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.

Call Us Today

+32 3766 0078

Get your free consultation

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

Large experience

A team of experienced experts offers high standard services

Proven trustworthiness

Liable partner: keeps your business secrets secret

Responsible​ team

Shouldering liability and responsibility of manufacturers

Fast service

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

Our services

Medical device registration
Registered address within the EU
Assess technical documentations and declaration of conformities
Keeping all technical documents at the disposal of authorities
Assist with complaint handling, vigilance reporting and field safety corrective actions
Act as primary contact point for authorities and distributors
Consulting on European medical device regulations
Monitoring changes to the EU regulations and keeping manufacturers updated

For easy access to the European Market

Call Us Today!