GSPRs replace the old Essential Requirements of MDD/IVDD. Manufacturers prepare a GSPR checklist mapping each requirement to the design output, harmonized standard, and documentary evidence demonstrating conformity. They sit in Annex I of the MDR and IVDR, in three chapters: general requirements, design and manufacture, and information supplied with the device. Requirements that do not apply must be justified in the checklist.

Why it matters

The GSPR checklist is the spine of the EU technical documentation and one of the first things a Notified Body audits.

Common pitfalls

•A common pitfall is failing to provide specific, traceable evidence for each GSPR, relying instead on general statements of compliance.
•Manufacturers often struggle to adequately address cybersecurity and data protection GSPRs, which require specialized expertise and detailed documentation.
•Another mistake is treating the GSPR checklist as a one-time activity rather than a living document that is updated throughout the device's lifecycle.
•Failing to link GSPR compliance to risk management outputs can lead to gaps in addressing potential harms and vulnerabilities.
•Incorrectly interpreting the scope and intent of certain GSPRs can result in inadequate technical solutions and non-compliance discoveries during audits.

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.