Swiss Authorities publish FAQ on Medical Devices

The Swiss Agency for Therapeutic Products – Swissmedic – has published on their website a Frequently Asked Questions section related to medical devices, which provides helpful guidance in understanding the Swiss legislation.

The FAQ addresses he following categories of questions:

General questions:

The definition of medical devices in Article 3 MedDO;
The limits of the definition of ‘medical device’, distinguishing between medical devices and categories of devices as medicinal products;
The main role of the Agency in the process for medical devices to “effective market surveillance” (Swissmedic, 2021).

Economic stakeholders:

The definition of economic stakeholders in Article 4 MedDO that are equivalent to economic operators under the MDR. The obligations of the economic stakeholders can be found in MedDO Article 46-50 for manufacturers, Article 53 for importers, Article 54 for distributors, Article 51-52 for Authorized Representative (AR);
The registration of economic operators (Article 55 MedDO) to acquire the CHRN.

Market access:

Classification of the device is performed under the sole responsibility of the manufacturer, while Article 15 MedDO refers to Annex VIII of the MDR;
Medical Devices Nomenclature, where reference is made to EMDN used under the MDR/IVDR;
UDI, where Article 17 includes the requirements, Article 65 the recording and Article 104 the timelines;
EUDAMED, where for the time being Swissmedic has no access;
PRRC: The PRRC and deputy PRRC of the manufacturer are required by Article 49, whereas the PRRC of the AR by Article 52. It should be noted that the PRRC of the AR is not required to be located in Switzerland and there is no clear restriction that the PRRC of the manufacturer cannot function as the PRRC of the AR;
Conformity assessment routes are described in Articles 21-29 MedDO, which are based on the MDR, while the designated bodies/certificates of conformity and the Declaration of Conformity are addressed in Articles 24-28 and 29 respectively;
Product information refers to labels and IFU and is based on the relevant Annex of the MDR;
Notification of medical devices with further information from Swissmedic for medical devices, IVD and devitalized human tissue;
Product registration will become applicable at a later date (Article 110 MedDO);
Making a device available on the market, placing it in the market and putting it into service are included in Section 2 of MedDO;
Exemption authorizations are possible under Article 22 MedDO.
Provisions governing special medical devices, including categories such as medical device software and custom-made devices.
Transitional provisions and timelines including timelines of MedDO and EU-MDR (Chapter 11 Section 2 and Article 120 respectively), stock items and information on EU MDR.
International agreements, particularly information on the MRA between Switzerland and the EU.

New regime for Switzerland

As of May 26, 2021, the MRA between Switzerland and the EU related to medical devices is no longer in force. Manufacturers are heavily affected by the impact of this development. Please find more information here.

Anna Karavasili

Regulatory Affairs Department

08/11/2021

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