{ "@context": "https://schema.org", "@type": "BreadcrumbList", "itemListElement": [{ "@type": "ListItem", "position": 1, "name": "Industries", "item": "https://www.mednet-ecrep.com/industries" },{ "@type": "ListItem", "position": 2, "name": "In Vitro Diagnostics" }] }
We're hiring! Join our team today. Apply now.
China Flag

In Vitro Diagnostics

Before introducing in-vitro diagnostic products to the EU market, ensure they comply with EU regulations for 'in-vitro diagnostics.' Non-EU manufacturers must appoint an Authorized Representative under IVDR for market access and compliance. Engaging the services of a European Authorized Representative (EC REP) for EEA member states is a mandatory step in compliance with the European Medical Device Regulations, specifically the In Vitro Diagnostic Medical Device Regulation (IVDR (EU) 2017/746). This ensures alignment with key aspects of the CE marking criteria.

Article 11 - Authorised Representative

1. Where the manufacturer of a device is not established in a Member State, the device may only be placed on the Union market if the manufacturer designates a sole authorised representative.

2. The designation shall constitute the authorised representative’s mandate, it shall be valid only when accepted in writing by the authorised representative and shall be effective at least for all devices of the same generic device group.

3. The authorised representative shall perform the tasks specified in the mandate agreed between it and the manufacturer. The authorised representative shall provide a copy of the mandate to the competent authority, upon request.

The mandate shall require, and the manufacturer shall enable, the authorised representative to perform at least the following tasks in relation to the devices that it covers.

No items found.

Target Markets Your IVD Can Enter with MedNet EC-REP

In Europe, the regulation of in vitro diagnostics is divided into three key regions. Each of them defines the relevant regulations and processes for market access. Discover the specific regulations applicable to your target market and learn how MedNet can assist you in achieving quick and effortless market entry.

European Union

European Union

In Vitro Diagnostics in the European Union as well as in Northern Ireland are regulated by Regulation (EU) 2017/746 (IVDR). According to this, non-EU manufacturers must appoint a European Authorized Representative (EC-REP) to place IVD on the EU member states or on the Northern Ireland market. MedNet EC-REP, based in Germany, is your first point of contact with local authorities and handle your products registration in the relevant member state database.

Great Britain

Since Brexit, the British market (England, Scotland and Wales) is no longer part of the EU and is governed by the local legislation UK MDR 2002. non-British manufacturers are allowed to place their In Vitro Diagnostics (IVDs) on the British market, they need to appoint a UK Responsible Person (UK RP) as their local legal representative. MedNet as your UK Responsible Person is based in Great Britain and knows the local regulations and current transitional requirements in the UK. Furthermore we register your products in the British Medicines and Healthcare Regulatory Agency (MHRA) database.

Great Britain
Switzerland

Switzerland

As not being a EU member and due to the expired Mutual Recognition Agreement (MRA) between the EU and Switzerland, IVDs are regulated by local Swiss regulations. The IvDO requires non-Swiss manufacturers to appoint a Swiss Authorized Representative (CH-REP) to get access to the Swiss market and being able to register their IVD with the local authority Swissmedic. MedNet as your CH-REP guides you through the Swiss regulatory landscape.

Get in Touch

Our cross-cultural team of scientists and engineers is well equipped to understand your needs.
Let us know your requirements and we will be at your service.

Why Choose MedNet EC-REP as Your Partner?

Our Services as Your Authorized Representative

Headquartered in Germany, with locations in Great Britain and Switzerland, our professionals provideservices throughout Europe, acting as your EC-REP, UK RP and CH-REP. With over 25 years of experience and an interdisciplinary team, we provide expert supportwith a profound background of current regulations in each country you are targeting.

EC-REP Service

EC-REP Service

To place your Medical Devices, IVD or PPE on the European market, we act as your EC-REP. Our service: Quick and uncomplicated product registration in the relevant database(s) as well as legalizations of Free Sales Certificates for foreign markets.

Product Registration

Product Registration

We carry out fast and straightforward registrations in all EU member states, as well as in Great Britain and Switzerland.

Free Sales Certificate

Free Sales Certificate

We offer full service and a fast turn around for Free Sales Certificates. Including legalizations for almost every Country in the world if required.

Get in Touch

Place all your regulatory needs into our hand:

Our team of PhD biologists and Medical Engineers will take care of your concerns - with one single point of contact and no matter which country you want to distribute into next.