Notification Procedure for Devitalised Human Tissue Products in Switzerland – Swissmedic Guidance

Regulatory Classification and Scope

Devitalised human tissue products (allografts processed to eliminate viable cells while preserving structural integrity for transplantation) are classified as medical devices in Switzerland under the Medical Devices Ordinance (MedDO). This applies to products such as bone, tendons, skin, heart valves, and other tissues rendered non-viable through validated processes (e.g., lyophilisation, irradiation, chemical treatment). Products containing viable cells fall under the Transplantation Act and are not covered here. The notification serves as a pre-market control to verify safety, quality, and traceability. Notification of devitalised human tissue - Swissmedic

Notification Obligation

Notification is mandatory before the product is placed on the Swiss market. The responsible economic operator (manufacturer, authorised representative, or importer) must submit the notification to Swissmedic. This requirement applies regardless of risk class and includes:

• Products manufactured in Switzerland.
• Imported products from EU/EEA or third countries.
• Both sterile and non-sterile devitalised tissues.

Exemptions are limited and require prior Swissmedic confirmation.

Required Notification Content

The notification dossier must include:

• Product description (tissue type, anatomical origin, processing method, sterilisation if applicable).
• Donor screening and testing data (infectious disease markers, donor eligibility criteria).
• Validation of devitalisation process (proof of cell inactivation, preservation of biomechanical properties).
• Risk analysis and biological safety assessment.
• Conformity assessment documentation (technical file summary, declarations, certificates if applicable).
• Labelling and instructions for use (in German, French, Italian).
• Manufacturer and economic operator details (including CH-REP for foreign manufacturers).

Swissmedic may request additional information or full technical documentation.

Submission and Procedure

• Submit via the Swissmedic e-Business portal (medical devices module).
• Use the dedicated notification form for devitalised human tissue.
• Swissmedic reviews the submission and may issue a confirmation or request clarifications.
• Notification does not constitute approval but allows market placement if no objections are raised.
• Changes affecting safety or performance require a new or amended notification.

Post-Notification Obligations

• Maintain vigilance and report serious incidents or field safety actions to Swissmedic.
• Ensure traceability from donor to recipient.
• Keep records available for Swissmedic inspections.
• Update notification if significant modifications occur.

Practical Guidance

Swissmedic provides specific checklists, guidance on devitalisation validation, donor screening standards, and examples of acceptable processing methods. Early consultation is recommended for novel tissues or complex processing. The authority publishes annual statistics on notified devitalised tissue products.

This notification procedure ensures rigorous control over devitalised human tissue allografts in Switzerland, protecting recipient safety while facilitating access to essential transplant materials. Detailed requirements, forms, and contact information are available on the Swissmedic devitalised human tissue notification page. Notification of devitalised human tissue - Swissmedic