Taking a step back in time, it is recalled that Switzerland has been considered a Third Country for Europe since May 26, 2021, i.e. since the lack of mutual recognition between the two countries on the Mutual Recognition Agreement (MRA), the agreement that gave Switzerland access to the single European market for Medical Devices as an equal partner.
In the direction of mitigating the negative impact of the separation of the two markets on the procurement of Medical Devices in the territory, both the Swiss Ordinance of May 26, 2021 on Medical Devices (ODmed) and the subsequent Ordinance of May 26, 2022 on In Vitro Diagnostic Medical Devices (ODIV) are aligned and based on the corresponding European Regulations: MDR (EU) 2017/745 and IVDR (EU) 2017/746.
Due to the lack of an institutional agreement, Switzerland has also defined measures to mitigate unfavourable consequences. More specifically, those concerning access to the central European database for Medical Devices EUDAMED, such as the obligation to designate a Swiss authorised representative (‘CH-REP’), the obligation to register economic operators with Swissmedic, the notification of serious incidents, and the recognition of EU certificates of conformity in Switzerland.
Switzerland and Legacy Devices
In the direction of a significant harmonisation to the European regulatory environment, the Swiss Federal Council, with amendments that came into force on November 1, 2023, has adapted the MepV ordinance to the requirements of the European Union, taking into account the extension of the transitional periods determined by the Regulation 2023/607 of March 15, 2023.
In Switzerland, as in Europe, Legacy Devices do not directly benefit from the extension and, therefore, must have been placed on the Swiss market before May 26, 2024, to continue to be available.
Please note that Legacy Devices are those products covered by an EC certificate issued under the Medical Device Directive MDD, 93/42/EEC or under the Active Implantable Medical Devices Directive AIMDD, 90/385/EEC which have not been recertified according to the Medical Device Regulation MDR (EU) 2017/745, on the market in Switzerland.
What is meant by placing it on the market?
As stated in Art. 4 of the Swiss ODmed Ordinance (Art. 4 par. 1) ‘placing on the market‘ means the “first making available of a device, other than a device under clinical trial, on the Swiss market”, e.g. through a transfer or supply between economic operators or from a Swiss economic operator to a healthcare facility/consumer. The indication covers both products of manufacturers placed in warehouses in Switzerland and devices of foreign manufacturers imported into Switzerland and placed in the importer’s warehouse.
The concept of placing on the market refers to each device and not to a type of device, as specified in the Information Sheet Obligations of Economic Operators CH,
Swissmedic’s concept of placing on the market does not deviate substantially from that expressed in the European Union’s Blue Guide (2022/C 247/01), according to which the manufacturer or an importer must carry out the first placing on the market.
In addition, placing a product on the market requires an offer or an agreement between two or more natural or legal persons attesting to the transfer of ownership.
As per MDR (EU) 2017/745, the Manufacturer, Importer and Distributor are the Economic Operators defined together with their obligations. In addition, as specified in the above-mentioned information guide, ‘to distribute Medical Devices in Switzerland, it is necessary to appoint a Representative (CH REP), i.e. a natural person or legal entity based in Switzerland who receives a written mandate from the Manufacturer, based abroad, authorising him to act on behalf of the Manufacturer about certain activities under ODmed/ODvid’. Thus, if the manufacturer is not based in Switzerland, its devices may only be placed on the market after appointing an authorised representative based in Switzerland.
How to establish and prove whether the device is placed on the market?
Interpretation is not always straightforward: one has to assess on a case-by-case basis whether a product is to be deemed to have been placed on the market and be prepared to prove it.
For example, if a Swiss manufacturer has products in its warehouse in Switzerland that have not been sold to another company, they are not to be regarded as having been placed on the market until the manufacturer makes the sale to the next economic actor.
In conclusion, it is essential to keep track of all the activities carried out in the phase of placing products on the market, such as agreements made with stakeholders, records of incoming goods inspections, delivery documents, and invoices. It is necessary to prepare all the appropriate documentation to prove that the regulatory requirements of the Medical Devices Ordinance MCO have been met.
Given the complexity of interpreting regulations, it is advisable to rely on expert support.
>> Thanks to Thema’s Strategic-Regulatory Consulting services, Thema can be a point of reference for the preparation of the necessary documents for accessing the Swiss market, for demonstrating compliance with the ODmed and ODIV ordinances, and can act as an Authorised Representative or Swiss Representative CH REP in full compliance with Swiss regulations.
Source:
Medical Device Ordinance MedDO
Ordinance on In Vitro Diagnostic Medical Devices
