--- title: "CS, Common Specifications | MedTech Terms" description: "Mandatory technical specifications under EU MDR/IVDR where harmonized standards are insufficient. Plain-English Regulatory definition for MedTech teams, with ex" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/common-specifications#term", "name": "Common Specifications", "alternateName": "CS", "description": "Common Specifications are sets of technical and clinical requirements adopted by the European Commission via implementing acts. 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Notably, they exist for certain Annex XVI products, which are devices without a medical purpose, and specific Class D in vitro diagnostic medical devices, as outlined in the EU IVDR." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Regulatory](/terms?cat=Regulatory) 6. / 7. Common Specifications [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways)[Global Markets](/ecosystems/global-markets)CS # Common Specifications Mandatory technical specifications under EU MDR/IVDR where harmonized standards are insufficient. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition 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](/terms/mdr-reporting)/ [IVDR](/terms/ivdr) requirements. What the regulation says The EU [MDR](/terms/mdr-reporting) (Regulation (EU) 2017/745) and EU [IVDR](/terms/ivdr) (Regulation (EU) 2017/746) introduce Common Specifications (CS) as a mechanism for establishing uniform requirements across the European Union. These specifications are adopted by the European Commission through implementing acts and are intended to provide detailed technical or clinical requirements, particularly where harmonized standards do not exist or are insufficient. Compliance with Common Specifications generally confers a presumption of conformity with the relevant requirements of the MDR or IVDR. ## What this means in practice 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. ## Examples - A manufacturer of aesthetic lasers, which fall under EU MDR Annex XVI, must adhere to the specific Common Specifications published for these types of products to demonstrate compliance with the regulation. - For a high-risk in vitro diagnostic medical device classified as Class D, the manufacturer must ensure their device meets the relevant Common Specifications established to address specific performance and safety aspects of such IVDs. - A company developing a non-medical facial filler product, an Annex XVI device, must integrate the requirements stipulated in the applicable Common Specifications into their design and manufacturing processes. 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. ## Frequently asked questions How do Common Specifications differ from harmonized standards? Common Specifications are adopted by the European Commission through implementing acts and compliance with them creates a presumption of conformity with the EU [MDR](/terms/mdr-reporting)/ [IVDR](/terms/ivdr). Harmonized standards are developed by European standardization bodies (e.g., CEN, CENELEC) and are referenced in the Official Journal of the European Union, also granting a presumption of conformity. What is the consequence if a manufacturer does not follow a Common Specification? For which types of devices are Common Specifications primarily developed? ## Cross-references ### Used by Things that build on this term. - [ EU In Vitro Diagnostic Regulation(IVDR) ](/terms/ivdr) ### Part of A larger framework or document this term belongs to. - [ EU In Vitro Diagnostic Regulation(IVDR) ](/terms/ivdr) ## 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 EU Medical Device Regulation(MDR) Regulation (EU) 2017/745 governing medical devices in the European Union. ](/terms/mdr) ### 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 (2) - [Regulated Pathways](/ecosystems/regulated-pathways) - [Global Markets](/ecosystems/global-markets) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 European Commission· 1 IMDRF· 1 RAPS· 1 1. [1 MDR/IVDR Common Specifications Verified European Commission · health.ec.europa.eu ](https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en) 2. [2 IMDRF Documents Verified IMDRF · imdrf.org ](https://www.imdrf.org/documents) 3. [3 RAPS Regulatory Focus Verified RAPS · raps.org ](https://www.raps.org/news-and-articles/news-articles) 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 5/5/2026 [Compare with another term](/compare?a=common-specifications) Learn in 60 seconds Card Lesson Quiz Mandatory technical specifications under EU MDR/IVDR where harmonized standards are insufficient. - · 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. - · Compliance creates a presumption of conformity with the corresponding MDR/IVDR requirements. Remember this Watch out: 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. Related terms - [EU Medical Device Regulation(MDR) ](/terms/mdr) - [EU In Vitro Diagnostic Regulation(IVDR) ](/terms/ivdr) You may also need Auto-suggested from Regulatory and shared keywords. - [Common Specifications (IVDR)(CS) ](/terms/ivdr-common-specifications) - [CE Mark ](/terms/ce-mark) - [EU Reference Laboratory (EURL)(EURL) ](/terms/ivdr-eu-reference-laboratory) - [IVDR Conformity Assessment Routes ](/terms/ivdr-conformity-assessment-routes) - [General Safety and Performance Requirements(GSPRs) ](/terms/gspr) - [General Safety and Performance Requirements (IVDR)(GSPR) ](/terms/ivdr-gspr) [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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