Bring your high Quality Products
to the European Market
European Authorized Representative (EAR) services for medical devices
Welcome to the European Market
MDR-Consult VOF is a Belgium based company specialized in European Authorized Representative (EAR) services. With its dynamic expert team in medical device regulatory affairs and quality assurance, MDR-Consult VOF provides top services in aiding non-EU manufacturers to bring their high quality products into the European market.
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Get in touch with our team of experienced experts and explore the opportunities for your products on the EU Market.
What and why is an EAR
An EAR is any natural or legal person established within the EU who has received and accepted a written mandate from a manufacturer located outside the EU, to act on the manufacturer’s behalf in relation to specified tasks with regard to the manufacturer’s obligations under the European Regulations.
According to Medical Device Directive 93/42/EEC and the MDR 2017/745, a manufacturer outside EU must designate an EAR to place medical devices in the EU market.
MDR-Consult is your favorite EAR
A team of experienced experts offers high standard services
Liable partner: keeps your business secrets secret
Shouldering liability and responsibility of manufacturers
Quick response time: within 24 hours
Top geographical location Belgium
At the heart of Europe: easy logistics, distributer, and regulatory access
Reduce your investment
Reduce investment for manufacturers in compliance issues with price competitive service