A Notified Body is an organization designated by an EU Member State competent authority (and listed in NANDO) to carry out conformity assessment tasks under Regulation (EU) 2017/745 (MDR) or 2017/746 (IVDR) before a device is placed on the EU market. Designation itself is governed by Implementing Regulation (EU) 2017/2185 and the joint assessment process.

Why it matters

Under MDR/IVDR, Notified Body involvement is required for all devices above Class I (non-sterile, non-measuring, non-reusable surgical) and above IVD Class A non-sterile. As of 2026 there are approximately 50 MDR-designated and 15 IVDR-designated Notified Bodies, versus 80+ under the prior directives, which has driven multi-year queue times. The Commission and MDCG have issued repeated guidance (MDCG 2022-4, MDCG 2022-14, MDCG 2023-3) to increase capacity. Notified Bodies audit the quality management system, review technical documentation, issue CE certificates (valid up to 5 years), and conduct annual surveillance audits including unannounced audits per Implementing Regulation (EU) 2013/920.

Common pitfalls

•Submitting incomplete technical documentation. Notified Bodies charge for each round of review and clock the review time against contractual SLAs.
•Assuming a legacy MDD/IVDD Notified Body will automatically be designated for MDR/IVDR. Designation is per-code and per-regulation.
•Not planning for unannounced audits at critical suppliers. Article 44 of MDR requires the manufacturer to ensure the Notified Body has access.
•Confusing Notified Body with Competent Authority. Notified Bodies do conformity assessment; Competent Authorities do market surveillance and vigilance oversight.

Sources

NANDO Notified Body database · European Commission
MDCG 2022-11 Notified Body transfer · MDCG
Regulation (EU) 2017/745 Chapter IV · EUR-Lex

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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.

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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.