Following the failure to achieve an institutional agreement between Switzerland and the European Union, Switzerland made the CH REP nominee compulsory. CH REP is a physical or legal person with registered office in Switzerland acting on behalf of Medical Devices Manufacturers based outside the Swiss territory.
WHY IS THE CH REP FIGURE NECESSARY?
The CH REP figure – Swiss Authorised Representative – it’s necessary if Manufacturers based outside the territory wanting to market their Medical Devices in Switzerland.
In this article we will give you some information about the transitional periods scheduled for the CH REP nominee and about Swiss Authorised Representative tasks.
From when is it necessary to nominate a CH REP?
Since May 26th, 2021, date of full application of MDR (UE) 2017/745 in Europe, Switzerland officially became a third country for Europe and the new Swiss regulation together with the revision of Ordinance MedDO SR 812.213 came into effect.
Such ordinance requires that Swiss Manufacturers appoint an European Authorised Representative to export their devices in Europe and, at the same time, European Manufacturers need to appoint a Swiss Authorised Representative, CH REP, to export their products in Switzerland.
Depending on Medical Device risk class, MedDO Article 104a requires different transitional periods and the CH REP has to be appointed in accordance with the following deadlines:
- By December 31st, 2021, for class III devices, class IIb implantable devices, and active implantable Medical Devices;
- By March 31st, 2022, for class IIb non-implantable devices and class IIa devices;
- By July 31st, 2022, for class I devices.
MedDO Article 51 paragraph 5 requires the following transitional period for the Swiss Authorised Representative nominee:
- By July 31st, 2022, for systems and procedure packs.
Informative sheet on Swiss Economic Operators obligations
On September 27th, 2021, the Regulatory Authority Swissmedic published the useful “Information sheet, Obligations Economic Operators CH” to clarify some aspects about MedDO which define requirements and responsibilities for Economic Operators involved in Medical Devices supply chain.
Specifically, the informative sheet focuses on the Swiss Authorised Representative, the Importer, the Distributor and their obligations. This document also refers to Medical Devices, their accessories, and devices with no intended medical use (mentioned in the informative sheet and defined in the Annex XVI MDR and the Annex I MedDO).RYou can find graphics and charts that exemplify the Authorised Representative, Importer, and Distributor obligations.
Finally, there is some information about roles that must be visible on the devices and where they need to be indicated (labels, IFU, packaging).
In this respect, we would like to remind you that Swissmedic has published on its website the CH REP symbol to be used to specify the Swiss Rep.
The Rep’s name and address need to be indicated very close to the symbol.
Some CH REP obligations
- Fulfilling the reporting obligations with Swissmedic.
- Taking, if needed, corrective actions on the field and adverse events.
- Respecting the post-market surveillance scheduled duties.
- Registering devices on Swissmedic database respecting the regulatory timelines.
Do you want to market Medical Devices in Switzerland?
Thema experts can provide you with the right support thanks to the Swiss Authorised Representative service.
As Swiss Authorised Representative (CH REP), Thema provides this service in full accordance with the Swiss regulation and ensures that all obligations conferred will be respected thanks to a dedicated insurance which guarantees the co-responsibility of defective products and thanks to an ISO 13485 certified business organisation.
Find out all the details of the service ➡️ https://bit.ly/3uV0Kur
For further information and costs, please contact us at the following address: email@example.com
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