Revised Obligations to Act for Distributors of Medical Devices
Health / Life Sciences
Trade / Logistics
This article provides an overview of the call for action resulting from the revised regulation for distributors of medical devices.
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. To this end, the regulatory requirements for the players involved are being tightened considerably.
Having already presented the new requirements for manufacturers and importers, this article provides an overview of the need for action resulting from the revision for distributors of medical devices. A compilation of the obligations under the new law for healthcare facilities in Switzerland will round off our coverage. All articles from this series and a flyer with an overview of all contents can be found in our MME magazine .
Stricter obligations to act for distributors
Inspection obligations before placing on the market
The distributor has various inspection obligations with regard to conformity and labeling before placing medical devices on the market. For example, he must ensure that the necessary conformity marking is attached, that the declaration of conformity is available, that the importer is indicated and that the product labeling is correct. Furthermore, he must check whether the UDI number (Unique Device Identification) for product identification (where required) has been assigned and applied by the manufacturer, whereby random checks satisfy the requirements.
Disclosure and retention obligation
Furthermore, a disclosure and retention obligation for ten years (principle for all products) or 15 years (exemption rule for implants) must be observed for distributors. Disclosure and retention relate to information on sources of supply and purchasers. The documentation and proof of the entire value chain is intended to ensure the traceability of medical devices. In this respect, product monitoring requires close cooperation between manufacturers, distributors and importers.
Information and notification obligations
If it is established that medical devices are not compliant, distributors are also subject to the information and notification obligations vis-à-vis manufacturers (authorized representative, if applicable) and the competent authority Swissmedic, provided that a serious risk is to be assumed. The threat of a penalty of up to three years imprisonment or a fine applies if defective medical devices are placed on the market.
Storage and transport according to safety and performance requirements
The storage and transport of medical devices must be carried out by distributors in accordance with the manufacturer's specifications.
Quality management and documentation
Finally, distributors of medical devices are subject to a detailed technical documentation obligation of product surveillance data and the obligation to maintain an adequate quality and risk management system. The duty requires keeping a register of complaints, recalls and withdrawals, and forwarding information to manufacturers and importers. In this respect, distributors are also obliged to keep manufacturers and importers informed about monitoring measures.
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.
The most important provisions, which concern, among other things, the requirements for market introduction, market monitoring or the new requirements for clinical trials, were put into force on May 26, 2021.
Our team specializing in healthcare law will be happy to assist you with any legal issues related to the distribution of medical devices and provide practical support for your business activities in compliance with national and international regulation of medical devices.