The Authorized Representative is mandated by a written contract, registered in EUDAMED, and shares specific liabilities with the manufacturer. They hold technical documentation, interface with competent authorities, and handle vigilance reports. Non-EU manufacturers must designate an authorised representative under MDR and IVDR Article 11 through a written mandate. The representative must verify the declaration of conformity and technical documentation, keep documents available to authorities, cooperate on corrective actions and register in EUDAMED. They are jointly and severally liable with the manufacturer for defective devices, so they must also have their own PRRC.

Why it matters

Choosing a competent EC REP with strong notified-body and competent-authority relationships is a strategic - not just administrative - decision.

Common pitfalls

•Misunderstanding the Authorized Representative as a mere postal address, rather than a key regulatory actor with legally defined responsibilities.
•Failing to provide the Authorized Representative with full access to technical documentation, hindering their ability to perform required checks.
•Assuming the Authorized Representative bears sole liability, whereas liability is shared with the manufacturer for non-compliance.
•Not establishing a clear, written mandate with defined responsibilities, as required by EU MDR Article 11(3).

Sources

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Why compare MedTech terms side by side?

MedTech terminology is full of pairs that look interchangeable but carry very different regulatory, clinical, and commercial consequences. Picking the wrong framework, pathway, or standard early in a project can add months to a submission, invalidate clinical evidence, or trigger an audit finding. Side-by-side comparison is the fastest way to surface those differences before they become costly mistakes.

Each comparison on this page pulls from the same vendor-neutral, sourced definitions used throughout the MedTech Terms glossary. You see the one-line summary, the formal definition, why it matters in practice, common pitfalls, and the primary sources (FDA guidance, EU MDR/IVDR articles, ISO/IEC standards, MDCG documents, IMDRF principles) that back each entry. That makes the comparison defensible in regulatory strategy memos, design reviews, and submission narratives.

Common comparison patterns

Regulatory pathway choice - 510(k) vs PMA, 510(k) vs De Novo, Abbreviated vs Special 510(k).
Quality systems - QSR vs ISO 13485, QMSR vs QSR.
Software classification - SaMD vs SiMD, Locked vs adaptive AI.
EU frameworks - MDR vs IVDR, CE Mark vs UKCA.
Cybersecurity artifacts - SPDX vs CycloneDX SBOM, CVE vs CVSS.
Post-market actions - Recall vs field action, Removal vs correction.

How to use this tool

Pick term A and term B from the dropdowns, or click a preset above. The URL updates with both slugs so you can bookmark or share the exact comparison with a colleague, a notified body reviewer, or your regulatory consultant. Click Open full page on either side for the complete entry, including FAQs, related terms, and the full citation list. If you are not sure which term to start with, browse the Categories view or the A-Z index.

MedTech Terms is a vendor-neutral community resource sponsored by Blue Goat Cyber. Definitions are written for educational use and are not legal or regulatory advice.