Test engineeringMachine safety
Machinery Regulation 2027: what changes for manufacturers and operators
From 20 January 2027, the Machinery Regulation (EU) 2023/1230 applies and replaces the Machinery Directive 2006/42/EC. What counts is when a machine is placed on the market: existing machines do not have to be upgraded, but anyone who substantially modifies a machine becomes its manufacturer. The main new points are a narrower definition of substantial modification, protection against corruption and digital operating instructions.
From when does the Machinery Regulation apply and which law applies to which machine?
The Machinery Regulation applies directly in all EU member states from 20 January 2027; the Machinery Directive is repealed on the same day. Which law applies is decided by the date on which the individual unit is placed on the market or put into service, not by the order date.
The original version in the Official Journal still stated 14 January 2027. A corrigendum of 4 July 2023 changed the date to 20 January. Older articles therefore sometimes give the wrong date.
| Situation | What applies |
|---|---|
| Machine placed on the market by 19 January 2027 | Machinery Directive; the machine may continue to be made available (Art. 52) |
| Machine placed on the market from 20 January 2027, even if it was built in 2026 | Machinery Regulation with EU declaration of conformity under the new law |
| Existing machine substantially modified from 20 January 2027 | Machinery Regulation; whoever modifies it is deemed the manufacturer (Art. 18) |
| Existing machine without substantial modification | no new conformity assessment; operator duties under the German Industrial Safety Regulation (BetrSichV) |
| Partly completed machinery supplied from 20 January 2027 | Declaration of incorporation and assembly instructions under the new law |
In Germany, the MaschinenDG, the German act implementing the Machinery Regulation, supplements the regulation and replaces the 9th ProdSV, the previous German machinery ordinance. Operating instructions, safety information and declaration of conformity must be available in German, and administrative offences can be punished with fines of up to €100,000.
Retrofit under the Machinery Regulation: when do you become the manufacturer?
You become the manufacturer if you substantially modify a machine (Art. 18). Under Art. 3(16), a modification is substantial if it is a physical or digital modification not foreseen by the manufacturer that creates a new hazard or increases a risk and therefore requires additional guards or protective devices with an adaptation of the safety-related control system, or additional measures for stability or mechanical strength.
Checks for every modification
- What changes compared with the condition as delivered, in the mechanics, the electrics and the software?
- Does a new hazard arise or does an existing risk increase? If not, the modification is not substantial.
- Are the existing protective measures sufficient? If so, it is not substantial.
- Are additional protective devices needed whose integration changes the safety controller, or measures for stability or strength? If so, it is substantial.
- Document the result with reasons, even if it is “not substantial”.
| Modification (examples) | Usual assessment |
|---|---|
| PLC replacement with the same function and the same safety level | not substantial |
| Inverter replacement at the same speed and power | not substantial |
| Software update without effect on safety functions | not substantial, document the version nevertheless |
| Higher speed for which an additional light curtain is integrated into the safety controller | substantial |
| Higher load capacity for which the frame must be reinforced | substantial (strength) |
If, according to the risk assessment, the modification only affects one machine within an assembly of machinery, the manufacturer obligations apply only to that machine. Repair and maintenance without effect on safety are not a substantial modification. A control system migration with the same function and the same safety level is usually not one either.
If a service provider carries out the modification, they can become the manufacturer. We therefore specify in writing before the order who takes on the manufacturer obligations. There is no separate transitional rule for retrofit projects that run past the cut-off date. Clarify early on under which law the machine will go back into operation. To our knowledge, there is not yet a final version of an EU Commission guide to the Machinery Regulation; until then, the 2015 interpretation paper on substantial modification from the German Federal Ministry of Labour helps.
How does the risk assessment work and how do you determine the PLr?
The risk assessment remains the core: define the limits of the machine, identify hazards, estimate and evaluate risks, eliminate hazards or reduce risks (Annex III, General principles). For each safety function that reduces a risk, you derive from this the required Performance Level PLr to EN ISO 13849-1, usually via the risk graph.
The regulation now explicitly requires the assessment to also cover hazards from the self-evolving behaviour of machines with autonomous operation and from interactions within an assembly of machinery. The order of priority remains: first eliminate hazards, then protective measures, finally information on residual risks (Annex III, 1.1.2).
Risk graph: S, F and P give the PLr
- S, severity: S1 slight, normally reversible injury; S2 serious, normally irreversible injury or death.
