Swissmedic updates guidance on clinical investigations of medical devices
Swissmedic has published an updated version (v6.2, valid from 25 March 2026) of its information sheet on clinical investigations of medical devices, providing detailed guidance on approval procedures, sponsor obligations, and regulatory expectations in Switzerland.
The document reflects ongoing alignment with the Swiss Human Research Act (HRA) and the Clinical Trials Ordinance on Medical Devices (ClinO-MD), which in turn reference key provisions of the EU MDR (Regulation (EU) 2017/745).
Key regulatory clarifications
The guidance reinforces that clinical investigations are required whenever safety or performance is assessed in human subjects, regardless of device maturity, risk level, or number of participants.
Swissmedic distinguishes between two main categories:
Category A (post-market):
CE-marked devices used strictly according to their intended purpose
→ Approval required only from ethics committeesCategory C (pre-market or off-label):
Non-CE-marked devices or off-label use
→ Requires dual approval from Swissmedic and ethics committees, submitted simultaneously
This classification is critical for manufacturers planning clinical strategies in Switzerland, particularly when leveraging existing CE-marked devices.
Strong emphasis on ISO 14155 and MDR alignment
Swissmedic reiterates that ISO 14155 (Good Clinical Practice) remains the cornerstone standard for clinical investigations. Sponsors must:
Demonstrate compliance in the Clinical Investigation Plan (CIP)
Justify any deviations
Ensure data integrity and subject protection are maintained
The document also highlights alignment with MDR Annex XV requirements, particularly for documentation and clinical evidence generation.
Increased scrutiny on submissions and documentation
Swissmedic outlines frequent deficiencies observed in applications, including:
Missing GSPR checklists and standards lists
Incomplete manufacturer declarations (Annex XV MDR)
Insufficient documentation of risk management and safety measures
Validation timelines are strict:
10 days for formal validation
45–65 days for review (depending on complexity)
Incomplete submissions can lead to delays or rejection, reinforcing the need for robust technical documentation upfront.
Expanded guidance on safety reporting and timelines
The update provides detailed expectations for serious adverse event (SAE) reporting, including:
7-day reporting timeline for SAEs and device deficiencies with SAE potential
Immediate actions required for safety risks, including possible study suspension within 24 hours
Sponsors must implement continuous safety monitoring systems and ensure rapid communication between investigators and authorities.
New and updated elements in version 6.2
According to the change history, notable updates include:
New section on confidentiality-restricted submissions
Additional guidance on annual reporting
Updates to databases and submission processes (eMessage portal)
Expanded considerations for pregnancy and vulnerable populations
These updates reflect increasing regulatory expectations around data handling, transparency, and subject protection.
What this means for manufacturers
For medical device manufacturers, this update has several practical implications:
Clinical strategy planning must account for Swiss-specific categorisation and dual approval requirements
Documentation readiness is critical to avoid validation delays
Post-market vs pre-market positioning directly impacts regulatory burden
Safety systems and reporting processes must be fully operational before study initiation
Alignment with ISO 14155 and MDR Annex XV is not optional—it is expected
Switzerland continues to closely mirror EU MDR principles, but with distinct national procedures, making early regulatory planning essential for market access.
Read the full document below.
