All terms
Common Specifications
Mandatory technical specifications under EU MDR/IVDR where harmonized standards are insufficient.
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed September 19, 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/IVDR requirements. The Commission adopts them where harmonised standards are missing or insufficient. Manufacturers who take another route must show an equivalent level of safety and performance. Examples include the common specifications for Annex XVI products without a medical purpose and for Class D IVDs. What the regulation says
The EU MDR (Regulation (EU) 2017/745) and EU 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
Common Specifications are adopted by the European Commission through implementing acts and compliance with them creates a presumption of conformity with the EU MDR/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.
Cross-references
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 (2)
Sources
3 sourcesSources support the definition or relevant regulatory context, not necessarily every claim on this page. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.
Tier 2Regulator guidance and consensus· 2Tier 4Trade press and expert commentary· 1
Link health: 3 verified· last checked 2026-06-20
European Commission·1IMDRF·1RAPS·1
- 1MDR/IVDR Common SpecificationsTier 2 VerifiedEuropean Commissionhealth.ec.europa.eu
- 2IMDRF DocumentsTier 2 VerifiedIMDRFimdrf.org
- 3RAPS Regulatory FocusTier 4 VerifiedRAPSraps.org
Inline markers like [1] jump to the matching reference above.