Legacy Device Transition Deadlines under MDR Article 120(3a)

1. Key takeaways

Under Article 120(3a) of the MDR, as added by Regulation (EU) 2023/607: Class III devices and Class IIb implantable devices other than sutures, staples, dental fillings, dental braces, dental crowns, screws, wedges, plates, wires, pins, clips and connectors may be placed on the market until 31 December 2027; other Class IIb devices, Class IIa devices and Class I devices placed on the market in sterile condition or having a measuring function may be placed on the market until 31 December 2028. The amended Article 120(4) no longer sets a sell-off deadline: devices already legally placed on the market may continue to be made available without a terminal date. Together, these rules define which legacy products can still enter the market under the old certificates and what happens to stock that is already in the supply chain.

2. Legal basis

3. Expert insights

Insight 1: The most common error in circulation concerns the dates.

The official dates are 31 December 2027 and 31 December 2028, not May 2027 and not May 2028. Both dates were added by Regulation (EU) 2023/607 (adopted 2023-03-15) and do not appear in the original 2017 text. Verification must be performed against the text of 2023/607 on EUR-Lex, not against press releases or industry articles. Because these deadlines drive production plans, inventory strategies and customer commitments, an error of a few months propagates directly into supply decisions, so the source of every cited date should be recorded in the internal compliance file.

Insight 2: The qualifying thresholds have all expired; manufacturers that missed them no longer enjoy the extension.

Article 120(3c) conditions the extension on five cumulative requirements: first, continued compliance with Directive 90/385/EEC or Directive 93/42/EEC; second, no significant changes in the design and the intended purpose; third, no unacceptable risk to the health and safety of patients, users or other persons, or to other aspects of public health; fourth, a quality management system in compliance with Article 10(9) established no later than 2024-05-26; and fifth, a formal application submitted to a notified body no later than 2024-05-26, together with a written agreement signed no later than 2024-09-26. All three deadlines have passed. Devices for which the conditions were not met in time do not enjoy the extension, and for them only one route remains: to stop placing the devices on the market until a valid MDR certificate exists.

Insight 3: The sell-off deadline has been deleted, a benefit that is widely overlooked.

Under Article 120(4) as amended by (EU) 2023/607, devices legally placed on the market before 2021-05-26 under the two directives, and devices legally placed on the market from 2021-05-26 onwards under paragraphs 3, 3a, 3b and 3f, may continue to be made available on the market or put into service. The provision contains no terminal date. This means that a device legally placed on the market before 2027-12-31 does not become unlawful on 2028-01-01; it can be supplied until sold out or until the end of its life. The key distinction is between placing on the market, the one-time first supply of an individual unit, and making available on the market, any subsequent supply of that unit. Inventory and contract terms should be built on this distinction.

Insight 4: Up-classified devices and Class III custom-made implantables have their own arrangements.

Under Article 120(3b), devices that did not require a notified body under Directive 93/42/EEC but do require one under the MDR, and whose declaration of conformity was drawn up before 2021-05-26, may be placed on the market until 2028-12-31. Under Article 120(3f), Class III custom-made implantable devices could be placed on the market without a notified body certificate until 2026-05-26, subject to the same conditions of application submission by 2024-05-26 and a signed written agreement by 2024-09-26. That date has passed: from 2026-05-27, such devices require a certificate under the second subparagraph of Article 52(8). Legacy portfolios should be sorted against each of these gates, not only against the two headline deadlines.

4. Practical recommendations

1. Classify every SKU under the MDR classification, not the old directive classification, to determine which sunset tier applies, and check up-classified products with particular care.
2. Audit the evidence for the three thresholds certificate by certificate: the date the quality management system was established, the date the formal application was submitted and the date the written agreement was signed; missing any one means no extension.
3. Re-sort inventory along the boundary between placing on the market and continuing to supply, and plan production against the nodes of completing first placement before 2027-12-31 and 2028-12-31.
4. Under Article 120(3d), legacy devices remain subject to the post-market surveillance, market surveillance, vigilance and registration obligations of the MDR; no exemption applies because a device carries an old certificate.
5. Under Article 120(13), as added by (EU) 2024/1860, the interruption-of-supply notification obligation in Article 10a applies to legacy devices as well.

5. Verification checklist

• □ The sunset tier (2027-12-31 / 2028-12-31) has been determined for every SKU under the MDR classification
• □ The date of establishment of the quality management system has been verified (before 2024-05-26)
• □ The date the formal application was submitted has been verified (before 2024-05-26)
• □ The date the written agreement was signed has been verified (before 2024-09-26)
• □ Article 120(3b) has been confirmed for up-classified devices (2028-12-31)
• □ MDR post-market obligations have been assigned to legacy devices under Article 120(3d)
• □ Article 10a processes have been assigned to legacy devices under Article 120(13)

Regulatory information verified as of 29 October 2026.

About GRZAN. GRZAN manages legacy transition programmes for manufacturers holding certificates issued under Directives 90/385/EEC and 93/42/EEC who must complete certification under Regulation (EU) 2017/745. We audit your portfolio against the Article 120(3a) deadlines and eligibility conditions, rebuild lapsed files into MDR-compliant technical documentation and quality management systems, and steer applications through notified bodies so your CE marking route in the European Union closes before the transition windows expire. Contact info@grzanglobal.com for a transition assessment.