Article 34 of Machinery Regulation 2023/1230: Notification Procedure for Bodies

Article 34 of Regulation (EU) 2023/1230 establishes that notifying authorities must notify the European Commission and the other Member States of each conformity assessment body that complies with Article 30, using the Commission's electronic notification tool. The body may only start acting as a notified body if no objections are raised within two weeks (where accreditation has been used) or two months (where no accreditation has been used). In practice, this means no notified body is operational immediately: there is a window of Union-wide scrutiny before its certificates become valid.

What is the Commission's electronic notification tool?

It is the centralised IT system — known in the product regulation ecosystem as NANDO (New Approach Notified and Designated Organisations) — that the Commission develops and manages so that all notifying authorities of the Member States can enter and update information on designated conformity assessment bodies. Article 34 requires that this notification be carried out specifically through that tool, not through informal communications, letters or bilateral emails between authorities.

This has an important practical consequence for machinery manufacturers and importers: the validity of a certificate issued by a notified body can be verified by consulting this public database. If a body does not appear correctly notified with the scope (modules, machinery categories) it claims, any certificate it issues for that scope lacks legal backing under the Regulation.

What specific information must the notification include?

Article 34 sets out three blocks of mandatory information: first, the conformity assessment activities the body is competent to carry out; second, the applicable conformity assessment module or modules (as defined in the Regulation's annex, corresponding to the different procedures possible depending on the type of machinery and its risk level); and third, the product or products — that is, the categories of machinery or safety components — for which designation is requested.

In addition, where the body relies on accreditation (as provided for in Article 30 in relation to the accreditation framework of Regulation (EC) 765/2008), the relevant certificate of accreditation issued by the national accreditation body must be attached. This certificate serves as documentary evidence that an independent third party has already verified the body's technical competence before the notifying authority submits it to the Commission.

Who can object, and within what timeframe?

Both the Commission and any of the other Member States may raise objections to the notification received. The deadline depends on whether the designation relies on accreditation: two weeks if there is a certificate of accreditation, or two months if the body is not accredited and its competence has been assessed by other means (for example, direct assessment by the notifying authority). This difference in deadlines reflects the fact that accreditation already provides a layer of independent verification, so the additional scrutiny by the Commission and Member States can be shorter.

Only once that period has elapsed without objections may the body begin to legally act as a notified body. This means that any EU-type examination certificate or any other conformity assessment activity carried out before the deadline expires has no legal value under the Machinery Regulation.

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Case study: Mecanitzats Vallès, S.L.

Mecanitzats Vallès, S.L., a manufacturer of CNC machining centres based in Sabadell, needed to certify a new line of machines with self-learning functions under Annex I of the Regulation, which required intervention by a notified body. Its quality department contacted a Spanish body that claimed to have the necessary scope, but on checking the Commission's notification tool they found that the designation for that specific module had only been notified 5 weeks earlier and relied on a recent accreditation certificate. Since the 2-week objection period had already elapsed without incident, the body was fully operational, and Mecanitzats Vallès was able to sign the assessment contract with the legal certainty that the future EU-type certificate would be valid — avoiding a possible 3-4 month delay in launching the line had it needed to turn to a body still going through the process.

What happens if the Commission or a Member State raises objections?

Although the text of Article 34 focuses on the procedure when there are no objections, its implicit logic — consistent with the rest of the Regulation's market surveillance system — is that, while an objection is pending, the body does not acquire the status of an operational notified body. This requires notifying authorities to keep the technical documentation supporting each designation up to date and complete, since any deficiency detected by another Member State or by the Commission may block or delay the body's activation.

Why does this matter to manufacturers that are not notified bodies?

For a machinery manufacturer that requires third-party intervention (for example, for Annex I machinery subject to conformity assessment procedures involving a notified body), verifying that the certification provider complies with Article 34 — that is, that its notification is final and has passed the relevant objection period — is an essential due-diligence step. A certificate issued by a body whose notification is still within the objection period, or which was never properly completed, may be considered invalid for the purposes of CE marking and the EU declaration of conformity.

Is the electronic notification tool public?

Article 34 states that the tool is developed and managed by the Commission for exchanges between notifying authorities, the Commission and the Member States; it does not specify that it is generally publicly accessible, although in practice under the EU's New Legislative Framework the NANDO database allows designated notified bodies to be looked up.

What is the difference between notification with accreditation and without accreditation?

The main difference is the objection period: 2 weeks when the body provides a valid certificate of accreditation, versus 2 months when there is no accreditation involved, since in the latter case the Commission and Member States need more time to assess the body's competence without the prior backing of a national accreditation body.

Can a body start certifying before the objection period expires?

No. Article 34 is explicit: the body may only carry out the activities of a notified body if no objections have been raised within the applicable period. Any earlier action would lack the legal backing conferred by notified body status under the Regulation.

What information must mandatorily appear in the notification?

It must include the conformity assessment activities the body will carry out, the applicable conformity assessment module or modules, the product or products affected and, where applicable, the relevant certificate of accreditation issued by the national accreditation body.

Who can object to the notification of a body?

Both the European Commission and any of the other Member States may raise objections during the established period, which constitutes a cross-country control mechanism to prevent deficient designations.

Is this article related to Article 30 of the Regulation?

Yes, directly. Article 34 makes express reference to bodies that meet the requirements of Article 30 (requirements relating to notified bodies), thereby establishing the formal notification procedure that follows verification that the body meets those requirements.