Swiss Authorised Representative (CH-REP)
As your CH-REP, Certification Experts fulfils a pivotal role in market access in Switzerland.
- Intermediary between the manufacturer and competent national authorities within Switzerland
- Ensure registration in Swissdamed, the Swiss Database on Medical Devices
- 25 years of experience in product compliance
- 15+ experts are ready to help
A quick overview of this page
Trust AR Experts to be your Swiss Authorised Representative
What is a CH-REP?
A Swiss Representative (CH-REP) is a legal entity based in Switzerland that acts as an intermediary between a foreign Manufacturer and Competent Authority in Switzerland, SwissMedic.
This position is required for Manufacturers based outside Switzerland that wish to sell medical devices in Switzerland.
The CH-REP is mandated to perform specified tasks on Manufacturer’s behalf in relation to the latter’s obligations under the Swiss Medical Devices Ordinances.
Similar roles exist for the EU and UK markets; for example, an EU Authorised Representative (EC Rep/EU Rep) or a UK Authorised Representative (UKRP). AR Experts offers these positions as well.
What Does a CH-REP Take Care of?
The CH-REP acts as an intermediary between the Manufacturer and the Swiss Competent Authority.
Other responsibilities of the CH-REP are:
- To verify that the EC Declaration of Conformity, and the technical documentation have been drawn up and that an appropriate conformity assessment procedure has been carried out.
- Keeping the necessary documentation available to SwissMedic.
- To verify the actor and device registration information.
- Forwarding information from users and SwissMedic to the Manufacturer.
- Involvement in vigilance handling.
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What are the challenges of a Swiss Authorised Representative?
Switzerland has adopted the EU Medical Devices Regulations, although with the addition of instruments to embed the EU Regulations in Swiss legislation.
What is the CH-REP symbol or CH-REP logo?
When selling medical devices in Switzerland it is obliged to have a CH_REP symbol on the labelling (CH Rep Label).
The CH-REP symbol must be accompanied by the name and address of the Swiss CH Representative. Stating a P.O. box, e-mail address or telephone number is not sufficient.
What is the procedure for AR Experts to become your Swiss Authorised Representative?
Once you have decided to utilise our Swiss CH Representative services, it will be formalised in a Swiss Representative agreement. After signing, we expect to receive the technical documentation. Upon a successful verification of the technical documentation, we will notify the mandate to SwissMedic, and as such, we become your CH-REP.
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AR Experts offers the following services
Below you can see what role our experts play in ensuring that your product can safely and legally be sold on the EU market.
Authorised Representation
AR Experts (part of Certification Experts) can act as an authorised representative on behalf of your organisation and ensures that the products being sold on the EU and/or UK market comply with the applicable product compliance legislations. This concerns products that are sold either directly, via e-commerce (online), or through a fulfilment service provider.
We operate in various sectors, such as Machinery, Electronics, Medical Devices, Consumer Product, Toys, Personal Protective Equipment, Boats and more.
- EU Authorised Representative
- UK Authorised Representative
- EC Rep (Medical Devices)
- UK Repsonsible Person (UKRP)
- Responsible Person (RP) GDP
- Person Responsible for Regulatory Compliance (PRRC)
EC Rep
According to the Medical Device Regulation (MDR (EU) 2017/745) and In Vitro Diagnostic Medical Device Regulation (IVDR (EU) 2017/746) you are obliged to appoint a European Authorised Representative (EC REP) if you want to trade your Medical Device(s) on the European market. AR Experts (part of Certification Experts) can act as an EC REP on behalf of your organisation.
- Aid in CE marking conformity assessment procedure
- Authorised representative agreement/mandate
- Technical file and Documentation review
- Acting as a contact person with the competent authorities
- Provide legal advice
- Registering the manufacturer’s devices in EUDAMED
UK Responsible Person (UKRP)
As of Brexit, the MHRA requires manufacturers who are based outside of the UK to assign a UK Responsible Person (UKRP). A UKRP is essentially an Authorised Representative UK for manufacturers of Medical Devices and will generally fulfil the same role in accordance with the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR). They are a registered legal party based within the UK that acts as a liaison between a manufacturer outside of the UK and the MHRA. UKCA Experts (part of Certification Experts) act on behalf of a manufacturer established outside of the United Kingdom as their UKRP.
- Aid in UKCA marking conformity assessment procedure
- UKRP agreement/mandate
- Technical file and documentation review
- Acting as a contact person with the competent authorities
- Providing legal advice
- MHRA Registration
All the answers you might need!
Without a Swiss Authorised Representative medical devices, medical devices can’t be legally placed on the Swiss market, and the Manufacturer would be in violation of Swiss law, which could lead to penalties, product recalls, or market access restrictions. The CH-REP medical device is only obligated for manufactures situated outside Switserland.
No, but Swiss Representatives and importers must register themselves (“CHRN”).
Yes. Manufacturers outside of Switzerland cannot legally enter the Swiss market without appointing a CH-REP medical device if their products fall under certain regulatory categories. A CH-REP may be required for various products.
The pivotal role of in-country representatives is to serve as a juridical instrument for the Competent Authorities to enforce law on the foreign Manufacturer.
An in-country representative acts in the context of law enforcement. The Manufacturer is outside the said jurisdictions. For the purpose of law enforcement, the in-country representative adopts the position of Manufacturer under the regulations.
SwissMedic is the national authorisation and supervisory authority for drugs and medical products. The agency ensures that only high-quality, safe and effective medical products are available in Switzerland, thus making an important contribution to the protection of human and animal health. SwissMedic’s functions are similar to those of the European Competent Authorities or the U.S. Food and Drug Administration (FDA) in the United States.
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