Which devices are most affected by IVDR Common Specifications today?

Implementing Regulation (EU) 2022/1107 established the first set of IVDR Common Specifications, focused on Class D devices such as HIV, HCV, HBV, and blood-group typing assays historically listed under the old IVDD Annex II. These high-risk, historically well-characterised analyte categories are where CS compliance is most consequential for certification.

What happens if a manufacturer wants to deviate from a Common Specification?

The manufacturer must document and justify why its alternative solution provides a level of safety and performance at least equivalent to the Common Specification, and the notified body will scrutinise that justification during technical documentation assessment. Simply asserting equivalence without supporting data is a frequent basis for notified body non-conformities.

Is it a mistake to keep relying on old IVDD-era technical requirements once CS are adopted?

Yes. A common pitfall is continuing to rely on withdrawn or superseded technical requirements from the IVDD regime after a Common Specification has been adopted for that device category, which no longer satisfies IVDR Article 9 compliance. Manufacturers should track the CS revision cadence and update their technical documentation accordingly.

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RegulatoryRegulated Pathways Clinical Evidence Global MarketsCS

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.

Examples

A manufacturer of a Class D IVD for infectious disease screening must adhere to the specific performance characteristics and validation methods outlined in a Common Specification, or provide documented evidence that their alternative approach achieves an equivalent or superior level of safety and performance.
For new IVDs that analyze genetic markers for specific conditions, a Common Specification might mandate particular data presentation formats and statistical methodologies for clinical evidence, ensuring comparability and reliability across different devices.
A MedTech company developing an IVD for blood group typing, which is a high-risk application, would need to ensure their device's post-market surveillance plan aligns with the detailed requirements set forth in an applicable Common Specification, unless a justified alternative is proven equally effective.

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.

Frequently asked questions

Common Specifications are binding. Article 9 states that where the Commission has adopted CS, manufacturers must comply with them unless they can duly justify an alternative solution that ensures a level of safety and performance at least equivalent, which puts CS on a stronger legal footing than harmonised standards.

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Harmonised Standards

European standards cited by reference in the Official Journal of the EU that give manufacturers a presumption of conformity with corresponding legal requirements.

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Every citation below opens the original document. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.

Tier 1Binding law and standards· 2Tier 2Regulator guidance and consensus· 1

Link health: 2 verified 1 unchecked· last checked 2026-06-20

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Category: Regulatory
Acronym: CS
Sources: 3
Updated: 7/25/2026

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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.

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