When will the new Machinery Regulation come into force and what deadlines apply?
The Machinery Regulation was published in the Official Journal of the European Union on 29.06.2023 and thus comes into force after the transition period of 42 months (20.01.2027). Some of the provisions of the Machinery Directive 2006/42/EC will continue to apply until then. There is no transitional period in which you can choose the CE marking according to which you create the CE marking.
Which points of the Machinery Regulation have already entered into force?
The following articles of the Machinery Ordinance have already entered into force since 19 July 2023:
- Article 6.7 Categories of machinery and related products which are included in Annex I and are subject to the relevant conformity assessment procedures. This has no effect on the manufacturer, as the list is only extended. However, the list should be read regularly to stay up to date.
- Article 48 Comitology procedure (no effect on the manufacturer)
- Article 52 Transitional provisions (Member States shall not impede the provision on the market of products placed on the market before 20 January 2027 pursuant to Directive 2006/42/EC. For products for which a procedure pursuant to Article 11 of the Machinery Directive has been initiated, Chapter VI of the Regulation (Union Market Surveillance and Safeguard Procedures) shall apply from 20 July 2023. (EC type-examination certificates and approvals remain valid until their expiry.)
Which points of the Machinery Regulation come into force before 20.01.2027?
Effective January 20, 2024,
- Chapter V Notification of conformity assessment bodies (no effect on the manufacturer)
Effective July 20, 2024,
- Article 6 paragraphs 2 to 6 and 11 Categories of machinery and related products listed in Annex I and subject to the relevant conformity assessment procedures (Power to adopt delegated acts amending Annex I and requirements on the procedure for including machinery in Annex I.)
- Article 47 Exercise of the delegation of powers (conditions for the adoption of delegated acts)
- Article 53, paragraph 3 Evaluation and review (requirements for regular evaluation and review of the Regulation
Effective October 20, 2026,
- Article 50 paragraph Sanctions (Member States adopt rules on sanctions.)
Does the new machinery regulation have to be applied to existing machines?
This Regulation should apply to machine products that are placed on the Union market, either new machine products manufactured by a manufacturer established in the Union or new or used machine products imported from a third country.
It does not have to be applied to existing machines. Exceptions are the "high-risk machines" (see list), if the product falls under these, a corresponding conformity assessment procedure must be made up.
What innovations result from the Machinery Regulation?
The biggest changes are as follows:
- There are "high-risk machines"
- The topic of security we to the manufacturer’s obligation
- The topic of artificial intelligence will be treated anew
- Many documents can be digitized.
What are high-risk machines according to the Machinery Ordinance and what do you have to consider?
Certain listed product categories must receive a mandatory conformity assessment by a notified body. This applies to high-risk machines; they are listed in Annex I of the Machinery Regulation. One of the following procedures must be used:
- (a) EU type-examination procedures (Module B) in accordance with Annex VII and subsequently conformity with the type based on an internal production control (Module C) in accordance with Annex VIII
- (b) Compliance based on comprehensive quality assurance (Module H) in accordance with Annex IX.
The list of "high-risk machines" in Annex I may be adapted according to technical progress, knowledge and new scientific knowledge.
What impact does the change in high-risk machines have on manufacturers?
Manufacturers must check whether their machines are listed in the six machine categories of the high-risk machines and must make up tests by a notified body, even if the manufacturers have applied the relevant harmonised standards. Furthermore, manufacturers must expect that the list of "high-risk machines" will be dynamically adjusted in the future. A continuous monitoring of the list completes the list of product compliance. Manufacturers must regularly refer to Annex I of the new Machinery Regulation, as it may be amended. Having an up-to-date status is particularly important.
- The machine must be designed and constructed that the connection of another device to the product via any function of the connected device itself or via a remote device communicating with the machine product does not lead to a dangerous situation.
- A hardware component for the connection, which is essential for the conformity of the machine with the relevant health and safety requirements, must be designed in such a way that that it is adequately protected against unintentional or deliberate adulteration.
- The machine must collect evidence of legitimate or unlawful interference with the hardware component.
- Software and data which are of crucial importance for the conformity of the machine product with the relevant health and safety requirements must be identified as such and adequately protected against unintentional or deliberate falsification.
- The machine must identify the installed software required for safe operation and be able to provide this information in an easily accessible form at all times.
- The machine shall collect evidence of lawful or unlawful intervention in the software or modification of the software installed in the machine product or its configuration.
What will change with regard to AI as a result of the Machinery Regulation?
Annex III Basic safety and health requirements for the design and construction of machine products now also apply to artificial intelligence. In the risk assessment of changeable machines (self evolving), the risks arising from this autonomous behavior must be taken into account accordingly. Controls of machine products whose behavior or logic are completely or partially variable must be designed and constructed in such a way that:
- (a) they do not cause the machine product to perform actions that go beyond its specified task and range of motion
- (b) it is possible at any time to correct the machine product to maintain its inherent safety.
What impact does the change in security and AI have on manufacturers?
The additional coverage of artificial intelligence and security necessitates extended security and documentation requirements for machine manufacturers. The Risk Assessment, the manufacturers must include malicious actions of third parties and take measures that ensure the safety and reliability of controls. The risk assessment, which a manufacturer of machines with AI must perform, must include the essential safety and health requirements and take measures that ensure the safety and reliability of the machines.
Since the new Machinery Regulation will impose requirements on cybersecurity, a voluntary cybersecurity certification scheme can already be used for certain product groups. This can be found in the EU Cybersecurity Act (CSA).
Which documents may be digitised under the Machinery Ordinance?
Manufacturers are allowed to provide digital operating instructions for B2B machines. However, at the request of the customer, manufacturers must deliver a paper version within six months of purchase.
Machines intended for consumers (B2C products) still require a manual in paper form containing the safety-relevant information.
The way to a secure product under the new Machinery Regulation:
easyCE can advise and support you in all the following steps so that you can bring a safe product to market.
1. Does my product fall under the EU Machinery Regulation?
Article 1 of the Regulation regulates whether a product falls under the new EU Machinery Regulation.
2. Risk assessment and harmonised standards
If a product complies with a harmonised standard, it is considered to comply with the safety objectives set out in the CE Directive/Regulation, provided that the safety objectives are covered by the standard.
The manufacturer must apply the corresponding conformity assessment procedure in accordance with the Machinery Regulation.
If the product is not a high-risk machine" (see list), the manufacturer carries out a production control with risk assessment to maintain conformity.
However, if the product is a high-risk machine" (see list), the manufacturer must have a type examination (Annex VII) carried out by a notified body or a comprehensive quality assurance according to Annex IX. A notified body must be involved in comprehensive quality assurance.
3. Technical documentation
The risk assessment and all technical documentation listed in Annex IV of the new EU Machinery Regulation must be able to be submitted up to 10 years after the machine has been placed on the market.
In comparison to the currently valid EU Machinery Directive, the operating instructions may also be provided explicitly digitally, whereby a free printed version must be provided on request.
4. Declaration of conformity and CE marking
With the declaration of conformity, a manufacturer declares that a product meets the requirements of all applicable CE directives/regulations. The structure and type of declaration of conformity is specified in the Machinery Ordinance.
The CE marking must be clearly visible, durable and legible on the product.
