Meanwhile, the CE directives do not only apply to the member states of the EU.

In Switzerland and Liechtenstein, Turkey, Norway, and Iceland, the requirements of Directive 2006/42/EC (Machinery Directive = MD) must also be met. Placement on the market and operation require compliance with the safety requirements of the relevant directives and harmonized standards in order to achieve CE conformity.

The Machinery Regulation (MVO)—more specifically, EU Regulation 2023/1230—replaces the old Machinery Directive (2006/42/EC). As an EU regulation, it is directly binding in all member states. As of January 20, 2027, compliance will be mandatory for manufacturers.

An overview of key changes and requirements under the MVO:

Cybersecurity: Machines must be designed so that their safety functions are not compromised by unauthorized interference or cyberattacks.

The Cyber Resilience Act (CRA) is fast approaching. With this regulation, the European legislature has created a new—and, moreover, quite complex—regulation that companies are required to comply with and implement by early 2027. Since the Cyber Resilience Regulation is part of the CE conformity process, it must be taken into account accordingly when preparing the required legal documentation. In other words:

Anyone who is unable to implement the CRA in accordance with the law may not issue a CE Declaration of Conformity and, therefore, may not place a machine on the market.

Artificial Intelligence: Guidelines for machines with evolving behavior (AI systems) have been incorporated to minimize interactions and risks.

Key changes: There are now clear criteria for determining when a subsequent modification to a machine is so substantial that it is considered a “new machine” and requires a new conformity assessment procedure.

Digital Documentation: In the future, the EU Declaration of Conformity may be provided in a purely digital format. For user manuals, tiered rules regarding the paper format apply depending on the target audience (B2B or end consumers).

Obligations for Economic Operators: Importers and distributors will be held more accountable for product safety.

CE marking for new machines, plants and own constructions

RL2006/42/EC plays the central role in the manufacture of machinery. Machines intended for use in your own company must also undergo CE conformity testing. In this way, operating companies become manufacturers and distributors.

To determine how the MRLs apply, the following questions must first be clarified:
Which EU directives apply?

• Machinery Directive 2006/42/EC
• Pressure Equipment Directive 2014/68/EU
• ATEX – Product Directive 2014/34/EU
• Electromagnetic compatibility 2014/30/EU
• Low Voltage Directive 2014/35/EU
• Outdoor Directive 2000/14/EC

Other directives, such as:
EU Directive on the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment (RoHS) 2011/65/EU

EU Directive laying down ecodesign requirements for energy-related products (Ecodesign) 2009/125/EC with its corresponding regulations, e.g. for ventilation systems, electric motors.

By starting with standards research and risk assessment as early as possible, already during planning and development, you reduce subsequent costs due to technical and legal risks.

Engineering services include:

• Preparation of the risk assessment according to EN ISO 12100
• Determination of the safety-relevant interactions between the functional units of the machine arrangement
• Communication and networking with relevant disciplines and, if required, with notified bodies
• Division of the units into individual machines and complex plants in compliance with the applicable directives
• Division of the machine arrangement into functional units
• Derivation of possible protective measures
• Support and execution of assessments for the validation of safety functions according to EN ISO 13849 or EN ISO 62061
• Accompaniment and support for the creation of technical documentation
• Consulting and support for conformity assessment
• Preparation of the declaration of conformity until it is ready for signature
• Consulting and support for final inspections up to CE marking

Special advantages of engineering services:

• You will receive expert reports and documentation that are internationally recognized by government agencies and insurance companies.
• In your project, you rely on more than 25 years of project experience and the latest know-how on all relevant challenges of CE marking.
• You recognize necessary changes in your product planning and development at an early stage and reduce follow-up costs.
• You increase legal certainty in the use and marketing of your products.

Services as a safety engineer specializing in plant and workplace safety and as a certified safety specialist

On your behalf, I will perform the following duties for you:

• § 3 BetrSichV: Risk assessment of work equipment
• § 7 GefStoffV: Risk assessment of hazardous substances
• Instruction of employees
• Additional obligations based on the ASiG, BetrSichV, etc.