On 26 May 2021, the Medical Device Regulation (“MDR”) enters into force in the EU. As from that date, the Mutual Recognition Agreement (“MRA”) between Switzerland and the EU no longer applies to trade in medical devices. To avoid a ban on imports, the Swiss Federal Government on 19 May 2021 adopted contingency rules providing for a grace period and clarifying the rules that medical devices need to meet for continued import into Switzerland.
Manufacturers established in the EEA that have an authorized representative designated in the EEA and intend to import medical devices into Switzerland should take the following actions:
- appoint an authorized representative in Switzerland for all devices placed on the Swiss market after 26 May 2021, (i) by 31 December 2021 for class III devices, class IIb implantable devices and all active implantable medical devices, (ii) by 31 March 2022 for non-implantable class IIb devices and class IIa devices, and (iii) by 31 July 2022 for class Ia devices, systems and procedure packs;
- ensure that the labelling is adjusted by the time the new authorized representative is appointed;
- if they have already placed products on the market before 26 May 2021 in accordance with the MDR and IVDR, complete their registration of the pertinent information with Swissmedic by 26 November 2021;
- within three months of placing a product on the Swiss market for the first time, register the pertinent information with Swissmedic;
- make any other registration and notification as required, such as notification of the Unique Device Identifier (UDI), serious incidents in connection with the product concerned or field safety corrective measures taken in Switzerland, to Swissmedic;
- provide access to the technical documentation either by keeping a copy available at the authorized representative or by contractually guaranteeing that it will be handed over to Swissmedic upon request within 7 days;
- publish the validated Summary of Safety and Clinical Performance (SSCP), for example on its website.
In more detail
Since 2001, the MRA, which covers 60% of the trade in industrial goods between Switzerland and the EU, ensured the supply of safe and effective medical devices to Switzerland and guaranteed Swiss manufacturers equivalent access to the EU market. Due to various incidents involving the use of such products, Switzerland and the EU are tightening their respective requirements in this area as of 26 May 2021, with the aim of improving the safety of medical devices and the monitoring of the market by the authorities. Even though the adjustments to Swiss and EU medical device laws are aligned, the free market access would require updating the bilateral MRA. However, the EU so far opposed any amendment of the MRA due to the failing progress on the institutional framework agreement that Switzerland and the EU are negotiating and have not been able to conclude yet.
Based on a proposal from the European Commission, Switzerland and the EU have therefore held intensive discussions on possible transitional provisions for the MRA, including a grace period until 2024, but these talks have not yet led to an agreement, either.
The Swiss and European medical device industries are affected by the open outcome of these talks; they will have to cope with significant additional expenses due to the discontinuation of the trade facilitations of the MRA. Market surveillance in Switzerland is also negatively affected. Until now, it was carried out in close cooperation with the partner authorities of the EU, and Switzerland was involved in the respective exchange of information. Without updating the MRA, this cooperation will be limited and the assurance of patient safety will be weakened. Manufacturers from the EU will, most importantly, have to appoint an authorized representative in Switzerland as from 26 May 2021 and label the products with its information. The authorized representative is a proxy to the foreign manufacturer and is responsible for the product safety and liable for product defects in the same way as the manufacturer.
At its meeting on 19 May 2021, the Federal Council adopted measures to mitigate these negative effects and provided for transition periods that give industry more time to do so. The measures are thus intended to help ensure that Switzerland can continue to be supplied with safe and effective medical devices in an orderly manner. With the amendments adopted by the Federal Council, the equivalence of the Swiss provisions to those of the EU is maintained, which means that it will still be possible to update the MRA at a later date.
The amending decree to the Medical Devices Ordinance will enter into force as a supplement at the same time as the totally revised Medical Devices Ordinance adopted on 1 July 2020, so on 26 May 2021. This step will avoid regulatory gaps so that safe and effective medical devices can continue to be placed on the market and monitored in Switzerland.
As a result, European manufacturers will in future be required to appoint an authorized representative in Switzerland to represent the manufacturer in dealings with the Swiss authorities. If the manufacturer does not have a registered office in Switzerland and cannot assume responsibility for placing its products on the market through a subsidiary, it is required by law to appoint an authorized representative based in Switzerland. The same obligation also applies to Swiss manufacturers who wish to place medical devices on the market in the European Union: They must appoint an authorized representative domiciled in a member state of the European Union. The regulation of the Swiss authorized representative corresponds to that of the European authorized representative. In both cases, the appointment requires the conclusion of a written agreement (“mandate”).
Certificates issued by notified bodies under EU law that are domiciled in the EEA are treated as certificates issued by Swiss notified bodies if it can be credibly shown that (i) the conformity assessment procedures applied meet the Swiss requirements, and (ii) they are issued by a body with qualifications equivalent to those required in Switzerland.
Manufacturers or their authorized representatives and importers shall, within three months of placing a product on the Swiss market for the first time, register the required information in accordance with Annex VI, Part A, Section 1 of the EU MDR with Swissmedic. Any changes to the information must be notified to Swissmedic by the relevant economic operator within one week.