As the Head of the EU Division at Arazy Group Consultants Inc., I want to share essential regulatory updates from the first half of 2025. These changes are critical for medical device and IVD manufacturers navigating the evolving landscape in the EU, UK, and Switzerland.
Final UDI Compliance Deadline – 26 May 2025
This date marks the final major deadline for UDI compliance under the MDR and IVDR. To remain on the EU market, all Class I medical devices and Class B and C IVDs must now have compliant UDI labelling and registration.
Previous Deadlines Already in Effect:
Note: IVDR Class A non-sterile devices have a later UDI deadline of 26 May 2027.
For more details, see the official UDI deadline reference.
Important for Legacy IVDs:
Manufacturers of legacy IVDs under the IVDD must submit an application and sign a written agreement with a Notified Body by 26 September 2025. This is necessary to maintain valid certificates under the extended IVDR transition (EU Regulation 2024/1860).
New MDCG Guidance (2025):
Post-Market Surveillance (PMS) Rules – Effective 16 June 2025
The new PMS rules introduce stricter vigilance timelines, trend analysis, and mandatory field safety procedures.
CE-Marked Devices Still Accepted:
Alignment with EU Transitional Periods
Switzerland has formally adopted the EU’s extended transitional periods for medical devices and IVDs. The Federal Council made this decision on 20 November 2024, and it entered into force on 1 January 2025.
Swissdamed Registration Deadline – 1 July 2026
All medical devices and IVDs must be registered in the new Swissdamed database by this date.
Swissmedic Updates:
Swissmedic has released updated maintenance and reporting guidance, including a revised MIR form that becomes mandatory in November 2025.
2025 is a pivotal year for regulatory affairs teams. Whether placing products in the EU, UK, or Switzerland, now is the time to:
At Arazy Group Consultants Inc., we ensure you are always ahead of the game, and we provide:
Talk to our experts today.