Article 110 of the IVDR, as amended by Regulation (EU) 2022/112 and 2024/1860, allows devices with valid IVDD certificates or self-declared devices already on the market before 26 May 2022 to remain available for defined periods (into 2027 for Class D, 2028 for Class C, 2029 for Class B and sterile Class A), subject to no significant change in design or intended purpose and compliance with IVDR post-market and vigilance requirements.

Why it matters

Legacy status is a bridge, not a permanent state. Even legacy devices must comply with IVDR post-market surveillance, vigilance, registration in EUDAMED, and economic-operator obligations from the transition dates.

Common pitfalls

•Treating legacy status as an exemption from post-market obligations. It is not.
•Making a design change during the transition that voids legacy status.

Sources

Regulation (EU) 2017/746, Article 110 (consolidated) · EUR-Lex
Regulation (EU) 2024/1860 · EUR-Lex
FDA - Medical Devices · FDA

Open full page

Select term B to compare.

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.