UPDATE 31/05/2021
Since 26 May 2021, with the full application of the Medical Device Regulation MDR (EU) 2017/745 and in the absence of an institutional agreement reached, Switzerland is officially considered a “Third Country” for Europe.
This means that Swiss Manufacturers must appoint a European Authorised Representative to export their devices to Europe. At the same time, European Manufacturers must designate a Swiss Authorised Representative to export their products to Switzerland, in compliance with the Medical Device Ordinance (MedDo).
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No agreement between Switzerland and the EU
The institutional agreement between Switzerland and the EU has not been reached because the Mutual Recognition Agreement (MRA) has not been updated, which is one of the essential prerequisites for the barrier-free trade in goods, because according to the Swiss Federal Council, there remain substantial differences between Switzerland and the EU that make it necessary to stop negotiations with the European Union. Despite this, Associations and Regulatory Authorities will continue to work with unwavering commitment to ensure that the MRA is updated as quickly as possible and that Switzerland’s relations with the EU are once again ensured a solid and lasting foundation.
In the meantime, Medical Devices placed on the Swiss market must comply with the MedDo, (modified in May 2021) which introduces numerous requirements.
MedDo Medical Device Requirements
Among the numerous requirements to be met there is, for example, the one that provides that the Manufacturer and the Authorised Representative may contractually agree that the technical documentation is not kept available in copy at the Authorised Representative, but transmitted, upon request, directly to Swissmedic by the Manufacturer (Art. 51 3bis). Furthermore, within three months of the first placing on the market of a device, it is necessary to register in the Swissmedic database (Art. 55).
As for the affixing of the UDI, Art. 104 establishes that the UDI (Art. 17 paragraph 2) must be affixed:
a. from 26 May 2021 for implantable devices and class III devices;
b. from 26 May 2023 for devices of classes IIa and IIb;
c. from 26 May 2025 for class I devices;
d. 2 years after the dates indicated in letters a – c for the corresponding class of devices for reusable devices subject to direct marking (affixing to the device itself).
Art. 104a provides for transition periods for the designation of a Swiss Authorised Representative. If the Manufacturer is based in an EU or EEA (European Economic Area) State or has mandated a person based in an EU or EEA State, it must designate a Swiss Authorised Representative for all devices that have been placed on the market after the May 26, 2021, within the following deadlines (Art. 51 paragraph 1):
- 31 December 2021 for class III devices, class IIb implantable devices and active implantable devices.
- 31 March 2022 for class IIb non-implantable devices and class lla devices.
- 31 July 2022 for class I devices.
For systems and procedural kits, the designation of a Swiss Authorised Representative must take place by 31 July 2022 (Art. 51 paragraph 5).
Do you market Medical Devices in Switzerland?
If you market Medical Devices in Switzerland, Thema expertsare ready to provide you with the right support with the following services:
- EU Authorised Representative
- Swiss Authorised Representative
- Device registration in the Swissmedic database
- Device registration in Eudamed (Actors module) and European Ministries of Health
PUBLISHED 17/02/2021
Without an agreement, Switzerland will probably become a Third Country in the Medical Devices sector.
We are with bated breath for the outcome of the bilateral agreements between Switzerland and European Union, currently being negotiated, relationships that could also significantly affect Operators that market Medical Devices in Switzerland.
Without an updated MRA, Switzerland will probably become a Third Country
Indeed, it exists the possibility that Switzerland will become a Third Country, at least for a short time, requiring the appointment for an Authorised Representative, just as happened in Great Britain after Brexit.
It is in fact in question the renewal of bilateral agreements between Switzerland and European Union, including the Mutual Recognition Agreement (MRA).
Currently, it seems impossible to sign a new MRA agreement – that would allow the harmonisation of the Swiss regulatory system to the Medical Device Regulation MDR (EU) 2017/745 – in how much since 2018 it has not been renewed the wider InstA Institutional Agreement which favoured the free movement of individuals, air transport, the transport of goods and passengers by rail and road, trade in agricultural products and mutual recognition of standards.
In other words, with the refusal of the InstA, it is not possible to renew the MRA agreement, with consequent impossibility of adaptation of Switzerland to the Medical Device Regulation MDR (EU) 2017/745, unless a new agreement is found between Switzerland and the EU.
Will Switzerland be able to align itself with the new MDR or will it become a Third Country?
It is still uncertain the outcome of the Switzerland- EU negotiations. All we know is that in Brussels, they are taking place meetings between Livia Leu Agosti, the new State Secretary of the Federal Department of Foreign Affairs (FDFA) and Stéphanie Riso, Deputy Head of Cabinet of Ursula von der Leyen.
What could be the possible future scenarios and the consequences for Medical Device Operators?
- The MRA agreement shall be updated by 26 May 2021: Switzerland would adhere to the MDR (EU) 2017/745 in good time and it would not be necessary the appointment of an Authorised Representative based in Switzerland or a European Authorised Representatives for Manufacturers based in Switzerland. In this case, any MDR-compliant device could circulate freely in the EU and Switzerland.
- The MRA agreement is updated after the date of application of the MDR Regulation. In this case, in the period between 26 May 2021 and the update of the agreement, the European Union could consider Switzerland as a Third Country and Switzerland could consider EU Member States as foreign countries according to the new Ordinance on Medical Devices (MedDO). This scenario seems to be the most likely. In this scenario, it would be provisionally necessary the appointment of a Swiss Authorised Representative for all Manufacturers based outside Switzerland which want to continue or start placing their Medical Devices on the Swiss market and, consequently, it should be appointed a European Authorised Representative for Manufacturers based in Switzerland.
- MRA is not updated or cancelled: Switzerland would remain a Third Country and it probably would define its own Regulation on Medical Devices, not aligned to the MDR. This would make the appointment of a Swiss Authorised Representative mandatory for all Manufacturers based outside Switzerland which want to continue or start placing their Medical Devices on the Swiss market and, consequently, it should be appointed a European Authorised Representative for Manufacturers based in Switzerland.
How to best prepare if Switzerland becomes a Third Country under the EU MDR Regulation?
Thema Staff continues to monitor the situation communicating in good time the developments on the next regulatory framework, which could lead Switzerland to become a Third Country for the EU.
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Sources:
Switzerland – EU MRA Agreement
Ordinance on Medical Devices (MedDo) (Link is in German)
