Swiss Authorised Representative (SAR)
Switzerland has revised its medical device legislation to align with the EU MDR (Reg. (EU) No. 2017/745) to have it apply simultaneously, on 26 May 2021 hence Switzerland has been considered as a third country status to the EU.
Under this revised version of the Swiss Medical Device Ordinance (MedDO, RS 812.213), manufacturers located outside of Switzerland are required to appoint a Swiss Authorised Representative (Swiss Rep) to sell their CE-marked devices in Switzerland. The absence of an updated Mutual Recognition Agreement between Switzerland and the EU to cover the EU MDR means that medical device manufacturers established in EU/EFTA countries also need a Swiss Rep under the revised MedDO.
As mutual recognition of conformity assessment procedures no longer appliesforeign manufacturers of medical devices in Switzerland must appoint an “Swiss Authorised Representative” (SAR).
A SAR is a natural or legal person established in Switzerland who is mandated in writing by a manufacturer abroad to perform certain tasks on his behalf in fulfilment of the manufacturer’s obligations arising from this Ordinance.
In order to simplify the process International Associates Limited has and agreement with CH-Rep.com to act as the SAR.
Manufacturers wishing to place product on the UK, EU and Swiss market can do so using as single point of contact who will manage all the technical file reviews and registration requirements.
Swiss Rep Responsibilities
Article 51 of the revised MedDO describing the Swiss Authorised Representative’s duties calls out Article 11 of the EU MDR on EU Authorised Representative and includes: -
- Verifying Declaration of Conformity (DoC), Technical Documentation (TD), device labeling, (conformity assessment).
- 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.
Labelling
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.
You can download the symbol here.
Timelines
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”.
Further Guidance
Guidance on the regulations for Switzerland here
Changing your Authorised Representative.
Changing your Authorised Representative is a fairly straightforward process. First of all, this change should appear in the agreement between the manufacturer and the Authorized Representative (Outgoing and incoming).
To be compliant, the manufacturer should address the following aspects:
The date of termination of the outgoing Authorized Representative and the date of start of the incoming one.
The date until which the manufacturer can show the outgoing AR on the information or promotional material.
The transfer of documents, including confidentiality aspects and property rights
The obligation to the outgoing Authorized Representative to send to the manufacturer or incoming Authorized Representative, any complaints or reports from healthcare professionals and patients or users about suspected incidents related to the device for which it has been designated.
Contact Us
For more information about Swiss Authorised Representative please contact us by using our contact form, by phone or drop us an email. We will be pleased to assist you.
Alternatively get a quote by filling in our enquiry form
