--- title: "CS, Common Specifications (IVDR) | MedTech Terms" description: "Technical or clinical requirements adopted by Commission implementing act that manufacturers must comply with unless a demonstrably equivalent alternative is…" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/ivdr-common-specifications#term", "name": "Common Specifications (IVDR)", "alternateName": "CS", "description": "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. 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[Home](/) 2. [Terms](/terms) 3. [Regulatory](/terms?cat=Regulatory) 4. Common Specifications (IVDR) [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways)[Clinical Evidence](/ecosystems/clinical-evidence)[Global Markets](/ecosystems/global-markets)CS # 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 Cyber](/authors/christian-espinosa) Last reviewed July 25, 2026 ## Definition Article 9 of the [IVDR](/terms/ivdr) empowers the Commission to adopt [Common Specifications](/terms/common-specifications) (CS) covering [general safety and performance requirements](/terms/gspr), technical documentation, clinical evidence, [post-market surveillance](/terms/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](/terms/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 theme ### Editor's picks · Hand-selected related concepts [ Regulatory EU In Vitro Diagnostic Regulation(IVDR) Regulation (EU) 2017/746 governing in vitro diagnostic medical devices in the EU. ](/terms/ivdr)[ Regulatory General Safety and Performance Requirements(GSPRs) Annex I requirements under EU MDR/IVDR that every device must demonstrate it meets. ](/terms/gspr) ### More in Regulatory · Same category [ Regulatory 510(k) Premarket Notification(510(k)) FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate. ](/terms/510k)[ 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. ](/terms/510k-summary-vs-statement)[ 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. ](/terms/513g)[ Regulatory Abbreviated 510(k) 510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards. ](/terms/abbreviated-510k) Cited by Where this term appears across MedTech Terms. Ecosystems (3) - [Regulated Pathways](/ecosystems/regulated-pathways) - [Clinical Evidence](/ecosystems/clinical-evidence) - [Global Markets](/ecosystems/global-markets) ## Primary references 3 sources Link health: 2 verified 1 unchecked · last checked 2026-06-20 EUR-Lex· 2 FDA· 1 1. [1 Regulation (EU) 2017/746, Article 9 Verified EUR-Lex eur-lex.europa.eu ](https://eur-lex.europa.eu/eli/reg/2017/746/oj) 2. [2 Implementing Regulation (EU) 2022/1107 Unchecked EUR-Lex eur-lex.europa.eu ](https://eur-lex.europa.eu/eli/reg_impl/2022/1107/oj) 3. [3 FDA - Medical Devices Verified FDA fda.gov ](https://www.fda.gov/medical-devices) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Navigating an FDA or EU MDR submission? Blue Goat Cyber supports the cybersecurity content of premarket submissions, from threat models to the 524B narrative. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Regulatory Acronym CS Sources 3 Updated 7/25/2026 [Compare with another term](/compare?a=ivdr-common-specifications) Learn in 60 seconds Card Lesson Quiz Technical or clinical requirements adopted by Commission implementing act that manufacturers must comply with unless a demonstrably equivalent alternative is used. - · 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. Remember this Watch out: Treating CS as optional guidance. They are binding secondary law. Related terms - [EU In Vitro Diagnostic Regulation(IVDR) ](/terms/ivdr) - [General Safety and Performance Requirements(GSPRs) ](/terms/gspr) You may also need Auto-suggested from Regulatory and shared keywords. - [Common Specifications(CS) ](/terms/common-specifications) - [Person Responsible for Regulatory Compliance(PRRC) ](/terms/prrc) - [Class D Batch Verification (IVDR) ](/terms/ivdr-class-d-batch-verification) - [General Safety and Performance Requirements (IVDR)(GSPR) ](/terms/ivdr-gspr) - [IVDR Performance Evaluation ](/terms/ivdr-performance-evaluation) - [Special Controls ](/terms/special-controls) [All Regulatory terms](/terms?cat=Regulatory) From the Blue Goat network Related resources and services on this topic. - [ MedTech Cybersecurity Standards Authoritative reference for the standards and guidances behind medical device cybersecurity. ](https://medtechcyberstandards.com) - [ MedTech Cybersecurity Crosswalk International crosswalk of medical device cybersecurity requirements across regulators. ](https://mdccrosswalk.com) - [ MedTech Truths Common misconceptions about medical device development - debunked. ](https://mdcmisconceptions.com) - [ MedTech Launchpad MedTech funding rounds, accelerators, and launch resources. ](https://medtechlaunchguide.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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