Technical or clinical requirements adopted by Commission implementing act that manufacturers must comply with unless a demonstrably equivalent alternative is used.

Definition

Article 9 of the IVDR empowers the Commission to adopt Common Specifications (CS) covering general safety and performance requirements, technical documentation, clinical evidence, post-market surveillance, or performance studies. Where CS exist, manufacturers must comply with them unless they can duly justify an alternative solution that ensures a level of safety and performance at least equivalent.

Why it matters

CS are especially important for Annex II (List A/B legacy) high-risk assays such as HIV, HCV, HBV, and blood-group typing. Implementing Regulation (EU) 2022/1107 established the first set of IVDR CS for Class D devices. CS carry legal force stronger than harmonised standards.

Common pitfalls

•Treating CS as optional guidance. They are binding secondary law.
•Missing the CS revision cadence and continuing to rely on withdrawn CTS from the old IVDD regime.

Sources

Regulation (EU) 2017/746, Article 9 · EUR-Lex
Implementing Regulation (EU) 2022/1107 · EUR-Lex
FDA - Medical Devices · FDA

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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.