For some time, many manufacturers and machinery importers have worked with a simple model: if it’s on Annex IV of the Machinery Directive, it’s high risk, and therefore you may need to consult a Notified Body.
This model remains helpful, however it’s about to change in a practical and compliance critical way. The new Machinery Regulation replaces the directive that this applies as of the 20th of January 2027, and it will reorganise the old Annex IV concept into a new structure. This will be Annex I, and it will be split into part A and Part B, with clearer rules about when notified body involvement is mandatory.
This blog will explain what this change means in practical terms, why people get confused about Notified Bodies, and how you can plan for conformity now.
The old world: Annex IV under the Machinery Directive
Under the Machinery Directive 2006/42/EC, high risk machinery is listed in Annex IV. The directive then links this Annex IV to specific conformity assessment procedures which are described in article 1(2).
Here’s the practical point that often leads to misunderstanding: Annex IV did not automatically mean that you had to use a Notified Body; it depended on whether you were able to rely on harmonised standards.
The Annex IV “gate”
If the machine is listed in Annex IV of the Machinery Directive and is manufactured in accordance with harmonised standards, and those standards cover all relevant essential health and safety requirements (EHSRs), then the manufacturer can use a permitted route that does not require Notified Body involvement. This is commonly described as the self-certification route.
If those conditions aren’t met, perhaps because standards don’t exist, or they don’t cover all relevant EHSRs, or you deviate from them, then you must use a conformity assessment route which involves a Notified Body, for example type examination or for full quality assurance.
So, the logic under the Machinery Directive was:
- Annex IV machinery with harmonised standards (which cover all relevant EHSRs) fully applied: a manufacturer self-assessment is possible, however;
- Annex IV machinery however only partial application of harmonised standards, or gaps or deviations in their application, or no full coverage by relevant EHSRs: a conformity assessment involving a Notified Body is required.
That nuance is exactly why 2 similar machines could end up with different conformity routes.
The new world: Annex I (Part A and Part B) under the Machinery Regulation
The new Machinery Regulation (EU) 2023/1230 maintains the idea of a special list of machinery or related products that require particular conformity assessment attention, however it restructures it.
Instead of Annex IV, you now look at Annex I, and crucially whether it appears in part A or part B.
What Part A versus Part B means
Annex I part A machinery and their related products (i.e. interchangeable equipment, safety components, lifting accessories, etc) in part A are subject to the specific conformity assessment procedures that are referenced in article 25 (2). In practice, these are the routes that required notified body involvement.
Annex I Part B broadly maintains the approach that is familiar from Annex IV, for example there is still scope to use an internal control route (self-certification) in certain cases; however with prescriptive conditions and escalation paths where reliance on common specifications or standards is no longer appropriate.
This is a crucial change: the regulation makes the “high risk” area more explicitly tiered rather than leaving it as a single list with a standards-coverage gate.
New machinery types
There are two factors that are important here:
- The list has been refreshed and reorganised: into Annex I part A or Part B rather than Annex IV; this change alone can move some products into a stricter or more clear notified body pathway.
- The regulation is designed to evolve: it includes mechanisms for the Commission to update the list of “high risk” machinery types over time to reflect both technological change and risk evidence. This is a particular reason why you may have seen commentary about new categories and future additions.
Practical differences between the Directive and Regulation
1. Timing and uniformity across the EU
A directive is implemented through national law regulation however is directly applicable. This is one reason the EU moved to a regulation- it aims for more uniform interpretation and enforcement across the member states
2. Conformity assessment; clear triggers for Notified Bodies
The Directives’ Annex IV logic hinges on “standards fully cover EHSRs”. The regulation introduces a more explicit structure: Annex I part A versus part B aligned to article 25 procedures.
3. Clearer rules for digital and software-based safety functions
The Machinery Directive covers software-based safety predominantly and implicitly through control system requirements, whereas the Machinery Regulation makes expectations around digital/safety-related software more explicit, including how safety functions are implemented and maintained and how information can be managed digitally.
4. An updated approach to information and documentation
The regulation is commonly summarised as being more “digital ready” in how particular instructions and documentation may be provided- subject to conditions. This can reduce administrative burden, but it increases the need for controlled document availability and version management.
Action Required
Here’s what you need to do now:
- First identify whether your products are currently within Annex IV of the directive and where they land within Annex I part A or B within the regulations.
- Map harmonised standards coverage against the machine’s applicable EHSRs as a whole assembly, however pay close attention to safety-related control functions and non-standard modes, as these are common areas where coverage is incomplete or assumptions regarding end use are made.
- Decide which route to conformity you will take early, particularly if the notified body capacity will become an operational bottleneck closer to 2027.
- Build evidence packs that are robust and will withstand scrutiny. These should include risk assessment, safety function validation, instructions and traceability.
Machinery Regulation Readiness with Knox Thomas
As with so many aspects of machinery safety compliance, it can be challenging and confusing to map out your machinery against the new Annex I part A or Part B structure, as well as choosing an appropriate conformity route, or simply tightening up your technical file or risk assessment evidence.
At Knox Thomas, we can help you interpret what’s changed and what it means for your specific equipment- and what you need to do next, in both practical terms, as well as pragmatically and proportionately.
