ESPR Conformity Assessment: Annex VI vs Annex VII and When a Notified Body Is Required

ESPR conformity assessment verifies that a product meets all applicable ecodesign performance requirements. ESPR provides two procedures: Annex VI (internal production control — no notified body required) and Annex VII (management system — may require a notified body). The applicable procedure is specified in the delegated act for your product category.

What Is ESPR Conformity Assessment?

Conformity assessment is the process by which manufacturers verify that their products meet all applicable ecodesign performance requirements before placing them on the EU market. ESPR Article 20 requires manufacturers to conduct a conformity assessment using one of the procedures set out in Annexes VI and VII. The applicable procedure is specified in the delegated act for the product category.

Truth Anchor: ESPR Article 20(1): "Manufacturers shall follow the conformity assessment procedure set out in Annex VI or Annex VII, as specified in the applicable delegated act, to demonstrate that the product complies with the applicable requirements." — EUR-Lex CELEX:32024R1781

Annex VI: Internal Production Control

Annex VI (internal production control) is the simpler of the two conformity assessment procedures. It allows manufacturers to self-certify compliance without third-party involvement. The manufacturer must: compile technical documentation demonstrating compliance; implement internal production controls to ensure that products placed on the market conform to the technical documentation; and issue the EU Declaration of Conformity.

Annex VI does not require a notified body. It is the expected default procedure for most product categories under ESPR. Manufacturers using Annex VI must be able to demonstrate compliance to market surveillance authorities on request.

Annex VII: Management System

Annex VII (management system) is the more rigorous conformity assessment procedure. It requires a documented quality management system covering product design, manufacturing, and testing. The management system must be approved by a notified body if the delegated act requires it. Annex VII provides higher assurance of compliance but is more burdensome than Annex VI.

Annex VII is expected to be required for high-risk products or products where the ecodesign performance requirements are difficult to verify through internal testing alone. The specific products for which Annex VII is required will be identified in the applicable delegated acts.

Comparison: Annex VI vs Annex VII

FeatureAnnex VI (Internal Production Control)Annex VII (Management System)
Notified body required No May be required
Quality management system Not required Required
Third-party audit Not required May be required
Internal testing Required Required
Technical documentation Required Required
EU Declaration of Conformity Required Required
Typical use Standard products; most ESPR product categories High-risk products; complex performance requirements

Notified Bodies Under ESPR

A notified body is a third-party conformity assessment organisation accredited by a EU Member State to assess compliance with EU regulations. Notified bodies are listed in the NANDO database (New Approach Notified and Designated Organisations) maintained by the European Commission. Under ESPR, notified bodies may be required for Annex VII conformity assessment where specified in the applicable delegated act.

When selecting a notified body, manufacturers should verify that the body is listed in the NANDO database for the specific product category and regulation. Not all notified bodies are accredited for all product categories or regulations.

The EU Declaration of Conformity

The EU Declaration of Conformity (DoC) is the formal output of the conformity assessment process. ESPR Article 22 specifies the required content of the DoC:

Required ElementDescriptionLegal Basis
Product identification Product name, model number, and any other identifiers ESPR Article 22(1)(a)
Manufacturer identity Name and address of manufacturer; name and address of EU Authorised Representative (if applicable) ESPR Article 22(1)(b)
Applicable delegated act Reference to the applicable delegated act and its publication date ESPR Article 22(1)(c)
Harmonised standards References to harmonised standards used to demonstrate compliance ESPR Article 22(1)(d)
Conformity assessment procedure Reference to the conformity assessment procedure used (Annex VI or VII) ESPR Article 22(1)(e)
Signature Signature of the authorised person; place and date of issue ESPR Article 22(1)(f)

Choosing the Right Conformity Assessment Procedure

ESPR provides two conformity assessment procedures: Annex VI (internal production control — self-declaration) and Annex VII (internal production control plus supervised product testing — third-party assessment). The delegated act for each product category specifies which procedure applies. Most product categories will use Annex VI. Annex VII is reserved for higher-risk products or products where self-declaration is considered insufficient.

The choice of conformity assessment procedure has significant practical implications. Annex VI can be completed entirely in-house — the manufacturer conducts the testing, compiles the documentation, and draws up the EU DoC without any external involvement. Annex VII requires engagement with a notified body — an independent third-party organisation designated by an EU member state to assess product conformity. Notified body assessments add cost (typically €5,000-€50,000 depending on product complexity) and time (4-12 weeks) to the compliance process.

