Common Specifications are sets of technical and clinical requirements adopted by the European Commission via implementing acts. Compliance creates a presumption of conformity with the corresponding MDR/IVDR requirements. The Commission adopts them where harmonised standards are missing or insufficient. Manufacturers who take another route must show an equivalent level of safety and performance. Examples include the common specifications for Annex XVI products without a medical purpose and for Class D IVDs.

Why it matters

CS exist for Annex XVI products (non-medical aesthetic devices) and certain Class D IVDs, among others. Where a CS exists, manufacturers must comply or justify equivalent solutions.

Common pitfalls

•Manufacturers might mistakenly assume that Common Specifications are optional if they believe their alternative solution is superior, without adequately justifying the equivalence to a Notified Body.
•Failing to regularly monitor for new or updated Common Specifications can lead to non-compliance, as these are dynamic documents published by the European Commission.
•Confusing Common Specifications with harmonized standards, which have a different legal basis and development process, can lead to misinterpretations of compliance requirements.
•Not understanding the specific scope of a Common Specification can result in applying it incorrectly to a device or overlooking its applicability to certain Annex XVI products or Class D IVDs.

Sources

MDR/IVDR Common Specifications · European Commission
IMDRF Documents · IMDRF
RAPS Regulatory Focus · RAPS

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.