The MDR has applied since May 26, 2021. It sets requirements for clinical evidence, technical documentation, notified body assessment, post-market surveillance, and the information supplied with devices. Legacy devices certified under the old directives can stay on the market during extended transition periods that run to the end of 2027 or 2028, depending on risk class. In December 2025 the Commission proposed a targeted revision of the MDR and IVDR, which has not been adopted.
Why it matters for labeling
Annex I, Chapter III sets out what must appear on the label and in the instructions for use. The MDR also introduced the Unique Device Identification (UDI) system and the EUDAMED database, so labels, packaging levels and registrations have to agree. Labeling and IFUs are part of the technical documentation, so changes can need to flow through the notified body.
Common mistakes
- Label content that doesn't match the technical documentation
- UDI data on labels that doesn't match the EUDAMED record
- Language versions not updated together with the master IFU
- Treating the proposed revision as if it were already in force