Legacy devices are medical devices that hold valid CE certificates issued under the old EU directives (MDD 93/42/EEC or AIMDD 90/385/EEC) and remain on the EU market under the transitional provisions of Article 120(3) of the Medical Device Regulation (MDR 2017/745), provided they continue to meet defined conditions.
What is a legacy device?
The MDR and IVDR texts never actually define “legacy device.” The definition comes from guidance document MDCG 2021-25 (first published October 2021, revised October 2024). Under that guidance, a legacy device is one placed on the market after the MDR date of application (26 May 2021) under the Article 120 transitional provisions, on the strength of a valid MDD or AIMDD certificate. It also covers a Class I device whose declaration of conformity predates that date but which now needs Notified Body involvement under the MDR.
MDCG 2021-25 separates three populations. Legacy devices sit under the old directives but are still placed on the market during the transition. “Old devices” were placed on the market before 26 May 2021 and are no longer supplied. “MDR devices” carry certification under the new regulation.
Why legacy devices matter in medical device development
For manufacturers, legacy status keeps existing products on sale while MDR certification is in progress. Notified Body capacity has been the bottleneck for years, and reviews of 13 to 18 months are common, so a device that lost its transitional cover would face removal from the market, a direct revenue, supply-continuity, and sometimes patient-access risk.
Legacy status is conditional, not automatic. A manufacturer that misreads the conditions, or wrongly judges a change to be minor, can forfeit the device’s right to stay on sale. Regulators treat post-market obligations as fully enforceable, so audit exposure runs through the transition.
How legacy device status works
A device keeps legacy status only while these Article 120(3) conditions, as amended by Regulation (EU) 2023/607, all hold:
- The device continues to comply with the MDD or AIMDD under which it was certified.
- There is no significant change to its design or intended purpose.
- It does not present an unacceptable risk to health or safety.
- The manufacturer had a QMS meeting on MDR Article 10(9) in place by 26 May 2024.
- An application for MDR conformity assessment was lodged with a Notified Body by 26 May 2024.
- A written agreement with that Notified Body was signed by 26 September 2024.
Regulation (EU) 2023/607, in force since 20 March 2023, sets the staggered end dates that apply now. Class III and implantable Class IIb devices may stay on the market until 31 December 2027, with named exceptions such as sutures, staples, and dental items. Other Class IIb, IIa, Is and Im devices, plus Class I devices up-classified under the MDR, run until 31 December 2028. Class III custom-made implantable devices had a separate 26 May 2026 limit. The regulation also removed the earlier “sell-off” deadline, so compliant stock can stay available.
Chapter VII of the MDR applies in full to legacy devices, so post-market surveillance, vigilance, market surveillance, and registration all govern these products despite their directive-era certificates. MDCG 2021-25 confirmed one relief: no Person Responsible for Regulatory Compliance (Article 15) is required for a legacy device, though national rules can still apply.
Common challenges and best practices
The hardest judgment is usually the “significant change” test. A material substitution in a sterile barrier, a change of sterilization method, or a modification affecting performance is often significant and can trigger a full MDR conformity assessment. Teams that document a change-evaluation rationale against MDCG 2020-3 fare better in an audit than those relying on informal judgment.
A second common gap is post-market evidence. Because Chapter VII applies, PSUR and PMS files must stay current rather than wait for MDR certification, and building them early feeds the eventual clinical evaluation.
Watch the wider picture too. Regulation (EU) 2024/1860 tied EUDAMED use to module readiness. And on 16 December 2025, the Commission proposed a targeted simplification of the MDR and IVDR (COM(2025)1023), still under examination and not yet law, so current legacy-device rules are unchanged.
How SJML helps with legacy devices
SJML’s Compliance-as-a-Service team supports manufacturers managing legacy devices through the MDR transition. Capabilities span regulatory strategy and device classification, technical file and DHF remediation, ISO 13485 and ISO 14971 quality and risk file alignment, clinical evaluation, and post-market surveillance and vigilance planning. The team can assess whether a design change risks legacy status, prepare Notified Body documentation, and register devices in EUDAMED, supporting clients from startups to global OEMs across India, the U.S., and Europe.
Frequently asked questions
A legacy device is a medical device with a valid CE certificate issued under the MDD (93/42/EEC) or AIMDD (90/385/EEC) that stays on the EU market after 26 May 2021 under the MDR’s Article 120 transitional provisions. The term is defined in the guidance document MDCG 2021-25, not in the MDR text itself.
Both were certified under the old directives, but a legacy device is still being placed on the market during the MDR transition, while an “old device” was placed on the market before 26 May 2021 and is no longer supplied. MDCG 2021-25 sets out this distinction, which decides which obligations apply to each.
Under Regulation (EU) 2023/607, Class III and implantable Class IIb devices may stay on the market until 31 December 2027, and other Class IIb, IIa, Is and Im devices until 31 December 2028, provided the conditions are met. Class III custom-made implantable devices had a separate 26 May 2026 deadline.
A significant change is a modification to design or intended purpose that can end legacy status and force a full MDR conformity assessment. Examples flagged in MDCG guidance include changing a sterilization method, substituting a material in the sterile barrier, or altering a device’s performance or intended use. MDCG 2020-3 gives the assessment framework.
No. MDCG 2021-25 clarifies that a Person Responsible for Regulatory Compliance under MDR Article 15 is not required for legacy devices. National rules can still impose related obligations, such as a safety officer in some Member States, so manufacturers should check local requirements alongside the EU position.
Related terms
- EU MDR (Medical Device Regulation)
- Notified Body
- CE Marking
- Post-Market Surveillance (PMS)
- Significant Change