- F, frequency and duration of exposure to the hazard: F1 seldom to less often or short; F2 frequent to continuous or long.
- P, possibility of avoiding the hazard or limiting the harm: P1 possible under specific conditions; P2 scarcely possible.
| S | F | P | PLr |
|---|---|---|---|
| S1 | F1 | P1 | a |
| S1 | F1 | P2 | b |
| S1 | F2 | P1 | b |
| S1 | F2 | P2 | c |
| S2 | F1 | P1 | c |
| S2 | F1 | P2 | d |
| S2 | F2 | P1 | d |
| S2 | F2 | P2 | e |
Example: A setter enters a robot cell once per shift for a few minutes (F1). A collision with the robot can cause serious injury (S2), and with fast movement they can scarcely get out of the way (P2). The risk graph gives PL d for the guard door monitoring.
Since the 2023 edition, Annex A helps with five criteria for choosing P: speed at which the hazard occurs, physical possibility of getting out of the way, recognisability of the hazard, qualification of the persons and complexity of operation. If the probability of occurrence of the hazardous event is low, the PLr may be lowered by one level; the justification belongs in the documentation. If a product standard, known as a C standard, specifies the PLr, that value applies.
How do you verify that a safety function achieves the PLr?
The Performance Level achieved results from the category (architecture), the MTTFD of the components, the diagnostic coverage DC, measures against common cause failures (CCF) and the average frequency of a dangerous failure per hour (PFH). It must be at least as high as the PLr. The calculation is usually done with the IFA software SISTEMA.
| PL | PFH per hour (EN ISO 13849-1) |
|---|---|
| a | 10−5 to less than 10−4 |
| b | 3 × 10−6 to less than 10−5 |
| c | 10−6 to less than 3 × 10−6 |
| d | 10−7 to less than 10−6 |
| e | 10−8 to less than 10−7 |
In the 2023 edition, the parameter is called PFH instead of PFHD; technically nothing changes. If a safety function consists of subsystems with known values, the PFH values are added:
PFHSF = PFHsensor + PFHlogic + PFHactuator
- PFHSF
- average frequency of a dangerous failure of the entire safety function in 1/h
- PFHsensor
- value of the input subsystem, for example light curtain or door switch, in 1/h
- PFHlogic
- value of the safety controller, for example F-CPU, in 1/h
- PFHactuator
- value of the output subsystem, for example two contactors with feedback, in 1/h
Example: Light curtain 1.5 × 10−8, F-CPU 2 × 10−9 and contactor combination 2 × 10−8 per hour give 3.7 × 10−8 per hour. This lies in the range of PL e, provided category, DC and CCF also meet the requirements. The values are examples; the data sheets are decisive.
For components subject to wear, such as contactors, valves and position switches, manufacturers state a B10D value instead of an MTTFD: the number of operating cycles until 10 % of the components have failed dangerously. From this, you convert using the usage:
nop = dop · hop · 3,600tcycle MTTFD = B10D0.1 · nop T10D = B10Dnop
- nop
- operating cycles per year
- dop
- operating days per year
- hop
- operating hours per day
- tcycle
- average time between two operating cycles in s
- B10D
- operating cycles until dangerous failure of 10 % of the components, according to the data sheet
- MTTFD
- mean time to dangerous failure in years
- T10D
- time in years after which the component must be replaced
Example: A contactor with an assumed B10D of 1,000,000 switches once per minute on 220 days for 16 hours each. That is 211,200 operating cycles per year, an MTTFD of around 47 years (high range, 30 to 100 years) and a T10D of around 4.7 years. The contactor must be replaced after 4.7 years at the latest, otherwise the verification no longer applies.
If the manufacturer only states a B10 value, the 2023 edition converts it using the ratio of dangerous failures RDF: B10D = B10 / RDF. Previously, without this information, 50 % was assumed, i.e. twice the B10. In addition to the analysis, the standard requires at least one functional test of each safety function; since 2023, validation has been covered in section 10 of Part 1.
What does the Machinery Regulation require on cybersecurity and controls?
A new point is protection against corruption in Annex III, 1.1.9: neither a connected device nor remote access may lead to a hazardous situation; safety-relevant software and data must be protected and interventions must be traceable. Section 1.2.1 requires controls to also withstand reasonably foreseeable malicious attempts by third parties.
