menu 3

SWISS AUTHORISED REPRESENTATIVES FOR FOREIGN MANUFACTURERS OF IN VITRO DIAGNOSTIC MEDICAL DEVICES ACCORDING TO (EU) 2017/746 IVDR

1. Anfrage / Input für die Angebotserstellung

The foreign manufacturer contacts the potential CH-REP at ar@ch-rep.com. In order to be able to prepare an offer, at least the following information is required: - Product overview, product classification according to (EU) 2017/746 - Number of technical documentations per product class - Number of GMDN codes

2. Angebotserstellung

Der mögliche CH-REP erstellt aufgrund der vom ausländischen Hersteller zur Verfügung gestellten Informationen ein Angebot. 3. Entscheid des ausländischen Herstellers Der ausländische Hersteller prüft das Angebot, klärt mit dem möglichen CH-REP die offenen Punkte / Fragen und entscheidet sich zur Zusammenarbeit mit dem CH-REP.

3. Entscheid des ausländischen Herstllers

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

4. Dokumententransfer zur Vorprüfung

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 – IVDR
The foreign manufacturer shall provide the designated CH-REP with the following documents regarding products / technical documentation:
  • In vitro diagnostic medical devices of class A, which are not classified higher: entire technical documentation according to (EU) 2017/746.
  • In vitro diagnostic devices of class B to D, according to the checklist: Annex II - List of required documents-IVDR (per product) The document transfer is the responsibility and according to the specifications and possibilities of the foreign manufacturer. We provide a Dropbox transfer folder in each case.

5. Vorprüfung

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.

6. Vertragswesen / Benennung / Mandatierung

The designated CH-REP prepares the contract together with the applicable annex documents (Annex I - In Vitro Diagnostics , which are part of the contract; Annex II - Communication_Contact Data; 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.

7. Meldung des Mandats

As soon as the contract is signed, the mandate is reported to Swissmedic (Swiss authority) by the Swiss authorized representative. The CH-REP informs the foreign manufacturer about the notification of the mandate. From this point on, the in vitro diagnostic medical devices can be delivered to Switzerland (taking into account the obligations according to the contract and the attachment of the addresses of the CH-REP). Communication_contact details; 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.

Links:

Send us your request by email

You will receive prompt feedback.
ar@ch-rep.com

What is a Medical Device?

Infos CH-REP 12/22 Update

1. Definition "Swiss Authorized Representative" / SAR

A "Swiss Authorized 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 Authorized 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 he Manufacturer complies with the registration reqiurements (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 concerning that have occured in Switzerland as soon as he or she becomes aware of them and field safety corrective action taken in Switzerland. Execptions to thsi reporting obligation, the modalities, the communicationof periodic collective reports, the reporting of trends and the analysis of serious incidents and safety corrective measures in the field are governed by SR 312.219 In Vitro Diagnostics Medical Device Ordinance IvDO;
  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 Swiss Authorized Representative must have permanent and ongoing access to at least one person who has the necessary expertise in the requirements for in vitro diagnostic medical devices under this Regulation and who is responsible for compliance ("Person Responsible for Compliance" / PRRC).

3. Selection and appointment of the "Swiss Authorized Representative"

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

  • The transition periods according to SR 812.219 In Vitro Diagnostics Medical Device Ordinance IvDO as of 04.05.2022, 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 812.219 In Vitro Diagnostics Medical Device Ordinance IvDO as of the 04.05.2022, it is defined the the "Swiss Authorized Representative" does not have to keep a copy of the technical documentation available ("the manufacturer and the authorized representative may contracually agree tha instead of keeping a copy of the technical documentation available at the Swiss Authorized Representative, the manufacturer shall deliver the documentation directly to Swissmedic upon request. The Swiss Authorized representative must ensure that the delivery to Swissmedic takes place within 7 days.
  • The foreign manufacturer must agree to the mandate in writing with the "Swiss Authorised Representative".
  • The "Swiss Authorized Representative can only represent in Vitro Diagnostice medical devices that are CE market

4. Generel Information - our Claim

CH-REP.com aims to provide tailor-made, compliant and useful services to both foreign manufacturers and importers and distributors in Switzerland.

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

5. Services - Overview

The CH-REP is appointed by the foreign manufacturer as the Swiss authorized representative. 

The process to designation provides for the following steps:

The foreign manufacturer contacts the potential CH-REP at ar@ch-rep.com. In order to be able to prepare an offer, at least the following information is required: - Product overview, product classification according to (EU) 2017/746 - 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 – IVDR
The foreign manufacturer shall provide the designated CH-REP with the following documents regarding products / technical documentation:
  • In vitro diagnostic medical devices of class A, which are not classified higher: entire technical documentation according to (EU) 2017/746.
  • In vitro diagnostic devices of class B to D, according to the checklist: Annex II - List of required documents-IVDR (per product) The document transfer is the responsibility and according to the specifications and possibilities of the foreign manufacturer. We provide a Dropbox transfer folder in each case.
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 - In Vitro Diagnostics , which are part of the contract; Annex II - Communication_Contact Data; 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.
As soon as the contract is signed, the mandate is reported to Swissmedic (Swiss authority) by the Swiss authorized representative. The CH-REP informs the foreign manufacturer about the notification of the mandate. From this point on, the in vitro diagnostic medical devices can be delivered to Switzerland (taking into account the obligations according to the contract and the attachment of the addresses of the CH-REP). Communication_contact details; 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.

Links:

Contact form:

Do you have questions?

We will contact you if you send us a message.

Contact us by email at ar@ch-rep.com 

You will receive prompt feedback.

ar@ch-rep.com

What is a medical device?

de_DE
de_DE
Home
About us
Swiss Authorised Representative for Medical Devices
Schweizer Bevollmächtigter In-vitro-Diagnostika
Support for Swiss importers and distributors of medical devices
Support for Swiss importers and distributors of in vitro diagnostics
Transitional provisions for Medical Devices
Transitional provisions for In-Vitro-Diagnostika