2025 brings crucial regulatory deadlines for the medtech sector across the EU, UK, and Switzerland. Some of the key dates and requirements that a manufacturer must keep in mind include:
10 January 2025: Notification of supply interruptions
Under Article 10a of both EU MDR and IVDR, manufacturers must notify authorities, economic operators, and healthcare professionals six months in advance of foreseeable supply interruptions that last more than 60 days. They must also provide reasons for disruptions, and economic operators must relay the information promptly down the supply chain.
This obligation does not apply to custom-made devices.
2 May 2025: Conditions for extended transitional period for ‘’Annex I’’ devices in Switzerland
According to Article 106 MedDO, by 1 May 2025, sponsors of medical devices without an intended medical purpose (Annex I MedDo) must receive confirmation from the relevant authority that their application to conduct a clinical investigation to obtain clinical data for those devices is complete and can start the clinical investigation.
Manufacturers should be aware that they need to sign an agreement with a Notified Body for the conformity assessment of their Annex I MedDO device before 1 January 2028.
26 May 2025: UDI, legacy period, and IVDR application
- UDI requirements for manufacturers to affix UDI carrier on their labels: Required for MDR Class I devices and IVDR Class B/C devices. Direct marking of reusable devices: MDR Class IIa and IIb reusable devices must have direct UDI carrier markings engraved on the device.
- Conditions for extended legacy period for certain IVDs Quality Management System: All IVD manufacturers intending to benefit from the extended legacy period must have in place a QMS system according to Article 10(8) IVDR.
- Formal CE Application with an IVDR Notified Body: IVD manufacturers or their EARs of devices with a valid CE Certificate issued under the Directive 98/79/EC, and legacy devices that are up classified to class D under IVDR, must lodge a formal application to a notified body to transition to IVDR compliance. Please be aware that the contract should be signed within 26 September 2025!
27 May 2025: Report from the Commission on MDR Article 54
The European Commission should release a report on the operationality of MDR Article 54 on clinical evaluation consultation procedure. That is mandatory for class III implantable devices and class IIb active devices intended to administer or remove a medicinal product, potentially proposing amendments to MDR.
16 June 2025: New law on PMS in UK for medical devices and IVDs
The new post-market surveillance (PMS) regulation for medical devices will take effect in England, Scotland, and Wales on 16 June 2025, introducing significant new requirements for medical device manufacturers after they have been placed on the market.
18 August 2025: selected provisions for batteries
New due diligence obligations under the Battery Regulation start applying for manufacturers that place on the EU market a battery under their name (for ex. together with a medical device). Manufacturers should set up risk management system, due diligence policies, among others. The aim of this obligation is to tackle actual and potential social and environmental risks linked to the sourcing, processing and trading of the raw materials and secondary raw materials required for battery manufacturing.
For companies with a net turnover greater than 40 million euros in the financial year preceding the last financial year, and that are not part of a group, consisting of parent and subsidiary undertakings, which, on a consolidated basis, exceeds the limit of EUR 40 million.26 September 2025: IVD legacy devices: notified body agreements
Manufacturers of legacy IVDs covered by an IVDD Certificate and those that are upclassified to Class D under IVDR must sign an agreement with their notified body by this date to maintain their legacy status.
9 November 2025: Contact lens manufacturers
Assigning and applying Master UDI-DI to contact lenses becomes mandatory after this date.
End of 2025: Evaluation of MDR and IVDR
The European Commission will conclude its evaluation of the MDR and IVDR, supported by a public consultation that is open from 12 December 2024 to 21 March 2025. The final report is expected in Q4 2025.
These deadlines underscore the need for MedTech stakeholders to prepare for regulatory changes. Staying ahead of these developments is essential to ensure compliance and market continuity.
Follow MDlaw and you will never miss a deadline relevant for your business. If you need support with your IVD legacy device, Obelis can support you in applying to a Notified Body and setting up a QMS.
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