On February 6, 2025, Qualtech hosted a webinar on the latest regulatory updates affecting the European medical device industry. The session was moderated by Ms. Irene Lu, from Qualtech Consulting, who guided the discussion and facilitated audience engagement. Mr. Arkan Zwick provided in-depth analysis on key regulatory changes, including the MDR transition period, Article 10A, the EUDAMED database rollout, the European AI Act, and regulatory developments in the UK and Switzerland. The following are the key takeaways from the webinar, highlighting the most critical updates and compliance requirements for medical device manufacturers.
- MDR Transition Period Extension
Mr. Zwick highlighted the MDR transition period extension, which allows manufacturers additional time to comply. High-risk devices now have until 2027, while medium- and low-risk devices have until 2028. Since May 26, 2024, manufacturers who have already applied must ensure they continue to meet MDR safety and performance requirements and maintain an effective Quality Management System (QMS) to proceed with the certification process.
- Article 10A: Supply Interruption Notifications
Mr. Zwick emphasized that from January 2025, manufacturers must notify authorities at least six months in advance of any supply interruption that could impact patient care. This applies to all medical devices in the EU market.
- EUDAMED Database Rollout
The webinar also addressed the EUDAMED database rollout, expected to be fully functional by early 2026. Mr. Zwick explained that manufacturers must prepare for compliance by ensuring accurate data input and aligning their systems with the new regulatory framework.
- AI Act and Medical Devices
Mr. Zwick discussed the European AI Act, set to take effect in 2026. The regulation introduces risk classifications for AI-driven medical devices, requiring high-risk AI systems to undergo conformity assessments and meet transparency, data security, and patient safety requirements.
- UK and Swiss Regulatory Changes
Mr. Zwick provided updates on the UK's new post-market and pre-market regulations, with implementation expected by 2026. Meanwhile, Switzerland continues to require a local representative for non-Swiss manufacturers and is negotiating new conformity assessment agreements with the EU.
- Compliance Action Steps
Mr. Zwick advised manufacturers to take the following steps to stay compliant:
- Prepare for EUDAMED: Ensure systems align with new data requirements.
- Meet MDR requirements: Obtain notified body confirmation and ensure QMS compliance.
- Integrate AI governance: Address risk classifications and transparency obligations.
- Adapt to UK and Swiss regulations: Maintain compliance with evolving market standards.
Stay Ahead with Qualtech
The webinar reinforced the importance of proactive compliance, highlighting how Qualtech assists companies in implementing these measures through tailored regulatory guidance, strategic planning, and hands-on support in meeting MDR and AI Act requirements. in ensuring market access and patient safety. Qualtech Consulting Corporation continues to support medical device manufacturers in navigating these complex regulatory landscapes. Contact us today for expert guidance on compliance strategies and regulatory updates.
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