Authorized Representative Services
Expand Your Reach with Trusted Representation
Entering new markets demands regulatory expertise and a reliable in-country presence. At PCS, our seasoned professionals serve as your Authorized Representative, ensuring compliance with jurisdiction-specific regulatory frameworks while facilitating seamless communication with authorities. Our experts adeptly navigate regional requirements, manage regulatory submissions, authorized representative medical device , emergo authorized representative and maintain post-market obligations, allowing you to expand globally with confidence while remaining fully compliant with evolving regulations.
EU Authorised Representative (EU-AR) : Full Article 11 mandates under MDR/IVDR, operating from our Netherlands strategic hub.
UK Responsible Person (UKRP) : Formal MHRA liaison and registration management for the Great Britain market.
Swiss Representative (CH-REP) : Navigating MedDO and IvDO requirements to maintain Swiss market continuity.
Australian Sponsorship (TGA) : Comprehensive management of ARTG entries and TGA regulatory interactions.
US Agent Services : Facilitating formal FDA communications, registrations, and submission tracking.
Free Sale Certificate (FSC) Services : Execution of export certification to facilitate global trade expansion.
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Your Compliance Journey – Simplified!
Appointing an Authorised Representative is a critical step in accessing regulated global markets. At Pinnacle Compliance Solutions, we simplify this process through a structured, end-to-end compliance approach that ensures seamless regulatory alignment and efficient market access for medical device manufacturers.
We begin by understanding your product scope, target markets, and regulatory obligations, followed by tailored compliance strategies aligned with MDR, IVDR, and international requirements. With a strong focus on precision, responsiveness, and regulatory excellence, we minimize compliance risks and support a smooth path to approval and market entry.
Technical File Verification
We audit Annex II and III documentation to ensure MDR/IVDR compliance, technical accuracy, and regulatory readiness from day one.
Jurisdictional Registration
We manage EUDAMED, MHRA, and Swissmedic registrations while handling regulatory communications to support continuous market access.
Vigilance & Market Defense
We oversee PMS and FSCA activities, supporting audits and ensuring fast, compliant incident reporting.
Our Five Step Journey Process
Strategy & Scope
Define target markets (EU, UK, CH) and establish the correct regulatory pathway.
Technical Verification
Expert audit of Annex II/III Technical Files to ensure
audit-readiness.
Mandate Execution
Formalize the Article 11 mandate and assume legal liability as your Representative.
Actor Registration
Complete EUDAMED and MHRA registrations to secure your SRN and legal ID.
Declaration & Launch
Verify final DoC and UDI data for a compliant and secure product launch.
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