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Daniel Donauer
Pranvera Rasaj
Switzerland has comprehensively revised its regulation for medical devices and in vitro diagnostic medical devices in order to improve safety and quality and to align with EU regulations. Due to the failure to update the Mutual Recognition Agreement (MRA), Switzerland has been considered a third country in the area of medical devices since May 2021 and in the area of in vitro diagnostic medical devices since May 2022. In response to this, the swissdamed database was set up to ensure market surveillance and guarantee the supply of safe products in Switzerland.
1.—Overview
Switzerland has comprehensively revised its medical device legislation in close alignment with the EU regulations for medical devices (MDR1 and ICVDR2). The aim was to increase the safety and quality of medical devices. When the MDR came into force, Chapter 4 (medical devices) of the MRA3 should also have been updated. Due to a lack of progress on institutional issues between Switzerland and the EU, the European Commission has so far refused to update this chapter. Switzerland has therefore been considered a third country by the European Commission in the area of medical devices since May 2021 and in the area of in vitro diagnostic medical devices since May 2022 (date of application of the MDR and ICVDR). As a result of these steps, significant trade facilitations between Switzerland and the EU no longer apply. For example, the Swiss market surveillance authority Swissmedic was denied access to the European database for medical devices. In order to mitigate the effects of the lack of an update to the MRA, the Federal Council adopted fallback measures. These guarantee the supply of safe medical devices in Switzerland and ensure market surveillance.
2.—About swissdamed
In April 2022, Swissmedic launched the realization of the swissdamed – swiss database on medical devices. This database is intended to facilitate the implementation of Swiss regulations for medical devices and in-vitro diagnostics and provide an overview of the life cycle of medical devices available in Switzerland. The aim is for the database to integrate various electronic systems with which information on medical devices and the parties involved can be collected and processed. In principle, the aim is to increase transparency and improve access to information for the public and healthcare professionals.
Swissdamed is based on two modules that can only be accessed by registered users and a freely accessible search function. These are the Actors module: Registration of companies and economic actors, the Devices module: Registration of products and swissdamed: freely accessible platform with search function.
When economic operators are registered, Swissmedic assigns a Swiss Single Registration Number (CHRN). The CHRN is a unique Swiss registration number that Swissmedic assigns once at the request of the economic operators concerned and that enables unique identification. The CHRN is issued to Swiss manufacturers, authorized representatives and importers (in accordance with Art. 55 MedDO4 and Art. 48 IvDO5). Every Swiss economic operator concerned must register with Swissmedic and provide the required information.
3.—Legal basis in Switzerland
Since May 2021, Switzerland has been considered a third country by the European Commission in the area of medical devices and since May 2022 in the area of in vitro diagnostic medical devices. As a result, the MedDO and the IvDO have been revised. The relevant provisions for swissdamed are set out in Art. 55 MedDO and Art. 48 IvDO.
Without a functioning MRA, it is no longer possible to fully view the economic operators recorded in Eudamed who place a product on the Swiss market. Access is restricted to publicly accessible data. In order to nevertheless ensure market surveillance in Switzerland and minimize the consequences of the loss of information, manufacturers or their authorized representatives and importers must register once with Swissmedic. It is not necessary to register again when introducing further products.
While the EU MDR requires registration before placing on the market, the new MedDO regulation allows registration within three months of placing on the market. This additional period is intended to ensure that the placing of compliant products on the market is not hindered and to counteract a potential supply shortage in Switzerland.
According to the MedDO and IvDO, changes to the registration details must be updated in Eudamed by the manufacturer, authorized representative and importer within one week (7 days) of becoming aware of them. As access to Eudamed for Swissmedic is not guaranteed without a functioning MRA, these notifications must be made directly to Swissmedic.
The MedDO and IvDO stipulate that Swissmedic checks the information entered by the economic operators in Eudamed and notifies the relevant economic operators in Switzerland of the Single Registration Number (SRN) assigned by Eudamed. Without a functioning MRA, this verification is not necessary and no SRN can be assigned via Eudamed for economic operators based in Switzerland. Instead, Swissmedic assigns a Swiss unique identification number.
A similar regulation also applies to persons who assemble systems and treatment centers in accordance with Art. 11 MedDO and are considered economic operators in accordance with Art. 47 para. 4 TPA6. They must register their name and address with Swissmedic within three months of placing the product on the market. In this case, it is also important for market surveillance in Switzerland to have this data available.
With reference to Article 27 para. 3 and Article 28 EU-IVDR, further obligations and modalities regarding the registration of economic operators with Swissmedic are defined in accordance with the requirements of EU law. Importers must check within two weeks of placing a product on the market whether the manufacturer or its authorized representative has reported the required information to Swissmedic or entered it in the system for the registration of economic operators. Once the reported information has been verified, Swissmedic assigns the economic operator a unique Swiss registration number (CHRN).
4.—Implementation schedule
As already mentioned, Swissmedic does not have access to the European database Eudamed due to the lack of an update of the MRA with the EU. Swiss economic operators (manufacturers, importers and authorized representatives) must therefore register with Swissmedic since 26 May 2021 in order to obtain the “Swiss Single Registration Number” (CHRN). The next steps for implementing the introduction of swissdamed are as follows:
- July 26, 2024: Applications for registration and amendment of the CHRN as well as notifications of mandates will be accepted until July 26, 2024 (submission date) via PDF form (end of form); and
- August 6, 2024: “Go Live” of the Actors Module for the registration of economic operators.7
The data of the almost 3,700 economic operators who have already registered with Swissmedic and therefore have the CHRN will be migrated. The registered operators will be informed of the next steps by letter at the beginning of August via the contact person specified during registration. There is no need to register again.
The data of the almost 3,700 economic actors who have already registered with Swissmedic and therefore have the CHRN will be migrated. The registered operators will be informed of the next steps by letter at the beginning of August via the contact person specified during registration. There is no need to register again.
1 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (MDR).
2 Regulation (EU) 2017/746 of the European Parliament and of the Council of April 5, 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (ICVDR).
3 Agreement between the Swiss Confederation and the European Community on Mutual Recognition in relation to Conformity Assessment (MRA).
4 Medical Devices Ordinance (MedDO) of July 1, 2020.
5 Ordinance on In-vitro Diagnostic Medical Devices (IvDO) of May 4, 2022.
6 Federal Act on Medicinal Products and Medical Devices (Therapeutic Products Act, TPA) of December 15, 2000.
7 From then on, economic operators will be registered exclusively via the www.swissdamed.ch application.