Conformity Assessment Timeline

ActivityAnnex VIAnnex VII
Product testingIn-house or accredited lab: 2-8 weeksNotified body testing: 4-12 weeks
Technical documentationManufacturer: 2-4 weeksManufacturer: 2-4 weeks
Assessment decisionManufacturer: immediateNotified body: 2-4 weeks after testing
EU DoCManufacturer: 1-2 weeksManufacturer: 1-2 weeks after certificate
Total lead time6-14 weeks10-22 weeks

Harmonised Standards and Presumption of Conformity

ESPR Article 24 provides that products manufactured in conformity with harmonised standards (European standards published in the Official Journal of the EU as supporting ESPR) are presumed to conform with the ecodesign requirements covered by those standards. This "presumption of conformity" simplifies the conformity assessment process — manufacturers who apply harmonised standards do not need to conduct additional testing to demonstrate compliance with the requirements covered by those standards.

Harmonised standards for ESPR are developed by the European standardisation organisations (CEN, CENELEC, ETSI) at the request of the Commission. The list of harmonised standards for each product category is published in the Official Journal of the EU. Manufacturers should check the Official Journal for the latest list of harmonised standards for their product category before beginning the conformity assessment process.

Choosing the Right Conformity Assessment Module for ESPR

The choice of conformity assessment module for ESPR compliance depends on the requirements specified in the delegated act for your product category. Most consumer product categories will require Module A (Internal Production Control), which allows manufacturers to conduct the conformity assessment themselves without notified body involvement. Higher-risk product categories — particularly those with significant safety implications or where the ecodesign requirements are complex and difficult to verify — may require Module D1 (Quality Assurance of the Production Process) or Module H (Full Quality Assurance), which involve notified body oversight. Manufacturers should review the conformity assessment requirements in the delegated act for their product category carefully and engage with a notified body early if third-party involvement is required.

Notified Bodies for ESPR: How to Find and Engage One

Notified bodies for ESPR are designated by national authorities in EU member states and are listed in the NANDO (New Approach Notified and Designated Organisations) database maintained by the European Commission. To find a notified body for your product category, search the NANDO database for notified bodies designated for the relevant ESPR delegated act. When selecting a notified body, consider: their technical competence in your product category, their geographic location and language capabilities, their fee structure and turnaround time, and their reputation in the industry. Engage with the notified body early in the product development process — notified bodies are often fully booked several months in advance, and a last-minute engagement may not be possible before the compliance deadline.

Self-Declaration vs Third-Party Certification: Practical Implications

For products where Module A (self-declaration) is permitted, manufacturers must weigh the cost savings of self-declaration against the risk of non-compliance. Self-declaration requires the manufacturer to have the technical competence to conduct the conformity assessment — including the ability to perform the required tests (energy efficiency measurements, material composition analysis, carbon footprint calculations) and to interpret the results against the ESPR requirements. Manufacturers that lack in-house technical competence should consider engaging a third-party testing laboratory to conduct the required tests, even if the conformity assessment procedure does not legally require notified body involvement. Test reports from accredited laboratories provide stronger evidence of compliance than in-house test reports if a market surveillance authority challenges the manufacturer's conformity claim.

Conformity Assessment for Non-EU Manufacturers

Non-EU manufacturers placing products on the EU market must comply with the same conformity assessment requirements as EU manufacturers. The EU Authorised Representative can assist with the conformity assessment process, but the manufacturer remains responsible for ensuring that the product meets the applicable ESPR requirements. Non-EU manufacturers should engage with EU-based testing laboratories and notified bodies early in their ESPR compliance programme, as these organisations have experience with EU conformity assessment requirements and can provide guidance on the documentation needed to support the EU Declaration of Conformity. Non-EU manufacturers that export to multiple markets (EU, US, UK, Japan) should consider adopting a harmonised approach to conformity assessment that satisfies the requirements of all target markets simultaneously.

Conformity Assessment Timeline Planning

Manufacturers should plan their conformity assessment activities carefully to ensure that the CE marking can be affixed before the compliance deadline. The conformity assessment timeline depends on the module required by the delegated act. For Module A (self-declaration), the manufacturer can conduct the conformity assessment internally — the timeline is determined by the time needed to complete the required testing and prepare the technical documentation, typically 3–6 months for a straightforward product. For Module D1 or H (notified body involvement), the manufacturer must engage a notified body and allow time for the notified body's assessment — notified bodies are often fully booked several months in advance, and the assessment process itself may take 3–6 months. Manufacturers should begin their conformity assessment planning at least 12 months before the compliance deadline to allow sufficient time for testing, documentation, and notified body assessment if required.

Frequently Asked Questions: ESPR Conformity Assessment

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