European Commission Publishes Updated Consolidated Version of the EU MDR 2017/745

The European Commission has released an updated consolidated version of the Medical Devices Regulation (EU) 2017/745 (MDR), incorporating all amendments and corrigenda published to date. Although this consolidated text does not introduce new legal obligations, it provides manufacturers with an important, streamlined view of the MDR as it currently applies across the EU.

For manufacturers, this consolidated version is an essential reference tool for ensuring regulatory accuracy, maintaining up-to-date conformity documentation, and supporting internal quality and compliance processes.

Impact on Manufacturers

1. Clearer visibility of all amendments and transitional provisions

The updated consolidated version integrates the most recent MDR amendments, including transitional rules, IVDR interactions and changes relating to legacy devices. Manufacturers can rely on this document to ensure that their procedures and technical documentation reflect the current legal framework.

2. Improved alignment of internal documentation

Having a single, updated reference supports QA/RA teams in maintaining consistent terminology, definitions, classification rules, and obligations across technical files, quality manuals and regulatory procedures.

3. Reduced risk of referencing outdated legal text

Many manufacturers unknowingly use outdated versions of the MDR when preparing submissions or updating internal SOPs. The consolidated version helps avoid misinterpretation and ensures full alignment with current regulatory expectations.

4. Essential for training and audit preparation

Regulatory teams, R&D, production, PMS and PRRC personnel can use the consolidated version as the core reference for internal training and audit readiness — particularly when facing Notified Bodies or competent authorities.

5. Supports global submissions referencing EU legislation

Manufacturers exporting outside the EU often need to reference MDR clauses when applying for market authorisations abroad. An updated consolidated version ensures accurate citation and regulatory consistency.

The consolidated MDR text is not legally binding on its own, but it is the most practical and reliable format for daily use. The full document is available for download below.