The article highlights the key points related to the regulatory requirements in the sphere of incident reporting in the context of healthcare products allowed for marketing and use in Switzerland.
Table of content
Swissmedic, a Swiss regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the regulatory requirements for incident reporting by economic actors. The document provides an overview of the relevant requirements set forth under the existing legal framework, as well as additional clarifications and recommendations to be taken into consideration by the parties involved in order to ensure compliance.
At the same time, provisions of the guidance are non-binding in their legal nature, nor are they intended to introduce new rules or impose new obligations. The authority also reserves the right to make changes to the guidance and recommendations provided, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.
Terms and Definitions
First of all, the document provides definitions of the most important terms and concepts used in the context of incident reporting. In particular, it outlines terms and definitions relevant to medical devices and in vitro diagnostic medical devices (IVDs) as per Art. 1 MepV and Art. 1 Para. 1 IvDV.
Specific provisions for different products or groups within these regulations are clearly stated as well. Other key terms described in the guidance include:
- Product: Medical devices and IVDs, including their accessories.
- Incident: Any malfunction, performance deterioration, application error due to ergonomic features, or inadequate manufacturer information. Under MedV, this also includes undesirable side effects. Under IvDV, it additionally covers damages resulting from medical decisions or actions based on the product’s information or results.
- Serious Incident: An incident resulting in serious health deterioration, or a significant public health risk.
- Manufacturer: Any entity manufacturing or reprocessing a product, or having it developed, and marketing it under their own name.
- System Assembler: The entity assembling systems or treatment units.
- Authorized Representative: A Swiss-based entity commissioned by a foreign manufacturer to fulfill the manufacturer’s obligations.
- Importer: A Swiss-based entity placing foreign products on the Swiss market.
- Distributor: Any supply chain entity making products available in the Swiss market, excluding the manufacturer or importer.
- Economic Operator: Includes manufacturers, authorized representatives, importers, distributors, and system assemblers as per Art. 22 Para. 1 and 3 MDR.
Regulatory Background
According to the guidance, an incident refers to an event associated with a product. Serious incidents occurring in Switzerland or Liechtenstein must be reported to Swissmedic. Swissmedic systematically collects and evaluates these reports to protect patient and user health, preventing incident recurrences linked to product design, manufacture, or use issues.
The legal requirements for incident reporting are outlined in various regulations, including:
- Art. 59 HMG: Reporting obligations for medicinal products.
- Art. 57 and Art. 66 MepV: Reporting serious incidents for products under MepV.
- Art. 87 MDR: Reporting serious incidents and field safety corrective actions (FSCA).
- Art. 50 and Art. 59 IvDV: Reporting serious incidents for products under IvDV.
- Art. 82 IVDR: Reporting serious incidents and FSCA.
The guidance document MDCG 2023-3 issued by the European Commission clarifies vigilance terms and concepts under MDR, also applicable to Swissmedic reports, despite not covering IVDR products.
Obligations of Economic Operators
As further explained by the authority, economic operators, including manufacturers, system assemblers, and authorized representatives, must report serious incidents to Swissmedic if they occur in Switzerland or involve products in Liechtenstein under customs treaty law. The reporting process applies to all product classes, with some exceptions detailed in Chapter 6.1.
In particular, the applicable reporting requirements include:
- Manufacturers and System Assemblers: Must report all serious incidents. If based outside Switzerland or Liechtenstein, the authorized representative is responsible for reporting.
- Authorized Representatives: Must report and inform manufacturers or system assemblers about complaints and incidents.
- Importers: Must immediately forward complaints and reports about suspected incidents to the manufacturer or system assembler and the authorized representative.
- Distributors: Must forward complaints and reports of suspected incidents to the manufacturer and, if applicable, the authorized representative and importer.
- Specialists: Must report serious incidents to the supplier and Swissmedic promptly.
Reporting Serious Incidents
All serious incidents in Switzerland and Liechtenstein must be reported to Swissmedic, regardless of the product’s market placement date. Incidents outside these regions must be reported to the relevant foreign authority, as Swissmedic does not handle incidents outside Switzerland and Liechtenstein.
At the same time, it is important to mention that certain expected side effects and incorrect results documented and quantified in product information and technical documentation, and subject to trend reporting, are exempt from the reporting obligation.
Conclusion
In summary, the present guidance document issued by Swissmedic outlines the basics for incident reporting and provides detailed clarifications to be taken into consideration by all the parties involved in operations with medical devices. The document describes the relevant obligations of the parties involved and also provides an overview of the applicable regulations in general.
How Can RegDesk Help?
RegDesk is an AI-powered Regulatory Information Management System that provides medical device companies with regulatory intelligence for over 120 markets worldwide. It can help you prepare and publish global applications, manage standards, run change assessments, and obtain real-time alerts on regulatory changes through a centralized platform. Global expansion has never been this simple.
