EU IVDR Class A Conformity Assessment: Self-Declaration and Sterile Device Pathways

1. Key takeaways

Class A non-sterile is the only route under the IVDR that requires no notified body involvement at all: after compiling the technical documentation in Annexes II and III, the manufacturer issues the EU declaration of conformity on its own responsibility and affixes the CE marking (Article 48(10)). For Class A sterile devices, the manufacturer must apply Annex IX or Annex XI, and the involvement of the notified body is limited to the aspects relating to establishing, securing and maintaining sterile conditions.

The distinction matters commercially. Self-declaration means faster market entry and no notified body fees, but it does not reduce the manufacturer’s regulatory obligations in any way: technical documentation, general safety and performance requirements, performance evaluation, quality management, UDI labelling and registration duties all still apply. Sterile Class A, by contrast, pulls in a notified body for a narrowly defined scope, and the drafting of that scope in the contract determines both the fees and the assessment burden. Classification itself must be argued: Annex VIII Rule 5 lists only three families of products that fall into Class A, and any device carrying a claim on a specific analyte usually moves into Class B under Rule 6. Getting the classification right, and recording the reasoning, is therefore the first and most consequential step for any Class A candidate.

2. Legal basis

The table below lists the primary legal sources governing the Class A pathway.

3. Expert insights

Insight 1: self-declaration does not mean fewer obligations.

Article 48(10) removes notified body involvement, not manufacturer duties. Class A non-sterile products must still fulfil the full compliance stack: technical documentation in Annexes II and III (Article 10(4)), conformity with the general safety and performance requirements (Article 5(2)), performance evaluation (Articles 5(3) and 56), a quality management system (Article 10(8)), UDI assignment and UDI database submission (Articles 24(3) and 25), device registration (Article 26), registration of economic operators (Article 28) and post-market surveillance (Articles 78–80). In addition, evidence must be retained for ten years under Article 10(7). Manufacturers migrating from legacy regimes sometimes treat Class A as a light-touch category and under-resource it; market surveillance authorities can then request the complete documentation, and an unprepared file becomes a commercial risk rather than a formality.

Insight 2: the scope of Class A is narrower than intuition suggests.

Annex VIII Rule 5 lists only three families: general laboratory products, accessories without critical characteristics, and buffer solutions, washing solutions, general culture media and histology stains that the manufacturer makes suitable for a specific examination; instruments specifically intended by the manufacturer to be used for in vitro diagnostic procedures; and specimen containers. Once a product carries a claim on a specific analyte, it typically falls into Class B under Rule 6. The borderline between general laboratory products and analyte-specific reagents is a recurring classification dispute, so a written Rule 5 justification for every Class A item is essential and should be part of the technical documentation.

Insight 3: the scope of notified body involvement for sterile Class A must be written precisely.

The second subparagraph of Article 48(10) limits involvement to the aspects relating to establishing, securing and maintaining sterile conditions. If the contract phrase is drafted too broadly, the company pays for assessments beyond sterility; if it is drafted too narrowly, the notified body may reject the application on the ground that the scope is unclear. The scope should be transcribed from the regulation, mapped against specific processes such as validation of the sterilisation process, and agreed in writing before the quotation is signed.

Insight 4: UDI carriers come latest for Class A, but latest is not never.

Article 113(3)(e) provides that Article 24(4) on UDI carriers on labels and packaging applies to Class A devices from 2027-05-26. Assignment of the Basic UDI-DI and UDI-DI and submission of UDI data to the UDI database under Article 24(3), by contrast, are already required before placing on the market. The two deadlines are frequently confused, and treating the 2027 date as a reason to postpone data submission is a compliance error. Plan the carrier implementation against 2027-05-26 and the data submission against the market-entry date.

4. Practical recommendations

The following actions keep the Class A route both fast and defensible.

1. Issue a Rule 5 justification for every Class A item, showing why the device does not fall under Rule 6 or any later rule, to avoid confusion with Class B.
2. Maintain complete technical documentation per Annexes II and III for self-declared products and retain the evidence for the ten-year period under Article 10(7).
3. For sterile Class A, define in the contract that the notified body assessment scope is limited to sterile conditions, and agree the certificate form and surveillance arrangements.
4. Assign the Basic UDI-DI and UDI-DI under Article 24(3) and schedule the UDI carrier go-live for 2027-05-26 in line with Article 113(3)(e).
5. Complete the Single Registration Number under Article 28 and device registration under Article 26 before placing the device on the market.

5. Verification checklist

Confirm the following points before relying on the Class A route.

• □ The Class A justification under Annex VIII Rule 5 has been completed
• □ The sterile or non-sterile status is documented and the route choice (self-declaration, Annex IX or Annex XI) is recorded
• □ Technical documentation per Annexes II and III has been compiled and kept up to date (Article 10(4))
• □ The EU declaration of conformity has been issued under Article 17 (non-sterile route)
• □ For sterile Class A, the notified body involvement limited to sterile conditions has been confirmed in writing
• □ The UDI carrier go-live has been scheduled (Class A 2027-05-26, Article 113(3)(e))

Regulatory information verified as of October 29, 2026.

GRZAN supports IVD manufacturers entering the EU market with CE certification pathway and classification strategy under Regulation (EU) 2017/746. For Class A portfolios we help you build Rule 5 justifications, structure Annex II and III technical documentation, negotiate the sterile scope with notified bodies and schedule UDI and registration deliverables. Contact us at info@grzanglobal.com to discuss your EU IVDR programme.