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January 13, 2026
Approximately 5 minutes
Swissmedic Round Table on Medical Devices (RTMT) – Industry Dialogue Platform
Swissmedic Round Table on Medical Devices (RTMT) – Industry Dialogue Platform
Purpose and Establishment
The Round Table Medical Technology (RTMT) was established by Swissmedic to foster constructive dialogue with the medical device industry following the revision of Swiss medical device legislation (MedDO) and the alignment with EU Regulations (MDR 2017/745 and IVDR 2017/746). It serves as a permanent platform for exchanging views on regulatory implementation, practical challenges, and emerging issues in the Swiss medical device sector. The RTMT promotes mutual understanding, facilitates timely feedback, and supports smooth adaptation to evolving requirements. Roundtable Medizintechnik (RTMT) - Swissmedic
Composition and Participants
- Swissmedic: Chairs the meetings and provides regulatory updates and clarifications.
- Industry Associations: Swiss Medtech, scienceindustries, and other relevant organisations represent manufacturers, importers, and distributors.
- Notified Bodies: Swiss and EU-designated bodies participate to discuss conformity assessment experiences.
- Other Stakeholders: Occasional participation by healthcare providers, patient organisations, or federal offices depending on topics.
Meetings typically occur 2–3 times per year, with additional ad-hoc sessions for urgent matters.
Key Topics Discussed
The RTMT addresses a broad range of issues, including:
- Implementation of MedDO requirements and Swiss-specific adaptations.
- Alignment with EU MDR/IVDR, including status of EU certificates' recognition in Switzerland.
- Transitional provisions, legacy devices, and phase-out timelines.
- Conformity assessment procedures, clinical evaluation, post-market surveillance, and vigilance reporting.
- Swiss-specific labelling, language requirements, and vigilance obligations.
- Challenges related to supply chain, shortages, and international harmonisation.
Outcomes and Benefits
- Regulatory Clarity: Swissmedic provides interpretations and guidance on ambiguous provisions.
- Industry Feedback: Participants raise practical difficulties, leading to adjusted implementation approaches or new FAQs/guidance documents.
- Transparency: Minutes and key outcomes are published on the Swissmedic website (in German, with summaries in French/Italian/English where relevant).
- Collaboration: The forum strengthens cooperation between regulator and industry, contributing to patient safety and market access.
The RTMT complements formal consultation processes and working groups, offering a flexible, ongoing dialogue mechanism.
This stakeholder platform exemplifies Swissmedic's commitment to proportionate, transparent, and collaborative regulation of medical devices in Switzerland. Detailed meeting agendas, minutes, participant lists, and related documents are available on the dedicated RTMT page. Roundtable Medizintechnik (RTMT) - Swissmedic
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