EU Authorized Representative for Medical Devices

Your EU regulatory representative under MDR and IVDR. Based in Germany.

Manufacturers of medical devices and IVDs established outside the European Union must appoint a single EU Authorized Representative before placing their devices on the EU market, as required under Article 11 MDR and IVDR.
GSI CERT acts as your EU based regulatory contact and provides the representation, registration and authority communication required under the agreed mandate.
We offer a full mandate as your EU Authorized Representative: ● one point of contact● one contract● clear regulatory responsibility.
Establish your regulatory presence in the European Union with an experienced EU Authorized Representative based in Germany. We support non EU manufacturers with MDR and IVDR representation, registration and regulatory communication.

Your Regulatory Presence in the European Union

As your EU Authorized Representative, GSI CERT provides the regulatory interface between your company, European competent authorities and other relevant regulatory stakeholders within the scope of our mandate.
Our team of regulatory experts combines Authorized Representative services with practical MDR and IVDR market access expertise, allowing manufacturers to coordinate representation, registration and regulatory preparation through one experienced EU partner.

Scope of Services

Regulatory VerificationVerification of the EU Declaration of Conformity, technical documentation availability and applicable conformity assessment requirements.
EUDAMED Registration Support with economic operator and device registration obligations and verification of applicable manufacturer registrations.
Authority & Compliance CoordinationCommunication with competent authorities, regulatory document availability and cooperation regarding preventive or corrective actions.
Post Market Regulatory CoordinationForwarding complaints and incident information, cooperation with manufacturers and competent authorities, and support with regulatory communication relating to corrective actions and market surveillance.
Multilingual Support English, German, and additional languages – direct communication without translation loss.

Your Partner in Europe

MDR & IVDR ExpertiseRegulatory specialists experienced in medical device and IVD market access.
Based in GermanyDirect EU presence and communication with European authorities.
From Representation to Market AccessEU representation can be combined with MDR or IVDR readiness, technical documentation review and registration support.

Pricing Model

Our pricing is based on the regulatory scope, device portfolio, risk class and complexity.● One time onboarding and registration fee● Annual Authorized Representative fee● Portfolio based pricing for multiple devices

Request Your EU Representative Quote: