1. Manufacturers outside Switzerland will need to appoint Swiss AR.
2. The Manufacturer will use commercially reasonable efforts to update its technical
documentation for the devices, to comply with the requirements of the ordinance, and to complete a conformity assessment procedure for devices in due time prior to the expiration of their current certificate of conformity.
3. The Manufacturer reserves the right but needs to inform AR about any discontinuities of the devices upon expiration of their current certificate of conformity.
4. As per the latest application of the ordinance, for all devices made available on the Swiss market, the manufacturer should ensure:
I. The device should be CE marked.
II. The technical documentation and the declaration of conformity of the device has been drawn up.
III. Requesting Swissmedic for the Swiss Single Registration Number (CHRN), which is used to identify the manufacturer, authorised representative, or importer and is will also need to register in the EUDAMED database issuing the Single Registration Number (SRN).
IV. Labelling of the device in accordance with the ordinance accompanied by the required Instructions For Use (IFU).
V. Assigning UDI to medical devices before placing them in the market and reporting to Swissmedic.
VI. Establishment of a post-market monitoring system and defined necessary corrective measures.
VII. Maintenance of the quality management system.
5. Manufacturers should report serious incidents associated with their medical devices to Swissmedic and should also initiate a Field Safety Corrective Action (FSCA) monitored by Swissmedic for the medical devices placed on the market in Switzerland. FSCA is used to reduce risk of death or severe deterioration in the health of the end-user associated with the medical device and may include the return of a medical device to the supplier, device – modification, exchange, or destruction.
6. The Manufacturer will not delegate to the AR the obligations laid down in Articles 16 – 17, 46 – 47, 50, 56, and 66 of the ordinance. The corresponding obligations in the (EU) 2017/745 are Article 10 (1) – (4), (6) – (7) and (9) – (12).