The European Commission has taken a decisive step toward implementing the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR):
With the publication in the Official Journal of the European Union on 27 November 2025, the full functionality of the central registration systems was confirmed:
- The UDI database and the electronic system for product registration pursuant to Articles 28 and 29 of Regulation (EU) 2017/745 (MDR) and Articles 25 and 26 of Regulation (EU) 2017/746 (IVDR) are now fully operational.
- Likewise, the electronic system for the registration of economic operators pursuant to Article 30 MDR and Article 27 IVDR is now fully functional.
Starting 28 May 2026, the registration of economic operators and products in the new EUDAMED database becomes mandatory!
The requirements are demanding – and time is running out. But you don’t have to face this challenge alone. MDSS Consulting GmbH is here to support you as an experienced partner:
- Complete service for registering your products and economic operators in EUDAMED.
- Flexible packages – whether you need to register only a few products or manage a large and complex portfolio, we offer tailored solutions.
- Expert guidance for every step: data preparation, submission, follow-up, and compliance checks.
- Personal contact – always available for your questions at eudamed@mdssco.com (our dedicated team personally oversees this email address to ensure you receive fast, personalized, and reliable support at all times).
Act now and stay compliant! Make use of the remaining time to complete your registration on schedule. Contact us for a non-binding quote or an initial consultation. With MDSS Consulting GmbH, you are well prepared – competent, secure, and efficient.