🔍 Regulatory Context
Implementing Regulation (EU) 2021/2226 specifies the conditions under which manufacturers may provide instructions for use (IFU) for certain medical devices in electronic format, in accordance with Regulation (EU) 2017/745 on medical devices (MDR).
🆕 Key changes introduced by Regulation (EU) 2025/1234
- Expansion of the Scope of Application
- Electronic IFUs may now be provided for all medical devices and their accessories intended for professional use, including those covered by the transitional provisions of Article 120 of the MDR.
- This provision also applies to non-medical devices listed in Annex XVI of the Medical Device Regulation, provided they are intended for professional use.
- Printed instructions for use are required for non-professional users
- If a device can also be used by laypeople (patients, caregivers, etc.), manufacturers must provide a paper version of the instructions intended for these users.
- Integration into Eudamed
- Once the relevant Eudamed modules are activated, manufacturers will be required to enter the URL where the electronic IFUs are available into the IUD database.
- Regulatory Clarification
- Certain redundant requirements have been removed, as they are covered by the conformity assessment under the RDM. This simplification is intended to eliminate ambiguities and avoid regulatory duplication.
📅 Effective Date
Regulation (EU) 2025/1234 was published in the Official Journal of the European Union on June 26, 2025. It enters into force on July 16, 2025, twenty days after its publication.