Legal | Tax | Compliance
Legal | Tax | Compliance
Switzerland has revised its medical device legislation in close alignment with EU regulations. The revision aims to improve the quality and safety of medical devices and thus patient safety. For this purpose, the regulatory requirements for the involved actors are considerably tightened.
Switzerland has revised its medical device legislation in close alignment with EU regulations. The revision aims to improve the quality and safety of medical devices and thus patient safety. For this purpose, the regulatory requirements for the involved actors are considerably tightened. This article provides an overview of the obligations to act that must be observed by manufacturers of medical devices.
I. General changes
The revision of the medical device law is partly very extensive and brings drastic changes regarding various obligations of medical device manufacturers.
The revision confronts manufacturers with increased conformity requirements due to the higher classification of certain medical devices. In addition, they are now subject to a comprehensive product identification obligation in that, on the one hand, they must create a trilingual implantation certificate for implants and, on the other hand, they are obligated to ensure the complete traceability of medical devices by recording them using a UDI number (Unique Device Identification) for product identification. This means that manufacturers are obliged to register all medical devices in the new information system EUDAMED (European Database for Medical Devices).
Furthermore, manufacturers are subject to a disclosure and retention obligation for ten or 15 (implants) years. There is also a detailed technical documentation obligation for product monitoring data and the maintenance of an appropriate quality and risk management system. It follows from this stricter product monitoring and reporting obligation that manufacturers must regularly prepare a safety report on their products.
The organizational measures also include the fact that manufacturers must now appoint a "responsible person" and an authorized representative based in Switzerland or the EU. Finally, all manufacturers of medical devices have been subject to mandatory insurance coverage since the revision came into force.
II. Reporting obligations for manufacturers
Manufacturers can only improve their products if they have knowledge of the weaknesses and risks of their products on the market. The aim of the more stringent reporting system is to prevent recurrences of incidents based on problems with the design, manufacture or use of medical devices.
Manufacturers are obliged to report permanent and now also temporary serious incidents in Switzerland, including undesirable and unexpected side effects, to Swissmedic. Now, after the notification, an immediate investigation of the incident and a risk assessment must be carried out by the manufacturer. He may not carry out any destructive investigation on the product before he has informed the competent authority.
Manufacturers must also immediately notify Swissmedic of any new safety measures (FSCA) required for products on the market and are also responsible for ensuring that this notification of necessary safety measures reaches the user.
With the Periodic Summary Report, the audit establishes a coordinated process for reporting similar incidents that occur frequently, are well documented, and whose cause is known.
Finally, manufacturers are now also required to discontinue a notification in the event of a statistically significant increase in the frequency or severity of non-serious events and expected adverse events in relation to the benefit-risk analysis. The manufacturer must establish the trend definition in the Postmarket Surveillance Plan. This is considered the methodology to detect statistically significant increases in frequency or severity of events.
III. Enactment
For reasons of coherence, the new provisions of medical device law in Switzerland were brought into force gradually. The exemptions for the placing on the market and putting into service of medical devices that have not undergone a conformity assessment procedure already came into force on August 1, 2020.
However, the most important provisions, which concern, among other things, the requirements for market launch, market surveillance or the new requirements for clinical trials, were put into force on May 26, 2021.
Our experienced team will be happy to assist you in all matters relating to medical device law and will actively support you in clarifying open questions in connection with the regulation of medical devices.
