MedNet EC-REP GmbH

Booth number HALL 6A -A7-22

www.mednet-ecrep.com

MedNet EC-REP offers all the services needed to bring your medical devices, IVD & PPE to market approval throughout Europe: EC-REP (EU), UK RP (UK) & CH-REP (Swiss).

About us

With many years of experience and a highly qualified team, MedNet EC-REP offers you all the services needed to bring your products to market approval throughout Europe: the European Authorized Representative (EC-REP), the UK Responsible Person (UK RP) and the Swiss Authorized Representative (CH-REP).

We are specialised in medical devices, invitro diagnostics (IVD), personal protective equipment (PPE) as well as clinical investigations and performance studies. Additionally, we can apply for Free Sales Certificates (FSC).

Providing a single, personal contact assures you of a fast response time for registrations and short lines of communication for any kind of request. Over 700 customers worldwide are already making use of our service. Join them to enjoy this great service and become part of our community.

Address
MedNet EC-REP GmbH
Borkstr. 10
48163 Münster
Germany

Phone: +49 251 32266-64
Internet: www.mednet-ecrep.com

Products and Services

European Authorized Representative (EC-REP/EU-REP)
UK Responsible Person Service (UK RP)
Swiss Authorized Representative (CH-REP)
Free Sales Certificate (FSC)
EC-REP for Medical Devices
EC-REP for In Vitro Diagnostics (IVD)
EC-REP for Personal Protective Equipment (PPE)
Legal Representative for Performance Studies for In Vitro Diagnostics (IVD)
Legal Representative for Clinical Investigations for Medical Devices
UK RP for Medical Devices
UK RP for In Vitro Diagnostics (IVD)
CH-REP for Medical Devices
CH-REP for In Vitro Diagnostics (IVD)

European Authorized Representative (EC-REP/EU-REP)

Every manufacturer not established in Europe, but wishing to sell their products in the European Union, is required to appoint an authorized representative. Our experience from operating for more than 25 years assures you that we know all the registration requirements of each European country. Appointing an experienced and independent service provider instead of your local distributor as authorized representative avoids possible problems like exclusivity / limiting the open distribution.

Further reading

UK Responsible Person Service (UK RP)

Since January 1, 2021 any manufacturer based outside of the United Kingdom needs to appoint a UK Responsible Person (UK RP) when placing medical devices, in vitro diagnostics (IVDs) and cosmetics on the British market (England, Wales and Scotland).

A UK RP is required to register non-British manufacturers and their products BEFORE placing them on the British market.

Further reading

Swiss Authorized Representative (CH-REP)

Placing your medical device or in vitro diagnostics (IVDs) on the Swiss market requires the appointment of a Swiss Authorized Representative (CH-REP) in case you are not based in Switzerland

A CH-REP is required to register non-Swiss manufacturers with the Swiss competent authority Swissmedic.

Further reading

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