When Is the Involvement of a Notified Body Mandatory for a Machine?
Everything You Need to Know About Compliance for Your High-Risk Machine
For most machines, CE marking is achieved through the conformity assessment procedure known as internal production control, as defined in Article 12 of the Machinery Directive 2006/42/EC.
Under this procedure, the manufacturer demonstrates that the machine complies with the Essential Health and Safety Requirements (EHSRs) by preparing the technical documentation and issuing the EC Declaration of Conformity, without the involvement of a Notified Body.
However, there are specific situations in which European legislation requires the involvement of a Notified Body—an independent third-party organization that verifies the conformity of the machine before it is placed on the market.
Understanding when this step is required is essential for designers, manufacturers, and machinery safety professionals in order to avoid delays in market access, legal penalties, and liability.
In this article, you will learn
- When it is mandatory to involve a Notified Body.
- Which machines may require third-party certification.
- The conformity assessment procedures provided for by the Machinery Directive.
- The main changes introduced by the Machinery Regulation (EU) 2023/1230.
What Is a Notified Body?
A Notified Body is an accredited certification body designated by a Member State and notified to the European Commission to perform conformity assessment activities under European product directives and regulations.
For the machinery sector, the current legal framework is the Machinery Directive 2006/42/EC, which will be replaced by the Machinery Regulation (EU) 2023/1230 starting on 20 January 2027.
| Self-certification | Notified Body |
|---|---|
| The manufacturer declares that the machine complies with the Essential Health and Safety Requirements. | Conformity is verified by an independent third-party organization authorized by the European Commission. |
| Standard procedure applicable to most machinery. | May result in the issuance of an EC Type-Examination Certificate or the assessment of a Full Quality Assurance System. |
The General Rule: When Is a Notified Body Really Required?
The general rule is straightforward: the involvement of a Notified Body is required only for specific categories of machinery considered high-risk, as listed in Annex IV of the Machinery Directive (Annex I of the new Machinery Regulation).
For all other machinery, manufacturers may normally follow the internal production control procedure by preparing the technical file, carrying out the risk assessment, and issuing the EU Declaration of Conformity.
Important
Even for machinery falling under Annex IV, the involvement of a Notified Body is not always mandatory. The applicable conformity assessment procedure depends on the machine’s level of compliance with the relevant harmonised standards.
Annex IV Machinery: When the Requirement May Apply
Annex IV of the Machinery Directive includes approximately 23 categories of machinery considered to present a higher level of risk. Some of the most common examples include:
- Circular and band saws for woodworking.
- Surface planers and thickness planers with manual loading.
- Cold metal-working presses.
- Plastic and rubber injection or compression moulding machines.
- Machinery for underground works.
- Lifting appliances for persons.
- Machinery for manufacturing pyrotechnic articles.
- Presence-detection safety components.
- Power-operated movable guards with a protective function.
Keep in Mind
Being listed in Annex IV does not automatically mean that a Notified Body must be involved. It is also necessary to verify whether the machine has been designed in full compliance with the applicable harmonised standards.
The Three Conformity Assessment Procedures for Annex IV Machinery
For machinery covered by Annex IV, the Machinery Directive provides three different conformity assessment procedures. The appropriate procedure depends on the level of compliance with harmonised standards and on the manufacturer’s quality system.
1. Machinery Fully Compliant with Harmonised Standards
If the machine has been designed and manufactured in full compliance with all applicable harmonised standards, the manufacturer may proceed through internal production control, without involving a Notified Body.
This option is permitted only where the harmonised standards fully cover all relevant Essential Health and Safety Requirements.
2. Machinery Not Complying (or Only Partially Complying) with Harmonised Standards
Where the machine has not been designed in accordance with harmonised standards, where those standards do not cover all applicable risks, or where no relevant harmonised standards exist, the manufacturer cannot rely solely on self-certification.
In this case, the involvement of a Notified Body becomes mandatory. The body performs an EC Type-Examination, verifying that the machine model complies with all applicable Essential Health and Safety Requirements laid down by European legislation.
3. Full Quality Assurance System
As an alternative to EC Type-Examination, the manufacturer may implement a Full Quality Assurance System, which is also subject to assessment by a Notified Body.
The Notified Body periodically evaluates the manufacturer’s design, production, final inspection, and testing processes to ensure that the production system consistently complies with the Machinery Directive requirements.
