All terms
Common Specifications (IVDR)
Technical or clinical requirements adopted by Commission implementing act that manufacturers must comply with unless a demonstrably equivalent alternative is used.
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed July 25, 2026
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. What the regulation says
Article 9(3) states that manufacturers shall comply with CS unless they can duly justify that they have adopted solutions that ensure a level of safety and performance at least equivalent thereto.
What this means in practice
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- •Missing the CS revision cadence and continuing to rely on withdrawn CTS from the old IVDD regime.
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsMore in Regulatory
· Same categoryRegulatory
510(k) Premarket Notification(510(k))
FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.
Regulatory
510(k) Summary vs 510(k) Statement
Two alternative disclosure mechanisms in a 510(k) submission, a Summary is public on FDA's website; a Statement promises to share Safety & Effectiveness info on request.
Regulatory
513(g) Request for Information(513(g))
Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification.
Regulatory
Abbreviated 510(k)
510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards.
Cited by
Where this term appears across MedTech Terms.
Ecosystems (3)
Primary references
3 sourcesLink health: 2 verified 1 unchecked· last checked 2026-06-20
EUR-Lex·2FDA·1
- 1
Regulation (EU) 2017/746, Article 9VerifiedEUR-Lexeur-lex.europa.eu
- 2
Implementing Regulation (EU) 2022/1107UncheckedEUR-Lexeur-lex.europa.eu
- 3
FDA - Medical DevicesVerifiedFDAfda.gov
Inline markers like [1] jump to the matching reference above.