of the modification. 6 

An extension of the intended purpose or the introduction of a new patient population may lead to a change being assessed as significant. Document corrections and software updates do not all have the same status. A company's internal category of "major change" must not be treated as equivalent to the regulatory term in Article 120.

If a planned modification is significant, the changed device requires the appropriate MDR conformity assessment before it is placed on the market. Complete the assessment before implementing the change in production and labeling. 6 

What does this mean in practice?

Review individual devices and configurations instead of assigning a single "company in transition" status. The recommended sequence is:

Hypothetical example: two versions in one family

Must stock be withdrawn when the period ends?

Distinguish placing on the market from subsequent making available. Placing on the market is the first making available of an individual device on the EU market. Transitional provisions therefore do not apply solely at model-name level. 1 

Regulation 2023/607 removed the general deadline for further making available, known as the sell-off date. Devices lawfully placed on the market before the relevant deadline may continue to be made available or put into service. Their shelf life, storage conditions and safety requirements still apply. 3 

Keeping a product in the manufacturer's warehouse does not prove that it was already placed on the market. For stock, establish its actual stage in the supply chain and retain the relevant evidence.

How can Neximed help organize the work?

Review findings may call for corrective actions and training. CAPA in Neximed allows actions, deadlines and evidence of completion to be assigned and effectiveness to be assessed. Training supports training plans and records, as well as evaluation of training effectiveness.

The platform does not give a device legacy status or extend a certificate. A discussion of the process helps define how to manage the tasks resulting from the manufacturer's assessment.

What should be checked now?

Verified on 15 October 2026. Educational material on the EU market. A particular device's eligibility for a transitional period requires assessment of its documents and change history.