On 4 May 2022, the Federal Council adopted the new Ordinance on In vitro Diagnostic Medical Devices (IvDO) and the amendment to the Ordinance on Clinical Trials with Medical Devices (CTO-MedD). The aim of the new regulations is to improve patient safety by means of stricter requirements for conformity assessment and post-market surveillance. The new legal requirements enter into force on 26 May 2022, at the same time as the application of the IVDR in the EU. From 26 May 2022, clinical trials with in vitro diagnostic medical devices will be regulated in the Ordinance on Clinical Trials with Medical Devices (CTO-MedD) and no longer in the Ordinance on Clinical Trials (ClinO).
Entry into force of the new Ordinance on In vitro Diagnostic Medical Devices (IvDO) and amendment of the Ordinance on Clinical Trials with Medical Devices (CTO-MedD)
Since 2001, the regulation of medical devices in Switzerland has been equivalent to that in the EU. In the context of the updating of medical devices legislation, the Mutual Recognition Agreement (MRA) would also need to have been updated in order to guarantee barrier-free mutual market access and a common surveillance system in Switzerland and the EU. In the absence of this updating, the same "third country rules" that have applied to other medical devices for a year will now also apply to in vitro diagnostic medical devices.
Situation in the EU
Proper implementation of EU Regulation 2017/746 on In Vitro Diagnostic Medical Devices (IVDR) could not be guaranteed by its date of application on 26 May 2022 due to the challenges of the COVID-19 pandemic, the limited capacities of the notified bodies (conformity assessment bodies) and the complexity of the Regulation itself. Therefore, on 25 January 2022, the EU adopted "Regulation (EU) 2022/112 amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and the deferred application of conditions for in-house devices". With these transitional periods, graduated by risk class and lasting until 2027 at the latest, the EU aims to prevent a threatened shortfall in supply.
Transitional provisions in Switzerland
These new transitional periods in the EU have also been taken into account accordingly in the Swiss Ordinance on In Vitro Diagnostic Medical Devices (IvDO). The IvDO additionally stipulates various transitional periods and measures designed to ensure that Switzerland continues to be supplied with safe in vitro diagnostic medical devices and to limit the negative consequences of failure to update the MRA on surveillance.
In particular, the provisions allow for the unilateral recognition of EU certificates of conformity, so that supply problems associated with in vitro diagnostic medical devices can be reduced in Switzerland. Supplementary requirements such as the registration of economic operators, the reporting of serious incidents to Swissmedic, and the establishment of a "Swiss authorised representative" (CH-REP) for foreign manufacturers will help enable Swissmedic maintain its market surveillance system despite its exclusion from the network of EU authorities.
To avoid jeopardising a sufficient supply of medical devices to Switzerland, the Federal Council has set lengthy transitional periods – over one year for most devices – for designating the CH-REP. The transitional provisions also affect registration and reporting obligations in particular.
Owing to the lack of access to the European database EUDAMED3, Swiss economic operators (manufacturers, importers and authorised representatives) must register with Swissmedic and obtain a Swiss Single Registration Number (CHRN). Registration with Swissmedic for the issuing of the CHRN was initiated as early as 26 May 2021 for medical devices.
Registration of medical devices, incl. IvD medical devices, on the Swiss market is planned at a later date.
In the absence of access to EUDAMED3, serious incidents and safety reports will still need to be reported to Swissmedic.
From 26 May 2022, the documents relating to the old law will be replaced by new versions on the Swissmedic website. Changes and newly available documents will be added continuously. Because very many documents are affected, and in view of the short period of three weeks between adoption and entry into force of the new legal requirements, delays may occur in individual cases.
Simplification of mandatory labelling in connection with third country requirements
The IvDO is designed to simplify the mandatory labelling for all devices handled by professionals, i.e. not those intended for self-use, and placed on the market in accordance with the new law. For these devices, the details of the CH-REP may, until 31 March 2025, alternatively appear on a document accompanying the device (e.g. a delivery note).
Bundesrat erhöht Sicherheit von In-vitro-Diagnostika
The FOPH makes the adjustments to Swiss medical device legislation on behalf of the FDHA.
The State Secretariat for Economic Affairs, SECO, is responsible for the MRA negotiations and export-related issues: