Authorized Representative

5 Steps to Get Your Unique Authorized Representative

1. Fill out the
questionnaire
& NDA
2. Review draft
contract by
customer
3. Review of Technical Documentation by QUNIQUE
4. Signed
contract
5. Successful cooperation

GERMANY
QUNIQUE GmbH
Ɯberseeallee 1, 20457 Hamburg

SWITZERLAND
QUNIQUE GmbH
Bahnhofweg 17, 5610 Wohlen

The revised Swiss MedDO requires 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 requires 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.

The essential duties of the Swiss AR and EU AR are the following:

Verification of
compliance with
registration requirements

Keeping available a
copy of the technical
documentation

Support of the authorities
during audits and
product tests
Reporting of incidents
and complaints
(Vigilance Report)

Overview of MedDO articles addressing Swiss AR and references to MDR

MedDO

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

Reference to MDR

  • Art. 11 Authorised representative
    Art. 12 Change of authorised representative
  • Art. 15 Person responsible for regulatory compliance
  • Art. 30 Electronic system for registration of economic operators, Paragraph 3
    Art. 31 Registration of manufacturers, authorized representatives and importers
  • Annex I, chapter III

MRA and Authorized Representatives

For products with a conformity assessment according MDR the Contingency MedDO will come into effect and Manufacturers will need a local Representative, if Switzerland and the European Union do not come to on agreement regarding the Mutual Recognition Agreement (MRA) until May 26, 2021.

Products with conformity assessment according to MDR

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

Liability

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

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

MedDO, MDR and IVDR

References/Bibliography
* 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)
* Swiss MedTech Information for the Swiss Medical Technology Industry Last modification: May 12, 2021
* Inmedis Transition Timelines MDR 2017/745
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