Certain legacy medical devices and in vitro diagnostic devices may continue to be placed on the EU market during an extended transitional period, but only when the applicable conditions and deadlines have been met.
Regulation (EU) 2023/607 extended the MDR transitional periods and removed the MDR and IVDR sell-off dates. Regulation (EU) 2024/1860 subsequently introduced new IVDR transitional deadlines.
This guide reflects the rules in force on 6 August 2026. The European Commission Q&A documents provide practical guidance, but the MDR, IVDR and amending regulations remain the binding legal sources.
MDR and IVDR transition deadlines at a glance
| Device category | Latest date for placing the device on the market or putting it into service | Status on 6 August 2026 |
|---|---|---|
| MDR Class III devices and Class IIb implantable devices, except the devices specifically excluded by Article 120(3a) | 31 December 2027 | QMS, application and written agreement deadlines have passed |
| Other MDR Class IIb devices, Class IIa devices, and Class I devices placed on the market in sterile condition or with a measuring function | 31 December 2028 | QMS, application and written agreement deadlines have passed |
| Qualifying MDR Class I devices that require Notified Body involvement under the MDR | 31 December 2028 | QMS, application and written agreement deadlines have passed |
| IVDs covered by a qualifying IVDD Notified Body certificate | 31 December 2027 | Application and written agreement deadlines have passed |
| Qualifying legacy Class D IVDs previously self-declared under the IVDD | 31 December 2027 | Application and written agreement deadlines have passed |
| Qualifying legacy Class C IVDs previously self-declared under the IVDD | 31 December 2028 | Application deadline has passed; written agreement deadline is 26 September 2026 |
| Qualifying legacy Class B and sterile Class A IVDs previously self-declared under the IVDD | 31 December 2029 | Application deadline is 26 May 2027; written agreement deadline is 26 September 2027 |
These dates are not unconditional grace periods. A manufacturer must demonstrate that every applicable eligibility condition was satisfied by the relevant deadline.
MDR transitional provisions under Regulation (EU) 2023/607
Regulation (EU) 2023/607 amended Article 120 MDR. A qualifying legacy device may benefit from the extended MDR transitional period only when:
- it continues to comply with the MDD or AIMDD, as applicable;
- there has been no significant change in its design or intended purpose;
- it does not present an unacceptable risk to health, safety or public health;
- the manufacturer had an MDR-compliant quality management system in place by 26 May 2024;
- the manufacturer or authorised representative lodged a formal conformity assessment application with a Notified Body by 26 May 2024; and
- the manufacturer and Notified Body signed the required written agreement by 26 September 2024.
The transition for Class III custom-made implantable devices under Article 120(3f) ended on 26 May 2026. Manufacturers cannot treat the 2027 or 2028 dates as a replacement for a condition or deadline that was not met.
The European Commission’s Revision 2 Q&A on Regulation (EU) 2023/607, published in July 2024, explains practical issues including expired certificates, conformity assessment applications, changes of Notified Body, evidence of extended certificate validity and surveillance arrangements.
IVDR transitional provisions under Regulation (EU) 2024/1860
Regulation (EU) 2024/1860 amended Article 110 IVDR. It extended the transition for devices that require Notified Body involvement under the IVDR and have an eligible IVDD certificate or declaration of conformity.
A qualifying IVD must:
- continue to comply with the IVDD;
- have no significant change in its design or intended purpose;
- present no unacceptable risk to patients, users, other persons or public health;
- have an IVDR-compliant quality management system in place by 26 May 2025;
- be covered by a formal application submitted by the class-specific deadline; and
- be covered by a written agreement with a Notified Body by the applicable class-specific deadline.
The remaining application and agreement schedule is:
| IVD category | Formal application deadline | Written agreement deadline |
|---|---|---|
| IVDs with a qualifying IVDD certificate and qualifying Class D IVDs | 26 May 2025 | 26 September 2025 |
| Qualifying Class C IVDs | 26 May 2026 | 26 September 2026 |
| Qualifying Class B and sterile Class A IVDs | 26 May 2027 | 26 September 2027 |
At the time of this update, the formal application deadline for Class C IVDs has passed. A Class C manufacturer that submitted a qualifying application by 26 May 2026 should verify that the written agreement is concluded by 26 September 2026.
Non-sterile Class A IVDs do not receive these extended transition periods. They have generally been subject to the IVDR since 26 May 2022.
The European Commission has published a separate Q&A on the IVDR transition under Regulation (EU) 2024/1860.
How can a manufacturer demonstrate eligibility for the extension?
