Switzerland: Tasks and Responsibilities of Economic Operators in Medical Device Regulation
With the revision of the Medical Devices Ordinance (MedDO) as of 26 May 2021, Swiss law has been aligned with the EU MDR and IVDR regulations. A major change pertains to the tasks and responsibilities of the various economic operators involved in the distribution of medical devices. The new issues and challenges raised by the revision are explained in detail below.
Although the revision of the law governing medical devices provides clarity, particularly with regard to harmonization with European law, the new roles and obligations of individual economic operators must be carefully examined to avoid surprises in the area of responsibilities and liability.
The economic operators and their roles
In its conception, the MedDO provides for four economic operators: the manufacturer, the authorized representative, the importer and the distributor, which are named in Chapter 6, Section 1 of the MedDO. The description of duties is consistent with the MDR. The individual operators and their roles are explained below.
Of particular note is the Swiss authorized representative, so-called “CH-REP”, who is responsible for formal and safety related matters for manufacturers based outside Switzerland and represents the manufacturer in Switzerland. The use of the symbol “CH-REP” including the name and address of the authorized representative on the product or packaging (e.g., label) is necessary so that this representative is clearly visible to the end user. The authorized representative is not necessarily part of the supply chain of the medical devices. Nevertheless, their appointment as a representative as well as their obligations towards the manufacturer must be stated in a written mandate agreement.
Unlike the authorized representative, the importer is not appointed by the manufacturer. Its regulatory role arises from the fact that it places the medical devices on the Swiss market, thereby being responsible for the compliance of the products with the MedDO. It follows that, on the one hand, several importers can coexist and, on the other hand, that the authorized representative can also assume the role of the importer. The importers can distribute the medical devices directly to the end users.
In contrast, the distributor is the one who distributes a medical device in Switzerland, i.e., transfers ownership of it. In essence, the distributor must “exercise due care in complying with the applicable requirements”.
Accordingly, pharmacies, supermarkets and web stores that sell medical devices directly to end users are considered distributors if they procure the medical devices from Switzerland and importers if they procure the products from abroad.
The special role of healthcare facilities and professionals
Healthcare facilities and healthcare professionals dispensing products obtained from abroad directly to patients as part of a treatment constitutes a special situation. In this case, there is no placing on the market or distribution within the meaning of the MedDO; that is, the products are not made available on the Swiss market in the first place. Accordingly, there is no importer and no distributor in the regulatory sense. In this situation, the appointment of an authorized representative is not mandatory.
It should be noted that in the case of direct import, the healthcare facility and the healthcare professional must comply with regulatory obligations, even if they are not one of the named economic operators within the meaning of the MedDO. They also bear certain liability risks, as will be shown below.
Specific risks associated with direct import of medical devices from abroad
In the case of direct import of devices from abroad, the procuring healthcare facility or healthcare professional is responsible for the conformity of the medical devices in accordance with Art. 70 para.1 MedDO. The procuring healthcare facility or professional must verify and ensure that a conformity assessment procedure has been carried out.
According to Art. 47d of the Therapeutic Products Act (TPA), the Swiss authorized representative and the manufacturer are jointly and severally liable to a person injured by a defective medical device. In the case of a direct import, there may be no authorized representative, which is why the healthcare facility or professional bears a liability risk. If there is no authorized representative, it is up to the healthcare facility or professional to ensure the flow of information, implement corrective measures and clarify liability issues.
With regard to the Product Liability Act (PLA), only the manufacturer, the so-called quasi-manufacturer and the importer are liable for damages caused by defective products. In any case, the importer within the meaning of the MedDO is covered by liability for damage caused by defective products, since the importer imports the products for the purpose of distribution to end users.
Healthcare facilities that (directly) import medical devices for treatment are also likely to be considered importers within the meaning of Art. 2 para. 1 lit. c PLA, since they import the medical devices into Switzerland for commercial purposes. If previously unknown product hazards and product risks are identified, there is also an obligation to avert health risks by warning end users accordingly.
Careful clarification of the various roles
The roles of the economic operators shown are associated with various responsibilities and liability risks. This is particularly true for healthcare facilities and professionals who directly import products for treatment. While these may not be considered importers or distributors for regulatory purposes, this does not absolve them from potential liability.
Especially if no Swiss authorized representative has been appointed, the healthcare facility must provide Swissmedic with the necessary information and implement corrective measures instead of the authorized representative. In addition, the healthcare facility is responsible for the conformity of the product.
With this in mind, reviewing the regulatory roles and obligations of the individual players in advance is important and expedient. By means of a coherent contractual design, the responsibilities of the parties involved should be clearly defined and unequivocally specified. Contractual exclusions and indemnification clauses also allow the operators involved to identify and limit liability risks.
01 Four economic operators with different responsibilities in the law governing medical devices
02 In the case of direct importation by healthcare facilities and professionals, there is no importer and no authorized representative, which increases the liability risk of the direct importer
03 Depending on the constellation, the liability risks are allocated differently
ABOUT THE AUTHOR: Marcel Boller and Frank Scherrer
Marcel Boller mainly advises on pharmaceutical and health issues, data protection law, compliance issues, and public procurement law.
Frank Scherrer works primarily in the pharmaceutical and health sector. He mainly advises and represents pharmaceutical companies with regard to drug approvals, permits, reimbursements, advertising and sales, the drafting of all types of contracts, data protection and product liability. Further areas of specialization include antitrust and competition law, labor law, and data law. He also advises clients on questions relating to medical devices and human research. He represents his clients in contract negotiations, as well as in official and judicial proceedings. He heads the Life Sciences Team at Wengler Vieli.
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Disclaimer: Every effort has been made to ensure the accuracy of this publication at the time it was written. It is not intended to provide legal advice or suggest a guaranteed outcome as individual situations will differ and the law may have changed since publication. Readers considering legal action should consult with an experienced lawyer to understand current laws and.how they may affect a case. For specific technical or legal advice on the information provided and related topics, please contact the author.