- 1.1.9: Hardware that transmits safety-relevant signals or data must be protected against corruption. The installed safety-relevant software must be easy to display at any time. The machine must record legitimate and illegitimate interventions in software and configuration.
- 1.2.1: Faults in hardware, software and logic must not lead to hazardous situations. The manufacturer defines the limits of the safety functions in the risk assessment, and a learning phase must not change them in a hazardous way either. Logs of interventions and of versions of the safety software uploaded after placing on the market must be available to the authorities for five years.
- Autonomous, self-learning machines: they must not act beyond the defined task and movement space. Decision data of safety-relevant systems must be recorded for one year.
What does this mean at the machine?
- Remote maintenance only via a defined access point with approval by the operator.
- User rights and passwords on controller and panel, CPU access protection switched on.
- Version control: Which safety software with which signature is installed, who changed what and when?
- Network separation between office IT and machine network, only the necessary connections open.
- Updates with a check of whether they affect safety functions, and with documentation.
The IEC 62443 series of standards and the specification IEC/TS 63074 are often used for implementation. For products with digital elements, the Cyber Resilience Act (EU) 2024/2847 also applies: reporting obligations for actively exploited vulnerabilities since 11 September 2026, the remaining obligations from 11 December 2027. For operators, the DGUV, the German Social Accident Insurance, refers to the German technical rule TRBS 1115 Part 1 on cybersecurity.
May the operating instructions be digital and what belongs in the technical documentation?
Yes. The operating instructions may be provided digitally if the machine or the accompanying documents state where they can be found. They must be printable and downloadable and remain online for at least ten years (Art. 10(7)). If the buyer requests paper at the time of purchase, the manufacturer supplies it free of charge within one month.
- Non-professional users: for machines that private individuals can also use, the essential safety information must be supplied on paper.
- Declaration of conformity: may be provided via a web address or machine-readable code and must then be accessible for at least ten years (Art. 10(8)).
- Technical documentation: keep for at least ten years. On a reasoned request from the authority, this includes the source code or programming logic of the safety-relevant software (Art. 10(3)).
- Language: in Germany, operating instructions, safety information and declaration of conformity must be available in German.
What belongs in the documentation after a modification?
Risk assessment, drawings, applied standards, test reports and operating instructions for the modified state (Annex IV). For the safety controller, we also recommend the program version with signature, validation report and measured overrun times. After a change, instructions and documentation are brought up to date.
When do you need a notified body?
Only for machinery and products in Annex I. For the six categories in Part A, a notified body is always involved; for the 19 categories in Part B, it is not involved only if harmonised standards or common specifications cover all relevant requirements. The manufacturer assesses all other machines themselves (module A, internal production control).
| Group | Examples | Procedure under Art. 25 |
|---|---|---|
| Annex I Part A | Safety components with self-evolving behaviour using machine learning, machines with such embedded systems for safety functions, removable mechanical transmission devices, vehicle lifts | EU type-examination (module B) with module C, full quality assurance (module H) or unit verification (module G) |
| Annex I Part B | manually loaded presses for cold working of metal, manually loaded plastics and rubber injection moulding machines, protective devices designed to detect the presence of persons, logic units for safety functions, machinery for lifting persons | Module A only with fully applied harmonised standards, otherwise B with C, H or G |
| not in Annex I | most machines, such as assembly, conveying and test installations | Module A by the manufacturer |
This is where the practical problem lies: as of 8 November 2026, no list of harmonised standards for the Machinery Regulation has been published in the Official Journal. The Commission expects the first list before the end of 2026. It is to take over most of the standards listed so far, partly with restrictions where new requirements such as protection against corruption are not covered. If you are planning machines from Part B, you should talk to a notified body early on.
What do operators have to do by 2027?
The Machinery Regulation does not require existing machines to be upgraded. However, operators remain responsible under the German Occupational Safety and Health Act and the German Industrial Safety Regulation (BetrSichV): workplace risk assessment, inspections and state of the art. Action is needed above all for new purchases, modifications and networked machines.
- Check orders: for machines delivered from 20 January 2027, require conformity with the Machinery Regulation in the requirements specification and in the order.
- List modifications: Which projects go back into operation after the cut-off date? Assess each one: substantial or not, with documentation.
- Clarify the manufacturer role: for modifications by service providers, specify in writing in advance who takes on the manufacturer obligations.
