This article provides an overview of the need for action that arises for importers of medical devices as a result of the current change in the law.
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, among other things, the regulatory requirements for the involved actors are considerably tightened. This article provides an overview of the need for action that arises for importers of medical devices as a result of this change in the law.
Stricter duties to act for importers
Inspection obligations before placing on the market
Before placing medical devices on the market in Switzerland, importers are subject to various inspection obligations with regard to conformity and labeling. For example, before placing the device on the market, they must ensure that the necessary conformity marking has been affixed, that the declaration of conformity and the instructions for use are available, that the manufacturer is known or, if applicable, that the authorized representative has been designated, that the product labeling is correct and, finally, that the UDI number (Unique Device Identification) for product identification (where required) has been assigned and affixed by the manufacturer.
Obligation to disclose identification
In addition to these inspection obligations, importers must also disclose their own identity, designating their name and address on the medical device itself, its packaging, or an accompanying document.
Disclosure and retention obligation
Furthermore, importers are subject to a disclosure and retention obligation for ten years (or 15 years for implants). Disclosure and retention concern information on the sources of supply and the purchasers. The documentation and proof of the entire value chain should ensure the traceability of medical devices. Product monitoring requires close cooperation between manufacturers, distributors and importers.
Information and notification obligations
If a non-conformity of medical devices is detected, importers are subject to strict information and notification obligations vis-à-vis the manufacturers (or, if applicable, the authorized representatives) and the competent authority Swissmedic. Importers are therefore obliged, as before, to immediately forward complaints about defective medical devices to the aforementioned authorities and to collect them. A violation of these obligations can be sanctioned with a prison sentence of up to three years or a fine.
Storage and transport according to safety and performance requirements
The storage and transport of medical devices must be carried out by importers in accordance with both the manufacturer's specifications and the basic safety and performance requirements set out by law.
Obligation for documentation as well as quality and risk management
Furthermore, importers of medical devices are required to provide detailed technical documentation of product surveillance data and to maintain an adequate quality and risk management system. This obligation requires keeping a register of complaints, recalls and withdrawals, forwarding information to manufacturers and distributors, and keeping a copy of the respective declaration of conformity of medical devices.
Obligation to register or supplement registration in the information system
And finally, importers also have to comply with a registration obligation or must supplement the registration in the information system by the manufacturer with their own data.
Entry into force of the revision
For reasons of coherence, the new provisions of medical device law in Switzerland were put 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.
The most important provisions, including the new requirements for market introduction and market surveillance or the new requirements for clinical trials, were put into force on May 26, 2021.
Our specialized team in health law will be happy to assist you in all matters relating to the import and placement on the market of medical devices. We provide you with fast and practical support in clarifying open questions in connection with the regulation of medical devices.