Update - Welcome to the July Issue of EU MDR & IVDR Insider

This month’s key update comes from MDCG 2025-5, which offers much-needed clarity on how performance studies are managed under the IVDR. The guidance outlines when ethics approvals are required, how to handle substantial study changes, and what expectations apply for data integrity and traceability. For IVD manufacturers preparing or updating studies, it’s an essential reference.

Several additional developments are shaping the European and global regulatory landscape:

• Switzerland has introduced a formal reimbursement framework for digital health applications, offering new access pathways under mandatory insurance.
• The MHRA’s International Recognition Procedure is now active, allowing UKCA approvals based on trusted decisions from regulators like the EU, US, Canada, and Australia.
• The revised ISO 10993-1:2025 introduces expanded requirements for biological risk assessment, including clearer definitions of contact duration and end-of-life safety.
• MDCG 2025-7 outlines the phased implementation of UDI-DI and EUDAMED for vision-related devices, with deadlines starting in 2026.

As always, our goal is to help you navigate these evolving requirements with practical guidance and clear insights.

Upcoming Live Webinar

Join us for: Risk-Based Decision Making in MedTech: From Compliance to Confidence

• August 19, 2025
• 4 PM CET / 10 AM ET*
• Speakers: Industry and Notified Body experts

*Recording and slides available to all registrants