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Technical Documentation Review

Manufacturers seeking to place medical devices on the Swiss market must comply with the Medical Devices Ordinance (MedDO, SR 812.213) and the In-vitro Diagnostic Medical Devices Ordinance (IvDO, SR 812.219), which require comprehensive technical documentation demonstrating safety and performance compliance. This documentation includes regulatory and clinical records such as compliant labels, the Declaration of Conformity, Post-Market Surveillance (PMS) plans and reports, Summary of Safety and Clinical Performance (SSCP), and risk management and clinical evaluation reports. It must be prepared before signing the Declaration of Conformity, kept readily available for inspection, submitted to the competent authority upon request, and retained for 10 years, or 15 years for implantable devices, after the last product has been placed on the market.

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Ensure Medical Device Compliance with Technical Documentation Review

Legal background

Failure to maintain compliant technical documentation can lead to enforcement actions by Competent Authorities, putting your market access and brand reputation at risk. Beyond legal obligations, having complete and accurate documentation is a strategic advantage that supports business growth and market trust.

It is essential for:

- - Gaining and maintaining CE or MD conformity mark
  - Ensuring market access in Switzerland, the EU, and other global markets
  - Demonstrating regulatory compliance during inspections and audits
  - Avoiding penalties, product recalls, or sales bans
  - Building confidence with distributors, healthcare professionals, and regulators

Our services

How to Prepare MedDO and IVdO-Compliant Technical Documentation

As your Swiss Authorised Representative (CH-REP), Obelis provides in-depth technical documentation review services, aligned with EU MDR/IVDR and the Swiss MedDO/IVdO. Our expert team verifies the completeness, consistency, and accuracy of each element, from clinical data and PMS plans to risk analysis and declarations. We ensure your files are always inspection-ready by keeping them available for authorities such as Swissmedic, while also providing professional guidance to fill any gaps. As your Swiss Authorised Representative, we will also review your labelling to verify conformity markings, UDI carriers, and importer, manufacturer, and CH REP details are correctly included.