Reprocessing of Single-Use and Reusable Medical Devices in Switzerland – Swissmedic Requirements

Regulatory Framework

Under the Medical Devices Ordinance (MedDO), reprocessing of medical devices is strictly regulated to maintain patient safety and device performance. The rules differentiate clearly between single-use and reusable devices, aligning closely with EU MDR principles while incorporating Swiss-specific requirements. Reprocessing must ensure that reprocessed devices meet the same safety and performance standards as originally placed on the market. Reprocessing - Swissmedic

Single-Use Devices (SUDs)

Reprocessing of devices labelled as single-use is generally prohibited in Switzerland. Exceptions are possible only under exceptional authorisation by Swissmedic in cases of:

• Demonstrated urgent public health need.
• No equivalent reusable or compliant alternative available.
• Validated reprocessing procedure ensuring full restoration of safety and performance.

Any such authorisation is time-limited, device-specific, and subject to enhanced surveillance and documentation. Unauthorised reprocessing of SUDs constitutes non-compliance and may lead to enforcement actions.

Reusable Devices

Reusable medical devices (e.g., surgical instruments, endoscopes) must be reprocessed according to validated procedures that include:

• Cleaning to remove organic/inorganic residues.
• Disinfection (thermal or chemical).
• Sterilisation (if required for the intended use).
• Functional testing and maintenance.
• Packaging and labelling for traceability.

Healthcare institutions or third-party reprocessors are responsible for:

• Establishing and validating reprocessing procedures per manufacturer instructions or equivalent standards.
• Documenting each reprocessing cycle (device identification, operator, parameters, release).
• Ensuring operator training and quality management.
• Maintaining records for traceability and audits.

Swissmedic expects alignment with international standards (e.g., ISO 17664, EN ISO 14937) and manufacturer IFU where applicable.

Responsibilities and Obligations

• Manufacturers – Provide detailed reprocessing instructions (IFU) in Swiss languages if the device is reusable; label single-use devices clearly.
• Healthcare institutions/reprocessors – Implement risk-based quality system for reprocessing; report incidents related to reprocessed devices.
• Importers/distributors – Ensure supplied reusable devices include valid reprocessing information.

All parties must report serious incidents involving reprocessed devices to Swissmedic under vigilance rules.

Practical Guidance

Swissmedic publishes checklists for reprocessing validation, guidance on single-use reprocessing exceptions, examples of acceptable procedures, and FAQs on common devices (e.g., endoscopes, orthopaedic instruments). Institutions are advised to conduct regular audits, maintain dedicated reprocessing units, and integrate reprocessing into quality management systems.

This regulatory approach balances patient safety with practical needs in healthcare settings, prohibiting risky reprocessing of single-use devices while enforcing rigorous standards for reusables. Detailed requirements, validation examples, and contact information are available on the Swissmedic reprocessing page. Reprocessing - Swissmedic