Authorized Representative & Importer

5 Steps to Get Your Unique Authorized Representative and Importer

1. Fill out the

2. Accept quote

3. Draft and approve contract

4. Review of Technical Documentation by QUNIQUE

5. Register to Competent Authority by QUNIQUE & Successful cooperation

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The revised Swiss MedDO and IvDO require a Swiss Authorized Representative (Swiss AR) for all manufacturers based outside of Switzerland to place medical devices on the Swiss market.

Similarly, the EU MDR and IVDR require an EU Authorized Representative (EU AR) for manufacturers outside of the European Union to place medical devices on the European market.

In both cases, the assignment of the Authorized Representative has to be documented and signed by both the assigning and the assigned party.
The Swiss AR and the EU AR shall have permanently and continuously at their disposal at least one person responsible for regulatory compliance. The responsibilities of this person are defined in article 15 of the MDR and IVDR.

The essential duties of the

Swiss/EU Authorized Representative and Importer

are the following:

AR: Verification of
compliance with
registration requirements

Importer: Verification of CE Mark, Legal Manufacturer and Authorized Representative, Labelling and IFU

AR: Keeping available a copy of the technical

Importer: Keeping available Declarations of Conformity and CE Certificates

AR: Support of the authorities
during audits and
product tests

Importer: Co-operate with Competent Authorities and Notified Body

AR: Reporting of incidents
and complaints
(Vigilance Report)

Importer: Maintain complaints and traceability registers


Overview of MedDO/IvDO articles addressing Swiss AR and references to MDR/IVDR


  • Duties of the authorised representative                  (Art.51 MedDO), (Art.44 IvDO)
  • Person responsible for regulatory compliance (Art.52 MedDO, Art. 45 IvDO), referencing Article 49 (MedDO) and Article 42 (IvDO), Paragraphs 2 – 4
  • Registration of manufacturers, authorized representatives and importers (Art.55 MedDO, Art. 48 IvDO)
  • Product information (Art.16 MedDO, Art.15 IvDO)

Reference to MDR

  • Art. 11 Authorised representative
    Art. 12 Change of authorised representative
  • Art. 15 Person responsible for regulatory compliance


  • Electronic system for registration of economic operators (Art. 30 MDR, Art. 27 IVDR Paragraph 3)
    Registration of manufacturers, authorized representatives and importers (Art.31 MDR, Art.28 IVDR)
  • Annex I, chapter III

MRA and Authorized Representatives

For products with a conformity assessment according MDR the Contingency MedDO is now in effect and Manufacturers need a local Representative, since Switzerland and the European Union failed to come to on agreement regarding the Mutual Recognition Agreement (MRA) on   May 26, 2021.

Products with conformity assessment according to MDR/IVDR

For Swiss manufacturers placing their product on the EU market, an EU representative will be required from:

May 26, 2021 all medical devices

For EU manufacturers placing their product on the on the Swiss market, a Swiss Representative will be required from:


July 31, 2022 Class I, systems and procedure packs

March 31, 2022 Class IIa/IIb non-implantable devices

Dec 31, 2021 Class IIb/III implantable devices, active implantable devices


July 31, 2023 Class A 

March 31, 2023 Class B and Class C

Dec 31, 2022 Class D


If the manufacturer does not comply with his obligations according to the MedDO, IvDO, MDR and IVDR, the AR is jointly and separately liable with the manufacturer for defective products (Art.11 (5), IVDR and MDR).

They are obliged to have sufficient financial cover for damages caused by defective medical devices.


* Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices Last modification: April 24, 2020
* Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices
* Medical Devices Ordinance (MedDO) and Invitro Diagnostic Ordinance (IvDO)