The short answer. Legacy devices certified under the old directives can stay on the EU market until December 31, 2027 (class III and most class IIb implantables) or December 31, 2028 (other class IIb, class IIa, sterile and measuring class I, and devices that newly need a notified body). These dates come from Regulation (EU) 2023/607 and have not changed. The conditions behind them had to be met in 2024. The Commission’s December 2025 proposal to simplify the MDR and IVDR is still in the legislative process, so current law applies.
MDR deadlines by device class
| Devices | Last date to place on the market under a legacy certificate | Legal basis |
|---|---|---|
| Class III; class IIb implantable (except sutures, staples, dental fillings, braces, crowns, screws, wedges, plates, wires, pins, clips, connectors) | December 31, 2027 | MDR Art. 120(3a)(a) |
| Other class IIb; class IIa; class I sterile or with a measuring function | December 31, 2028 | MDR Art. 120(3a)(b) |
| Devices that did not need a notified body under the MDD but do under the MDR (for example reusable surgical instruments) | December 31, 2028 | MDR Art. 120(3b) |
| Class III custom-made implantable devices | May 26, 2026 (passed) | MDR Art. 120(3f) |
Conditions that had to be met
- The device still complies with the old directive and has no significant changes in design or intended purpose, and it poses no unacceptable risk.
- By May 26, 2024 the manufacturer had a quality management system in place and had lodged a formal application with a notified body.
- By September 26, 2024 the notified body and the manufacturer had signed a written agreement. From then on surveillance passed to that notified body.
- The sell-off date was removed: devices already lawfully placed on the market may continue to be made available.
IVDR deadlines
| IVD devices that newly need a notified body | End of transition | Application to a notified body by | Written agreement by |
|---|---|---|---|
| Class D | December 31, 2027 | May 26, 2025 | September 26, 2025 |
| Class C | December 31, 2028 | May 26, 2026 | September 26, 2026 |
| Class B and sterile class A | December 31, 2029 | May 26, 2027 | September 26, 2027 |
The same regulation added Article 10a to both the MDR and IVDR: since January 10, 2025, manufacturers must give notice at least 6 months before they interrupt or discontinue supply of certain devices.
EUDAMED is now mandatory
Commission Decision (EU) 2025/2371 was published on November 27, 2025. Since May 28, 2026, four EUDAMED modules are mandatory: actor registration, UDI and device registration, notified bodies and certificates, and market surveillance. The vigilance and clinical investigation modules are still under development and will become mandatory without a voluntary period.
Under the amended Article 123(3), devices already on the market, legacy devices included, must be registered within 12 months of the notice, and notified bodies have 18 months to enter certificates. By our count that means around late November 2026 for device registration and late May 2027 for certificates. The Commission has not published these two dates in a single document, so confirm them with your notified body.
The December 2025 reform proposal
On December 16, 2025 the Commission proposed a regulation to simplify the MDR and IVDR (COM(2025) 1023, procedure 2025/0404(COD)). It does not move the 2027 and 2028 dates. Among the proposed changes:
- No fixed 5 year validity for certificates; periodic reviews based on risk instead.
- Lower risk classes for some devices, such as reusable surgical instruments and some software.
- Remote audits allowed, surveillance audits every two years where justified, unannounced audits only for cause.
- 30 days instead of 15 to report serious incidents that are not a serious public health threat.
- Priority and rolling review for breakthrough and orphan devices; an orphan device derogation for legacy devices.
- Cybersecurity named explicitly in the general safety and performance requirements.
- Notified body fee reductions for micro and small companies.
Status in October 2026: not adopted. The European Parliament file is with the SANT committee (draft report June 30, 2026), with an indicative plenary date of December 14, 2026. The Council’s June 2026 progress report said more work is needed before a general approach and expected the Parliament to vote in early 2027. Plan with the current rules.
Notified bodies
The Commission counted 51 notified bodies designated under the MDR and 19 under the IVDR in December 2025. The NANDO database listed 52 active MDR notified bodies on October 8, 2026, including bodies notified by Türkiye and Norway.
What this means for a device in development
- A new device has no legacy route: it needs MDR conformity assessment from the start, so the technical file has to be built to MDR requirements during design.
- If you sell a legacy device and plan design changes, check with your notified body whether the change is significant; a significant change ends the transition for that device.
- Book notified body capacity early; reviews of new applications still take many months.
Sources
- Regulation (EU) 2023/607
- Regulation (EU) 2024/1860
- European Commission: EUDAMED first four modules mandatory from May 28, 2026
- European Commission: EUDAMED overview
- European Commission: proposal to simplify the MDR and IVDR, COM(2025) 1023
- European Parliament Legislative Observatory: 2025/0404(COD)
- Council of the EU: progress report ST 9801/26, June 5, 2026
- NANDO: notified bodies under Regulation (EU) 2017/745
What OVA does here, and where our responsibility ends
OVA Solutions is a medical device engineering group working under an ISO 13485:2016 certified quality system: 62 engineers, 220 devices developed, $125 per hour, offices in New York, Florida, the United Kingdom, Estonia and Ukraine. We design electronics, firmware and mechanics and take a device from concept to design for manufacturing. We are not a regulatory consultancy and not a contract manufacturer: the regulatory strategy and the submission stay with you or your regulatory consultant.
More from OVA: what medical device development costs, how to choose a development firm, answers from Lisa Voronkova, our quality system.
Updated on October 8, 2026.