Sell your medical devices in Europe — with confidence and compliance.

If you’re a non-EU manufacturer, EU MDR 2017/745 and IVDR 2017/746 require you to appoint a legally established Authorized Representative (AR) in the European Union.

qointa provides full-scope AR services that ensure regulatory compliance, protect your market access, and safeguard your reputation.

What We Offer

As your EU AR, qointa will:

• Act as your official point of contact with EU Competent Authorities

• Register your device in EUDAMED

• Hold and maintain your technical documentation

• Monitor compliance with EU MDR / IVDR

• Support post-market surveillance and vigilance

• Represent your company in case of inspections or incidents