The extension applies by operation of law when all the relevant conditions are satisfied. It is not created by a new certificate, but manufacturers still need reliable evidence for Notified Bodies, distributors, importers, authorities and procurement organisations.
The evidence may include:
- a manufacturer’s declaration identifying the devices, certificates and applicable transition date;
- the original MDD, AIMDD or IVDD certificate or declaration of conformity;
- a Notified Body confirmation letter covering receipt of the application and conclusion of the written agreement;
- evidence that the required quality management system was in place by the applicable deadline;
- the conformity assessment application and written agreement;
- documented assessments of design or intended-purpose changes; and
- current surveillance, post-market and vigilance records.
The European Commission’s medical devices overview links to manufacturer declaration and Notified Body confirmation templates.
What counts as a significant change during the transition?
The MDR and IVDR extensions require that there is no significant change in the design or intended purpose of the legacy device.
This does not mean that every change is prohibited. The manufacturer should assess and document each proposed change through its quality management system, including the rationale, regulatory impact and conclusion.
The relevant European guidance is:
- MDCG 2020-3 Rev.1 for significant changes under Article 120 MDR; and
- MDCG 2022-6 for significant changes under Article 110 IVDR.
Where the conclusion is uncertain or the applicable surveillance arrangement requires it, the manufacturer should engage the responsible Notified Body before implementing the change.
What does removal of the sell-off date mean?
Regulation (EU) 2023/607 removed the previous MDR and IVDR sell-off deadlines.
A device lawfully placed on the market before the end of its applicable transition period may continue to be made available or put into service without a separate regulatory sell-off cut-off date. This does not override the device’s shelf life, expiry date, storage requirements, safety obligations or any market-surveillance action.
Placing a device on the market and making a device available on the market are different regulatory actions. Manufacturers and economic operators should retain evidence showing when and under which legal framework each device was placed on the market.
MDR and IVDR Transition Checklist for 2026
- Confirm the regulatory status of every device. Record its current class, Directive status, certificate or declaration, applicable transition route and final transition date.
- Verify historical eligibility evidence. Confirm that the applicable QMS, application and written agreement deadlines were met. Do not rely only on the expiry date printed on an old certificate.
- Address the Class C IVDR agreement deadline. For an eligible Class C IVD with an application lodged by 26 May 2026, verify that the written agreement is signed by 26 September 2026.
- Prepare Class B and sterile Class A portfolios. The formal application and written agreement deadlines fall on 26 May and 26 September 2027 respectively.
- Control product changes. Maintain a documented assessment of whether each design or intended-purpose change is significant.
- Maintain lifecycle obligations. The MDR or IVDR requirements concerning post-market surveillance, vigilance, market surveillance and registration apply to qualifying legacy devices as specified in the transitional provisions.
- Separate transition planning from other deadlines. EUDAMED implementation follows its own timetable. See our guide to EUDAMED mandatory timelines for MDR and IVDR.
Frequently asked questions
Does the MDR or IVDR extension apply automatically?
Yes, the extension applies by law when every applicable condition is satisfied. Manufacturers should still maintain evidence demonstrating that those conditions and deadlines were met.
Can a manufacturer rely on the final transition date after missing an application deadline?
No. The final 2027, 2028 or 2029 date is available only when the required conditions, including the formal application and written agreement deadlines, have been fulfilled.
Do legacy devices continue to follow only the old Directives?
No. Although the underlying device must continue to comply with the applicable Directive, specified MDR or IVDR requirements concerning post-market surveillance, vigilance, market surveillance and registration apply during the transition.
What is the next IVDR transition milestone?
For qualifying Class C IVDs whose formal application was lodged by 26 May 2026, the manufacturer and Notified Body must conclude the written agreement by 26 September 2026. The next application and agreement deadlines for Class B and sterile Class A IVDs fall in 2027.
How MDx CRO supports MDR and IVDR transition
MDx CRO supports medical device and IVD manufacturers with:
- portfolio classification and transition eligibility assessments;
- reviews of declarations, certificates, applications and written agreements;
- quality management system and technical documentation gap assessments;
- significant-change assessments and documentation;
- MDR and IVDR remediation programmes;
- Notified Body strategy and submission support; and
- transition roadmaps for multi-device portfolios.
For an example of portfolio-level implementation, read how MDx CRO supported an IVDR transition for a precision medicine portfolio.
Explore our regulatory affairs and technical documentation services or contact MDx CRO to discuss the evidence, documentation or deadlines affecting your portfolio.
