When a notified body is mandatory (and when you can still self-certify)
A notified body is mandatory in two cases under Regulation (EU) 2023/1230: when your machine is in Annex I Part A (always, under Article 25(2)), and when it is in Annex I Part B and harmonised standards do not fully cover the relevant risks (Article 25(3)). If your machine is in Part B and standards do cover all the risks, or it is not listed in Annex I at all, you can self-assess.
This is general information about Regulation (EU) 2023/1230, verified as at 12 July 2026, not legal advice. Confirm your route against Article 25 and Annex I of the Regulation.
The three outcomes
| Classification | Route | Notified body? |
|---|---|---|
| Not in Annex I | Internal production control (Module A) | No |
| Annex I Part B, standards fully cover | Self-assessment, Art. 25(3) | No, if coverage proven |
| Annex I Part B, standards do not fully cover | Type-examination / QA / unit verification, Art. 25(3) | Yes |
| Annex I Part A | Notified-body route, Art. 25(2) | Yes, always |
Machinery not in Annex I: self-assessment
For the large majority of machines, which are not listed in Annex I, you can self-assess using internal production control (Module A). You compile the technical file, carry out the conformity assessment, draw up and sign the EU declaration of conformity, affix the CE marking and provide the instructions. No notified body is needed. This preserves what most self-certifying manufacturers do today.
Annex I Part A: notified body, always
For the six Part A categories a notified body is always involved under Article 25(2), and you cannot self-declare, regardless of whether harmonised standards were applied. This is the sharpest change from the Directive, where an Annex IV manufacturer who fully applied harmonised standards could still use internal production control. Those six categories lose that option entirely. See the Annex I guide.
Annex I Part B: it depends on your standards
Part B is the case where the answer turns on one fact. Self-assessment is available only if you have applied harmonised standards, or common specifications, that cover all the relevant health and safety requirements of the machine (Article 25(3)). If any relevant risk is left uncovered, or you did not apply the standards, you must use a notified body route, for example EU type-examination (Module B followed by Module C), full quality assurance (Module H), or unit verification (Module G).
Because the list of harmonised standards giving presumption of conformity is published and updated by Commission implementing decisions, a standard being added or withdrawn can move a Part B machine between self-assessment and a notified body. The document that carries the whole route is the technical file that proves full coverage, so keep it current.
Practical timing
Notified bodies can already issue certificates against Regulation (EU) 2023/1230 during the transition, even while the Directive still applies until 20 January 2027. Because demand concentrates towards the date and capacity is finite, engaging a notified body early is the single most time-sensitive action for any Part A machine or any Part B machine without full standards coverage.
Get your route named
The report names the specific conformity route for your machine with its Article 25 reference and ties it to your category and your standards-coverage answer, with a dated action checklist.
Get my machinery report →Sources
- Regulation (EU) 2023/1230, Article 25 conformity-assessment routes and Annex I. EUR-Lex; EUR-Lex summary (checked 12 July 2026).
- Self versus notified-body routes and the Part A change (research draft): F2 Labs (checked 12 July 2026). Notified bodies can already certify during the transition: TUV Rheinland (checked 12 July 2026).