1. Definition "Swiss Authorised Representative" / "CH-REP"

A "Swiss Authorised Representative" / "CH-REP" is a natural or legal person established in Switzerland who is mandated in writing by a manufacturer established abroad to perform certain tasks on his behalf in fulfillment of obligations of the manufacturer arising from this Ordinance.

2. Main tasks / duties of the "Swiss Authorised Representative

  1. Ensure that the EU Declaration of Conformity and the technical documentation have been drawn up and are kept up to date, and that the MANUFACTURER has carried out an appropriate conformity assessment procedure;
  2. Compliance with registration requirements and verification that the MANUFACTURER complies with the registration requirements (incl. UDI system - Unique Device Identification System);
  3. Forwarding any requests from Swissmedic, for samples or for access to a product to the MANUFACTURER and verifying that Swissmedic receives the samples or access to the product;
  4. Responsibility for reporting serious incidents related to the product concerned that have occurred in Switzerland as soon as he or she becomes aware of them and field safety corrective actions taken in Switzerland. Exceptions to this reporting obligation, the modalities, the communication of periodic collective reports, the reporting of trends and the analysis of serious incidents and safety corrective measures in the field are governed by SR 812.213 Medical Devices Ordinance MepV;
  5. Submission of trend reports regarding incidents in Switzerland to Swissmedic;
  6. Cooperate with Swissmedic on any preventive or corrective measures to avert or, if this is not possible, mitigate hazards associated with products;
  7. Ensure that the MANUFACTURER sends the technical documentation directly to Swissmedic within seven days of Swissmedic's request;
  8. Promptly inform the MANUFACTURER of complaints and reports from healthcare professionals, patients, and users of suspected incidents involving a product for which the Authorized Representative has been designated;
  9. Termination of the mandate if the MANUFACTURER breaches its obligations under this Ordinance. In this case, the authorized representative shall immediately inform Swissmedic, as well as, if applicable, the Notified Body that participated in the conformity assessment of the product, of this termination and the reasons for it;
  10. The AUTHORITY shall have permanent and ongoing access to at least one person who has the requisite expertise in the requirements for medical devices under this Regulation and who is responsible for compliance ("Person Responsible for Compliance" / PRRC).

3. Selection and appointment of the "Swiss Authorised Representative

The following points must be taken into account when appointing the "Swiss Authorised Representative":

  • The transition periods according to SR 812.213 Medical Devices Ordinance MepV, as of 22.05.2021, apply.
  • The "Swiss Authorised Representative" must check whether the role may be assumed or whether it must be rejected before assuming its role as "Swiss Authorised Representative".
  • In the SR 812.213 Medical Devices Ordinance MepV, as of 22.05.2021, it is defined that the "Swiss Authorized Representative" does not have to keep a copy of the technical documentation available ("the manufacturer and the authorized representative may contractually agree that instead of keeping a copy of the technical documentation available at the Swiss Authorised Representative, the manufacturer shall deliver the documentation directly to Swissmedic upon request. The Swiss Authorised Representative must ensure that the delivery to Swissmedic takes place within seven days").
  • The foreign manufacturer must agree to the mandate in writing with the "Swiss Authorised Representative".
  • The "Swiss Authorised Representative" can only represent medical devices that are CE marked.

4. Services - Overview

4.1 General Information - Our Claim aims to provide tailor-made, compliant and useful services to both foreign manufacturers and importers and distributors in Switzerland.

  • is offered by selected and experienced consultants in the medical device industry.
  • It is of great concern to us that good, attractive and affordable medical products from foreign manufacturers continue to be available in Switzerland. We want to keep the additional efforts as low as possible to all participants according to various economic factors while at the same time fulfilling all regulatory requirements. Our functioning healthcare system depends on this!
  • The operators of are your direct contractual partners. Through, the know-how, availability and accessibility as well as the substitution and continuity are ensured.

4.2 Services for foreign manufacturers

The CH-REP is appointed by the foreign manufacturer as the Swiss Authorised Representative. The following steps will provide the path to designation:

The foreign manufacturer contacts the potential CH-REP at In order to be able to prepare a quotation, at least the following information is required:
- Product overview, product classification according to (EU) 2017/745
- Number of technical documentations per product class
- Number of GMDN codes

The possible CH-REP prepares an offer based on the information provided by the foreign manufacturer.

The foreign manufacturer checks the offer, clarifies the open points / questions with the possible CH-REP and decides to cooperate with the CH-REP.

The foreign manufacturer shall provide the designated CH-REP with the following documents regarding the company and the quality management system:

- Completed document "Self-assessment by the foreign manufacture" including the necessary documents.
- Annex I – List of required documents – General Information

The foreign manufacturer shall provide the designated CH-REP with the following documents regarding products / technical documentation:

- Medical devices of class I, which are not classified higher: entire technical documentation according to (EU) 2017/745.
- Class I medical devices which are not classified higher and all other medical devices: Annex II
- List of required documents
- Technical Documentation (per product)

The document transfer takes place under the responsibility and according to the specifications and possibilities of the foreign manufacturer. We provide a Dropbox transfer folder.

The designated CH-REP reviews the documents transferred by the foreign manufacturer, clarifies the open points / questions with the foreign manufacturer and decides whether the designation by the foreign manufacturer is possible.

The designated CH-REP prepares the contract together with the applicable annex documents (Annex I - Medical Devices, which are part of the contract; Annex II - Communication_Contact Data; Annex III - Compensation Agreement for the Provision of Services; Annex IV - Notification of Change to the Swiss Authorized Representative).

The designated CH-REP sends the contract together with the applicable annex documents to the foreign manufacturer for signature.

Once the contract is signed, the mandate is reported to Swissmedic (Swiss authority) by the "Swiss Authorised Representative".

The CH-REP informs the foreign manufacturer about the notification of the mandate. From this point on, the medical devices can be delivered to Switzerland (taking into account the obligations according to the contract and the affixing of the addresses of the CH-REP). Communication_contact details; Annex III - Compensation agreement for service provision; Annex IV - Notification of change to the Swiss authorized representative).

The designated CH-REP sends the contract together with the applicable annex documents to the foreign manufacturer for signature.

The foreign manufacturer informs the CH-REP according to the contract.

The CH-REP fulfills its services according to the contract.


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