Switzerland Authorised Representative

Switzerland Authorised Representative - www.omcmedical.com

Switzerland Authorised Representative

Switzerland Medical Device Regulations

Medical devices are regulated by : Swiss Agency for Therapeutic Product

Switzerland Medical Device Regulations - omcmedical.com

Manufacturer Responsibility

Mutual recognition agreement (MRA) between EU and Switzerland: Possible situations

Depending on the terms of MRA, this situation will exempt the manufacturer from EU member states from the Swiss Authorized Representative(AR) requirement. European AR will be accepted as same as Swiss ARs and vice versa. Manufacturers outside the EU and Switzerland will still need to appoint EU AR or Swiss AR.

This situation will require manufacturers from the EU and outside of the EU to appoint a Swiss AR. Between 26th May 2021 and the MRA update, Switzerland will be considered a third country for the EU during the transition period. MedDo will need to get updated suitable to the situation. Depending on the MRA status between EU and Switzerland and the manufacturer’s location, the manufacturer has to decide if they should appoint Swiss AR.

Swiss Authorised Representative

Role of Authorised Representative

Registration in EUDAMED

❑ Actors registration (Economic Operators)
❑ UDI/Devices registration
❑ Notified Bodies and Certificates
❑ Clinical Investigations and performance studies
❑ Vigilance and post-market surveillance
❑ Market Surveillance

Information in EUDAMED

Depending on the applicable directive, Eudamed2 contains data
a) On registration of manufacturers, authorised representatives, and
devices
b) Declaration of conformity
c) Justification of the classification according toAnnex IX
d) A copy of ISO certificate/Proof of QMS
e) Relating to certificates issued, modified, supplemented, suspended,
withdrawn, or refused
f) Obtained in accordance with the Medical DeviceVigilance System
g) Information of clinical investigations

Product Information

Latest update for Manufacturers in EU & Swiss

EU Manufacturer exporting to Swiss:
Need to appoint Swiss AR, update the labelling for MDR products & follow third country requirements

Timeline to appoint Swiss AR:

Manufacturers in EU & Swiss - omcmedical.com

Swiss Manufacturer Exporting to EU:

These requirements are subject to change depending on the MRA between EU and Switzerland.

How we assist you with this process?

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