On 19 May 2021, the Federal Council approved supplementary provisions to the implementing regulations on medical devices. These enter into force on 26 May 2021, at the same time as the completely revised Medical Devices Ordinance (MedDO) and a new Ordinance on Clinical Trials with Medical Devices (CTO-MedD). In the context of aligning Swiss medical devices legislation to the new EU Medical Device Regulations MDR and IVDR, the MRA (Mutual Recognition Agreement) also needs to be updated so that barrier-free market access and joint surveillance can be ensured. However, the EU Commission is making the updating of the MRA subject to progress being made with the Institutional Agreement and is only prepared to negotiate on transitional provisions for medical devices covered by the old legislation.
Modification of the Medical Devices Ordinance (MedDO) in the context of pending agreements between Switzerland and the EU
Since 2001, Switzerland has regulated medical devices in the same way as the EU and has been integrated in the European market surveillance system and European internal market for medical devices via the MRA. To improve the quality and safety of medical devices – and hence also to increase patient safety – the EU has tightened the requirements for medical devices across Europe. Switzerland, too, has completely revised its medical devices legislation so that it closely approximates to the new EU provisions.
Owing to the COVID-19 pandemic, the EU postponed the full implementation of the European Medical Device Regulation (MDR) by a year, to 26 May 2021. Switzerland has adapted its legal framework for medical devices in order to retain the existing equivalence between Swiss and EU medical device legislation. The legal provisions for in vitro diagnostic medical devices, for which the EU has also approved stricter regulation by way of the IVDR (In Vitro Diagnostic Medical Device Regulation), are still being adapted.
In parallel, the Switzerland-EU agreement on the mutual recognition of certificates of conformity (Mutual Recognition Agreement, MRA) also needs to be updated. It has not yet been possible to complete the updating of this agreement because it has been linked by the EU to progress made with the Institutional Agreement (InstA).
The supplementary provisions on the completely revised MedDO that were approved by the Federal Council on 19 May 2021 are designed to offset the negative consequences of the absence of the MRA update and ensure that the Swiss population is sufficiently supplied with safe medical devices.
Amendment to the MedDO – transitional provisions
The lack of an updated MRA affects the mutual market access to – and trading of – medical devices, coordinated market surveillance activities and the sharing of information between authorities or the mutual recognition of certificates of conformity.
The market surveillance of medical devices in Europe is based on the extensive sharing of information within the European network of regulatory authorities. Without an updated MRA, Swissmedic will continue to be denied official access to the central European database for medical devices (EUDAMED 3), which has been available since 1 December 2020. Swissmedic is excluded from the working groups on the joint surveillance of new medical devices and does not have access to implementation-related data.
By 26 May 2021, the Federal Council approved an amendment to the MedDO on 19 May 2021 that supplements the revised medical devices legislation. This amendment defines various measures and transitional periods designed to ensure that Switzerland continues to be supplied with safe medical devices and to offset the negative effects on market surveillance.
For example, the provisions allow unilateral market access to medical devices certified in the EU according to the new Regulation and thereby alleviate supply problems in Switzerland. Supplementary requirements such as the registration of economic operators with Swissmedic, the continuous reporting of serious incidents to Swissmedic and the establishment of an authorised representative for manufacturers outside Switzerland are intended to enable Swissmedic to maintain its surveillance system despite its exclusion from the EU authorities’ monitoring network.
In the absence of an updated MRA, Swiss manufacturers are already required to appoint an authorised representative in the EU for their products as of 26 May 2021. To avoid jeopardising a sufficient supply of medical devices to Switzerland, the Federal Council has set lengthy transitional periods of over one year in most cases.
The transitional provisions also affect registration and reporting obligations in particular: owing to the lack of access to EUDAMED3, economic operators (manufacturers, importers and authorised representatives) must register with Swissmedic and obtain a unique identification number ("Swiss Single Registration Number" CHRN). Swissmedic is already able to issue CHRNs as of 26 May 2021.
Registration of medical devices on the Swiss market at a later date is also planned.
In the absence of access to EUDAMED3, serious incidents and safety reports will still need to be reported to Swissmedic.
The period between the approval of the amendment to the MedDO (Federal Council decision) and the entry into force of the ordinances is very short. Wherever possible, Swissmedic has revised processes and documents in advance and is making these available from 26 May 2021.
As of 26 May 2021, the existing MedDO is being terminated and the documents relating to the old law are being replaced by new versions on the Swissmedic website. Changes and newly available documents will be communicated continuously. In view of the large number of documents and the short preparation time between the approval and entry into force (one week), delays may occur in individual cases, particularly for the various language versions (not all specification documents will be available in all languages at the same time).
Implementation of the new Swiss medical devices legislation
As part of the alignment of Swiss medical devices legislation to the new EU MDR, Swissmedic has already implemented the following changes:
As of 1 May 2021, applications for clinical trials of medical devices are already being processed according to the new law.
As of 26 May 2021, export certificates (FSC) for medical devices are issued only according to the new law, and export certificates (FSC) according to the old law are no longer possible.