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Medical Device Compliance

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    Medical Device Compliance

    EU Authorised Representative and regulatory coordination for medical device manufacturers. We coordinate — we don\u0027t certify.

    • EU Authorised Rep (MDR)

      EU 2017/745 representation.

    • IVDR Representation

      EU 2017/746 in vitro diagnostics.

    • Notified Body Coordination

      We coordinate, we do not certify.

    • UDI Registration

      Unique Device Identification support.

    • MHRA Registration

      UK market access coordination.

    • Vigilance Reporting

      Post-market surveillance support.

    What You Need

    Medical devices sold in the EU must comply with the Medical Devices Regulation (MDR, EU 2017/745) or the In Vitro Diagnostic Regulation (IVDR, EU 2017/746). Non-EU manufacturers must appoint an EU Authorised Representative. Most medical devices require conformity assessment by a Notified Body. For the UK market, MHRA registration is required.

    • EU Market Access
    • Surveillance Liaison
    • Labeling Review
    • Regulatory Support

    Important Clarification

    We provide EU Authorised Representative services and regulatory coordination for medical device manufacturers. We do NOT perform conformity assessment, we do NOT issue CE certificates, and we do NOT replace a Notified Body. We coordinate between you and the Notified Body, help prepare documentation, and serve as your EU legal presence.

    Medical device representation starts at €3,500/year due to regulatory complexity. Book a call for a custom quote based on your device classification.