EU IVDR Common Specifications: Implementing Regulation (EU) 2022/1107 for Class D

1. Key takeaways

Common Specifications (CS) are the second set of technical rules alongside harmonised standards. Article 9 allows the Commission to adopt CS where no harmonised standard exists, or where the existing harmonised standards are not sufficient to ensure the relevant general safety and performance requirements are met. The only IVD common specifications currently in force are Implementing Regulation (EU) 2022/1107, covering 13 annexes for Class D devices (one annex of common specifications applying to all devices plus 12 annexes for product categories), applicable from 2024-07-25; during the period from 2022-07-25 to 2024-07-25, products complying with the common technical specifications of Commission Decision 2002/364/EC were presumed to comply with the relevant requirements.

For Class D projects, the CS question is decided at the very beginning: the manufacturer checks the product against the twelve category annexes of (EU) 2022/1107 and either builds a conformity matrix against them or prepares a justification of alternative solutions that ensure at least an equivalent level of safety and performance. Because the EURL verification under Article 48(5) targets compliance with applicable common specifications, the CS file effectively becomes one of the reference documents for the entire Class D assessment.

2. Legal basis

The table below lists the primary legal sources on common specifications.

3. Expert insights

Insight 1: common specifications are a backstop, triggered by insufficient standards.

The structure of Article 9 is that, where no harmonised standards exist, where the relevant harmonised standards are insufficient, or where there is a need to address public health concerns, the Commission may adopt common specifications through implementing acts. This forms a two-tier system together with Article 8 on harmonised standards. In a compliance argument, the manufacturer first checks whether current harmonised standards listed in the Official Journal apply, then whether common specifications apply, and only where neither exists does the manufacturer build its own justification of equivalent solutions. Presenting the tiers in this order keeps the regulatory reasoning legible for notified body reviewers.

Insight 2: the twelve product categories of 2022/1107 are closely tied to transfusion and blood safety.

By structure, (EU) 2022/1107 contains one annex of common specifications applying to all devices and 12 annexes for product categories, covering detection or quantification of ABO, Rh, Kell, Duffy and Kidd blood group system antigens, and of HIV, HTLV, HCV, HBV, HDV, vCJD, CMV, EBV, Treponema pallidum, Trypanosoma cruzi and SARS-CoV-2 markers. These categories are simultaneously the Class D landing points under Rules 1 and 2 of Annex VIII. A blood safety or transplant screening portfolio therefore almost always intersects the CS, and the CS matrix should be built into the technical documentation from the outset of the project.

Insight 3: where the CS is not followed, an equivalence justification is required, not an explanation.

Article 48(5) requires the EURL to verify compliance with the applicable common specifications, or with other solutions that the manufacturer chooses to ensure at least an equivalent level of safety and performance. The justification must present comparable performance data and reasons; a narrative statement does not suffice. This equivalence file is among the most frequently requested additional items in Class D projects, so preparing it as a quantified comparison, with test results aligned to the CS parameters, saves an entire review round.

Insight 4: the date of application of the CS is independent of the certificate application date.

(EU) 2022/1107 applies from 2024-07-25, which is an objective date: whenever a certificate is applied for, any product placed on the market after that date must be assessed against the CS. During the transitional period from 2022-07-25 to 2024-07-25, products complying with 2002/364/EC were presumed to comply, but that presumption lapsed when the date of application passed and can no longer be relied upon. Planning filings around the certificate calendar therefore never displaces the obligation to meet the CS.

4. Practical recommendations

The following actions anchor the CS work in the Class D project.

1. As the first step of a Class D project, check the category list of (EU) 2022/1107 and determine whether the product falls within its coverage.
2. For covered products, build a CS conformity matrix annex by annex, marking the evidence source for each requirement (validation reports, literature, EURL opinions).
3. Where the CS is not followed, prepare the justification of alternative solutions under Article 48(5) with data and conclusions that can be compared in quantified form.
4. Check whether (EU) 2022/1107 has amendment proposals or category extensions in the pipeline (the Commission has circulated drafts on hepatitis E, Toxoplasma gondii, Plasmodium and arboviruses, not yet adopted, pending verification).
5. Record the relationship between the CS and harmonised standards in the applicable standards section of the technical documentation, to keep the two tiers distinct.

5. Verification checklist

Confirm the following points on common specifications.

• □ Whether the product falls within one of the 12 categories covered by (EU) 2022/1107 has been confirmed
• □ A CS conformity matrix has been built and evidence locations are marked
• □ Where the CS is not followed, the justification of alternative solutions has been completed (Article 48(5))
• □ The compliance status after the date of application 2024-07-25 has been confirmed
• □ The transitional presumption (2002/364/EC) has been confirmed as no longer available
• □ The status of CS extension drafts has been entered in the regulatory tracking list (pending verification)

Regulatory information verified as of October 29, 2026.

GRZAN supports IVD manufacturers in the EU market with CE certification pathway and classification strategy under Regulation (EU) 2017/746. For Class D programmes we help you map common specification coverage under (EU) 2022/1107, build CS conformity matrices, prepare equivalence justifications and keep your CS tracking current. Contact us at info@grzanglobal.com to discuss your EU IVDR programme.