Which Conformity Assessment Procedure Applies?
| Situations | Applicable Procedure |
|---|---|
| Machine fully compliant with the applicable harmonised standards | Self-certification through Internal Production Control |
| Harmonised standards are not applicable, are incomplete, or have not been fully applied | EC Type-Examination by a Notified Body |
| Full Quality Assurance System | Assessment and periodic surveillance by a Notified Body |
Machinery Regulation (EU) 2023/1230: What’s Changing
From 20 January 2027, the Machinery Directive 2006/42/EC will be replaced by the Machinery Regulation (EU) 2023/1230. While the overall conformity assessment framework remains largely unchanged, the new Regulation introduces several important changes for manufacturers.
| Machinery Directive 2006/42/EC | Machinery Regulation (EU) 2023/1230 |
|---|---|
| Annex IV | Annex I – Part A and Part B |
| More limited list of high-risk machinery. | Expanded list of high-risk machinery and safety components. |
| No explicit reference to self-evolving Artificial Intelligence. | Introduction of self-evolving AI-based safety functions among the products requiring third-party conformity assessment. |
| Current risk classification criteria. | More stringent risk classification criteria. |
Plan Ahead
Companies designing machinery for the European market should already assess whether their products will fall within the new high-risk categories introduced by the Machinery Regulation. Carrying out this evaluation early helps avoid delays in the CE marking process and allows sufficient time to involve a Notified Body if required.
What Happens If You Fail to Involve a Notified Body When Required?
Placing machinery on the market without the mandatory involvement of a Notified Body may have significant legal and commercial consequences.
CE Marking
The CE marking and the EU Declaration of Conformity may be considered invalid.
Penalties
Manufacturers may be subject to administrative penalties and, where provided for under national legislation, criminal sanctions.
Market Withdrawal
Market surveillance authorities may prohibit the placing of the machinery on the market or require its withdrawal.
Liability
The manufacturer may be held liable for damages resulting from failure to comply with legal obligations.
How to Determine Whether Your Machine Requires a Notified Body
Determining which conformity assessment procedure applies is not always straightforward. Performing a preliminary assessment helps identify the correct path and avoid mistakes that could compromise the validity of the CE marking.
Practical Checklist
| 1 | Verify whether the machine falls within Annex IV of the Machinery Directive (or Annex I of Machinery Regulation (EU) 2023/1230). |
| 2 | If the machine is not classified as high-risk, proceed with the standard internal production control procedure and prepare the technical file. |
| 3 | If the machine falls under Annex IV, identify the harmonised standards applicable to that type of machinery. |
| 4 | Verify that the harmonised standards fully cover all relevant risks and have been correctly applied. |
| 5 | If harmonised standards do not exist, are incomplete, or have not been fully applied, it is necessary to undergo an EC Type-Examination carried out by a Notified Body, or implement a certified Full Quality Assurance System. |
Recommendation
The classification of the machine should be carried out during the earliest design stages. Identifying the appropriate conformity assessment procedure from the outset helps avoid design changes, delays in CE marking, and additional costs during the final stages of product development.
Conclusions
The involvement of a Notified Body is not the standard conformity assessment procedure for all machinery placed on the European market. However, it becomes mandatory in specific cases established by European legislation, primarily for high-risk machinery listed in Annex IV of the Machinery Directive and, from 20 January 2027, in Annex I of Machinery Regulation (EU) 2023/1230.
Whether a manufacturer can rely on self-certification depends on the correct application of the relevant harmonised standards. Where such standards are unavailable, do not fully address all applicable risks, or have not been fully applied, the involvement of a Notified Body becomes a mandatory step before the machinery can be legally placed on the market.
With the entry into force of the new Machinery Regulation, third-party conformity assessment will become even more significant, particularly for machinery incorporating self-evolving Artificial Intelligence safety functions and for the new categories of products classified as high-risk.
Does Your Machine Require a Notified Body?
Correctly identifying the applicable CE marking procedure is essential to avoid delays, non-compliance, and challenges from market surveillance authorities.
AP Engineering supports manufacturers, importers, and machinery builders in determining the appropriate conformity assessment procedure, assessing whether the involvement of a Notified Body is required, and guiding clients throughout the entire certification process.
Contact us today for a preliminary assessment of your machine and to identify the most appropriate CE marking procedure.
