Verifying manufacturer has completed registration obligations in Switzerland.
Having a Person Responsible for Regulatory Compliance (PRRC).
Keeping available a copy of DoC, TD and certificate for Swissmedic.
Submit the documentation directly to Swissmedic on request, within 7 days of Swissmedic’s request.
Cooperating with Swissmedic on preventive and corrective actions during audits and/or requests.
Ensuring vigilance duties for incidents and complaints.
What is a Swiss Authorised Representative (SAR)?
In accordance with definition in Article 4 §1(g) of the revised Swiss MedDO, a Swiss Authorised Representative for a foreign medical device manufacturer corresponds to:
“any natural or legal person established within Switzerland who has received a written mandate from a manufacturer located in another country to act on the manufacturer’s behalf in relation to specified tasks with regard to the latter’s obligation under this Ordinance”.
Having a written mandate, this natural or legal person based in Switzerland becomes the representative of the foreign manufacturer according to the Swiss competent authority, Swissmedic, the SAR is legally liable for defective devices, on the same basis and jointly and severally with the manufacturer.
What types of Devices are included?
The Swiss Authorised Representative is required under the revised MedDO for:
All medical devices, including custom-made devices and products without a medical purpose listed in Annex 1 of the revised MedDO, but excluding in-vitro diagnostic medical devices, which are not concerned by the revised MedDO (see also: What requirements apply to in-vitro diagnostic medical devices (IVD)?),
Procedure Packs, as defined in Article 2(10) of the EU MDR, and
Systems, as defined in Article 2(11) of the EU MDR,
Which are placed on the Swiss market, within the meaning of Article 4 §1(b) of the revised MedDO.
Note: that the requirement applies equally to devices placed on the market in compliance with the EU MDR and to “legacy devices” that may remain on the market in compliance with the former MDD/AIMD.
What are the UDI / EUDAMED requirements?
EUDAMED IS not accessible to Swissmedic as the competent authority of a “third country” for the effects of the EU MDR, the registration of UDI core data elements required under Article 29 of the EU MDR will be implemented in Switzerland via the country-specific medical device information system, according to Article 67c of the Swiss Therapeutic Product Act (TPA, SR 812.21).
However this system is still under development. The details of such registration will be governed per the yet-to-be-enacted Article 17 §5 in the revised MedDO. Currently it is not known when and how the Swiss medical device information system will be implemented.
The name and address of the authorised representative must appear adjacent to the symbol. The address must enable contact to be established with the Swiss authorised representative. It is not sufficient only to state the P.O. box number, an e-mail address or a telephone number.
For legacy devices, the Swissmedic’s information sheet of 17.06.2021, it is explicitly indicated that the Swiss Authorised Representative’s particulars are not required on the instructions for use, the device itself, or in the documents enclosed with the product (delivery note, commercial invoice). Those particulars (name and address) only needs to appear on the device packaging, which is regarded as the outer packaging of the unit of sales.
Foreign manufacturer are not eligible for the defined “grace periods” in Article 104a of the revised MedDO, if they are located outside EEA (which now includes the United Kingdom) who have not already appointed a EU Authorised Representative.
In this case, the need for a Swiss Authorised Representative applied from 26 May 2021.
For EEA-based manufacturers, and manufacturers outside the EEA with a EEA-based EU Authorised Representative, the following “grace periods” for the appointment of a Swiss Authorised Representative are applciable:
Class III & class IIb implantable devices: 31 Dec 2021.
Class IIa& class IIb non-implantable devices: 31 March 2022.
Class I medical devices, Procedure Packs and Systems: 31 July 2022.
There are no differences in “grace periods” between EU MDR and MDD/AIMD “legacy devices”.