- Check declarations of incorporation: declarations under the old law do not cover the new requirements for protection against corruption.
- Record remote access: Which machines are connected to the network, who has access, how is it approved?
- Update the workplace risk assessment: after every change, including those below the level of substantial modification.
- Inspection after a change: after changes subject to inspection, the work equipment must be inspected by a person qualified to carry out inspections before it is next used (§ 14(3) BetrSichV).
We prepare the workplace risk assessment under the German Industrial Safety Regulation for operators so that you can update it and present it during inspections.
How do we support you with CE marking, risk assessment and retrofit?
We assess your modification before it is carried out and give written reasons as to whether it is a substantial modification. If it is substantial, we prepare the risk assessment, technical documentation and operating instructions for the new state. The manufacturer issues the declaration of conformity.
| Service | What you get |
|---|---|
| Assessment of the modification | written justification before the modification, see CE marking |
| Risk assessment | to DIN EN ISO 12100 with protective measures and residual risks, see risk assessment |
| Safety technology | design to DIN EN ISO 13849 and validation of the safety functions |
| Modification | controls, drives, operation and safety technology in a retrofit, in our workshop in Wörth an der Donau or at your site |
What determines the effort?
Effort and duration depend on what you change, which documents are available and whether your machine falls under Annex I. Added to this are the system boundary, i.e. a single machine or a linked installation, the number of safety functions and whether an earlier risk assessment exists.
What we need from you for a quotation
- Machine type, manufacturer, year of construction and location, ideally as a photo of the rating plate
- Description of the planned modification and schedule
- Operating instructions, circuit diagrams, declaration of conformity and earlier risk assessment, where available
- How the machine is operated, set up and maintained
We record missing information on site.
Frequently asked questions about the Machinery Regulation
Answers to the questions machine builders and operators ask us about the 2027 cut-off date. As of November 2026, not legal advice.
Do existing machines have to be upgraded by 2027?
No. The Machinery Regulation applies to machines placed on the market or substantially modified from 20 January 2027. For existing machines, the workplace risk assessment and inspections under the German Industrial Safety Regulation (BetrSichV) continue to apply.
My machine is being built in 2026 but delivered in 2027. Which law applies?
What counts is the placing on the market of each individual unit. If the machine is placed on the market from 20 January 2027, it must comply with the Machinery Regulation, with a declaration of conformity under the new law.
Who is the manufacturer when a service provider carries out a retrofit?
Whoever carries out the substantial modification becomes the manufacturer (Art. 18). That can be your company or the service provider doing the modification. Record in writing before the order who takes on the manufacturer obligations. For our modifications, we agree this with you in advance.
Is a software update a substantial modification?
Only if it creates a new hazard or increases a risk and therefore requires additional protective devices with an adaptation of the safety controller. An update without effect on safety is not a substantial modification. However, versions of the safety software must be traceable.
Do I have to reassess an entire linked installation if I replace one machine?
Not necessarily. If the risk assessment shows that only one machine of the assembly is affected, the manufacturer obligations apply only to that machine. However, interfaces such as a shared emergency stop belong in the assessment.
May I supply the operating instructions in digital form only?
Yes, with a notice on the machine or in the accompanying documents, availability for at least ten years and paper within one month on request at the time of purchase. In Germany, they must be available in German.
Do EN ISO 13849-1 and EN ISO 12100 continue to apply after the cut-off date?
The standards remain the state of the art. However, the presumption of conformity depends on publication in the Official Journal, and as of November 2026 the list of standards for the Machinery Regulation is not yet available. For new designs, we recommend the 2023 edition of EN ISO 13849-1.
What does a CE assessment after a modification cost?
There is no flat rate. The effort depends on what you change, which documents are available, whether the machine falls under Annex I and how large the system boundary is. With the machine type, the planned change and the existing documents, we can estimate the scope.
Can you handle the risk assessment and the modification from a single source?
Yes. We prepare the risk assessment, implement the protective measures on the machine, validate the safety functions and update the documentation. The free Retrofit Check does not replace this assessment; it provides an initial technical assessment on site.
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Simon Niklas
Mechanical engineer, M.Sc.
+49 941 56956720[email protected]
“Good engineering proves itself in day-to-day production. That is why we combine technical planning with a close understanding of process, operation and maintenance.”
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