Import and Distribution of Medical Devices in Switzerland – Amended Rules
The import and distribution of medical devices in Switzerland is governed by the Swiss Therapeutic Products Act and the Swiss Medical Devices Ordinance (MedDO). As of 26 May 2021, MedDO has been revised, foreseeing stricter and additional obligations for the operators active on the Swiss market.
MedDo’s revision has become necessary in order to ensure the harmonization with the Medical Devices Regulation of the European Union (MDR). Alongside, the failed update of the Agreement between the EU and Switzerland on mutual recognition of conformity assessments (MRA), due to the broke off of the Bilatelars 1 negotiations, have put an end to the facilitated reciprocal market access between Switzerland and the EU. In a communication notice dated 26 May 2021, the European Commission has taken the position that it will with immediate effect discontinue the application of the MRA and cease automatic mutual recognition of Swiss origin medical devices, including acceptance of associated Swiss conformity declarations and certificates of conformity issued by authorized Swiss notified bodies. Considering the MRA to be still in force and applicable, the Swiss Federal Council has tried to mitigate third-country requirements for EU and EEA manufacturers distributing medical devices in Switzerland, in particular by granting, in the revised MedDo, transitional provisions for medical devices that were put on the market in compliance with the previous EU Medical Devices Directive (MDD) provisions.
Still, some issues as to the obligations of authorized representatives, importers and distributors of medical devices in Switzerland are still controversial and do continue to impact the distribution of medical devices in Switzerland.
Appointment of Swiss authorized representative (CH-Rep) and labelling requirements for MDD medical devices – Where the manufacturer of a medical device is not domiciled in Switzerland – thus also a manufacturer domiciled in the EU or EEA –, the device may only be placed on the market if the manufacturer designates an authorised representative domiciled in Switzerland by means of a written mandate. The CH-Rep is responsible for formal and safety-related matters in connection with the placing of the product on the market. Such a CH-Rep must be appointed until 31 December 2021 (for class III devices, class IIb implantable devices and active implantable devices), or 31 March 2022 (for non-implantable class IIb devices and class IIa devices) or by 31 July 2022 for class I devices (art. 104a MedDO). No extension of these deadlines are possible. Moreover, Swiss regulatory authority Swissmedic requires that within these deadlines the appointed CH-Rep must also be indicated on the product labels. Swissmedic’s labeling requirements are controversial as they likely do not correctly reflect the transitional periods for placing on the Swiss market MDD-compliant medical devices that were lawfully (pursuant to MRA and former MedDO) released on the EU/EEA market until 26 May 2021 and do in principle allow a placement and distribution on the Swiss market “as is” until 26 May 2024, and until 26 May 2025 respectively.
Following intensive negotiations with Swiss MedTech last autumn, Swissmedic has eventually agreed to accept an indication of the CH-Rep on the delivery note/packing slip (for MDD products of all classes) and to grant an additional transitional period until 31 July 2023 for the labelling of MDR class I products (Swissmedic Information Sheet – Obligations Economic Operators CH, https://www.swissmedic.ch/swissmedic/en/home/medical-devices/market-access/pflichten-bevollmaechtigte.html). Still, it is unclear whether this compromise solution is acceptable for all European manufacturers, in particular if they could not appoint within the deadlines CH-Rep willing to take over all the regulatory post market tasks for Switzerland.
Indication of the importer on MDD and MDR medical devices – In respect of the obligation to mention the Swiss importer on the product labelling, Swissmedic has determined that it would provisionally, i.e. until the EU practice becomes known or, unless specified by the EU, until 31 July 2022, not require the CH-importer to be stated on medical devices compliant under the former MedDO legislation (enforcement moratorium period).
After negotiations with the Swiss Med Tech representatives and in order to mitigate the logistic costs for the importers, Swissmedic has agreed to allow, for MDD and MDR products, the indication of the importer to be listed on the delivery note/packing slip, so that a declaration directly on the product, packaging, or instructions for use is no longer obligatory. Again, it is unclear whether this compromise solution is acceptable for all European manufacturers and the deadlines can be respected.
Placement on the market and transitional periods – Under the revised MedDO, placing on the market means making available on the Swiss market for the first time, i.e. placing on the market in Switzerland for the first time (art. 4 para. 1 lit. b MedDO). Swissmedic has defined the concept of placing on the market as “making available for the first time (…) e.g. via a transfer or supply between economic operators or from a Swiss economic operator to a healthcare facility/the consumer” (Information Sheet Obligations of economic operators CH, https://www.swissmedic.ch/swissmedic/en/ home/medical-devices/market-access/pflichten-bevollmaechtigte.html).
Having said that, it is contentious whether this concept does also apply to the MDD medical devices placed on the market before 26 May 2021, for which transitional distribution deadlines apply (art. 101 MedDo), as claimed by Swissmedic. In this case, it can be argued that EU and EEA manufacturers that first put the medical devices in the distribution chain in EU/EEA countries, and not delivered them directly to the Swiss distributors, are no longer permitted to distribute their fully compliant and lawfully released MDD medical devices in Switzerland. This was most likely not the intention of the Swiss legislator when enacting transitional provisions for medical devices compliant with the “old legislation”, but the current missing guidance by the Swiss regulatory authorities is putting the EU and EEA manufacturers and their Swiss distributors under pressure.