What is the consequence if a manufacturer does not follow a Common Specification?

If a manufacturer does not follow a relevant Common Specification, they must demonstrate that they have adopted solutions that ensure a level of safety and performance equivalent to that achieved by the Common Specification. This justification must be thoroughly documented and often requires review by a Notified Body during conformity assessment.

For which types of devices are Common Specifications primarily developed?

Common Specifications can be developed for various types of devices. 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.

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Common Specifications

Mandatory technical specifications under EU MDR/IVDR where harmonized standards are insufficient.

Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast 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/IVDR requirements.

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

Used by

Things that build on this term.

EU In Vitro Diagnostic Regulation(IVDR)

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A larger framework or document this term belongs to.

EU In Vitro Diagnostic Regulation(IVDR)

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.

Regulatory

EU Medical Device Regulation(MDR)

Regulation (EU) 2017/745 governing medical devices in the European Union.

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Primary references

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On this term

Category: Regulatory
Acronym: CS
Sources: 3
Updated: 5/5/2026

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Learn in 60 seconds

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.

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