The new Machinery Regulation (MR) replaces the Machinery Directive (MD 2006/42/EC). Don't waste any time and familiarise yourself now with the innovations and changes that affect your product and your conformity assessment process.

This will also enable you to anticipate possible customer demands that require contractual fulfilment of the Machinery Directive now or in the near future.

The half-day online seminar provides you with a compact and well-founded introduction to the new Machinery Regulation.

Seminar programme

Important basic knowledge

• What impact the transition from Directive to Regulation will have on businesses
• Why was Directive 2006/42/EC amended?
• By when does which regulation have to be applied?
• Why there is no transitional period and how you can best prepare for the deadline
• Attention! Depending on the duration of projects, you may have to comply with the new Machinery Regulation well before the deadline

New and changed requirements for design, control system construction and documentation

• Many things remain the same! Which relevant requirements are new or changed
• Which - in particular - mechanical changes are relevant
• What needs to be considered for machines with self-changing behaviour
• What is changing with regard to the requirements for control systems and what role security now plays.
• Digital operating instructions: where the limits and stumbling blocks lie.
• What additional content is required in the operating instructions

Changed conformity assessment processes and definitions

• Minor changes in the scope - how to determine if your product is affected by a change
• Significant change: Now regulated at European level with the new Machinery Regulation!
• What is changing in the conformity assessment procedures
• When your product falls into the "high-risk machine" category and what this means for you.
• Instructions for use: Why the "Original" label is no longer required.Declaration of conformity: Why it is no longer necessary to name an "authorised representative for compiling technical files" and what else is changing.

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Als Hersteller von Geräten und Maschinen oder als Zulieferer in die entsprechende Industrie verschaffen Sie sich einen umfassenden Überblick  zu den Regelwerken und den umweltrelevanten Aspekten, die das  Inverkehrbringen des Produktes sowie dessen Herstellung betreffen.

Klar strukturiert, praxisnah und kompakt erfahren Sie die  wissenswerten Grundlagen und aktuellen Entwicklungen – speziell mit  Fokus auf die Anforderungen für den Geräte-, Anlagen- und Maschinenbau.

Folgende Regelwerke werden thematisiert:

• REACH Verordnung (EU) 1907/2006
• RoHS Richtlinie 2011/65/EU
• Abfallrahmenrichtlinie (WFD) 2008/98/EG
• POP-Verordnung (EU) 2019/1021
• WEEE-Richtlinie 2012/19/EU
• BattVO (EU) 2023/1542
• (Entwurf der) EU-Verpackungsverordnung - PPWR

Seminarprogramm

Die Herausforderungen in der Material Compliance

• Material Compliance ist Voraussetzung für den Marktzutritt – lassen Sie sich nicht aussperren!
• Warum es immer mehr Anforderungen gibt – und das weltweit
• Als produzierendes Unternehmen sind Sie Teil der Lieferkette – wann und wie müssen Auskünfte gegeben werden?
• Der größte Aufwand steckt oft in den Dokumentations- und Berichtspflichten
• Wie Sie herausfinden von welchen Regelwerken Sie betroffen sind

Anforderungen an verwendete Stoffe & Material: REACH, RoHS, SCIP und POP

• Warum eine Maschine in den Anwendungsbereich der RoHS fallen kann
• Wann gilt die Auskunftspflicht gegenüber Abnehmern gemäß REACH und was muss der Kunde wissen?
• Wann Sie als Hersteller die Pflicht haben Ihr Produkt in der SCIP-Datenbank zu notifizieren
• Wie sie die richtigen Datenquellen für Material Compliance erschließen
• Wie integriere ich das Thema Material Compliance und Aspekte der Nachhaltigkeit in meine Lieferkette?

Anforderung an Design: BattVO, PPWR und WEEE

• Kein Batteriehersteller und dennoch in der Pflicht?! – die neue BattVO und Material Compliance
• Das kommt auf Sie künftig zu in Sachen Produktverpackung
• Mehr als eine Registrierung „für die Tonne“ – die WEEE-Registrierungsnummer
• Wie Sie Einfluss auf die Höhe ihrer Entsorgungsgebühren nehmen können – schon in der Entwicklung
• Welche Umwelt-Kennzeichnungen müssen auf das Produkt und/oder die Verpackung?

Abgrenzung: Dieses Seminar umfasst kein Gefahrstoffmanagement, keine  Belange der Arbeitssicherheit oder Compliance Themen wie Korruption,  Steuer, Zoll oder UN Charta.

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The machinery directive requires according to annex I:

"The manufacturer of machinery ...must ensure that a risk assessment is carried out ... The machinery must then be designed and constructed taking into account the results of the risk assessment."

This legal requirement for the integration of safety in the design processes is one of the most important success factors for the development of sufficiently safe machines or plants!

In this one-day seminar, you will learn how to implement these requirements in the daily design processes as efficiently and pragmatically as possible.

Without legal details - pure practical relevance!

This seminar shapes the first day of our two-day practical seminar "Efficient CE marking and risk assessment of machines and plants". On the second day, you will gain valuable background knowledge and learn how to efficiently implement the other points of the conformity assessment procedure according to the Machinery Directive (beyond the risk assessment).

Seminar program

Introduction and Overview

• The important role of the designers in the CE processes.
• Introductory example: Why seemingly good solutions do not always meet the legal requirements.
• Legally required risk assessment: WHO has to do WHAT and WHEN?
• Cooperation between different departments: mechanical engineering, control engineering, technical documentation, etc.
• Safety arises (mostly) in a team: important interfaces to sub-suppliers and customers.
• What does "integration of safety" mean?
• Which standards support safe design? Do these have to be applied?
• Caution when delegating design work or risk assessments to third parties!
• Attention! The design must be based on the law, not (only) on customer requirements!

Systematic risk assessment according to EN ISO 12100

• Risk assessment according to EN ISO 12100 - How the legal requirements are met as efficiently as possible!
• What has to be considered in "reasonably foreseeable misuse" - and what not.
• Figure 1 from EN ISO 12100 as a perfect guide through risk assessment and risk reduction.
• Relationships between EN ISO 12100 and the control engineering standards EN ISO 13849-1 and EN ISO 13849-2.

Technical and design requirements

• Which technical requirements are required by law.
• Strategies for the "inherently safe design".
• Why non-separating protective devices (e.g. light curtains) are not always suitable for achieving the required risk reduction.
• Calculation example for electro-sensitive protective devices (ESPEs).
• What you should pay attention to when selecting protective devices (separating or non-separating).
• When protective devices have to be interlocked - when guard lockings are required.

With the help of several exercises and examples, you will learn the practical approach to pragmatically identifying relevant hazards in the design process, assessing the associated risks and selecting and documenting suitable (and economically justifiable) solutions for risk reduction.

You will find out why design engineers tend to exaggerate safety-related solutions and sometimes result in high costs for their company or customers. Less is often more - but only according to the legally permitted concept!

Specially suitable for

• Designers and planners
• Technical managers and design managers
• Project leaders and project managers
• Career starters in design departments

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We have been providing knowledge with seminars on the CE marking of machines since 1994.

The aim of this seminar is to give you and your employees a quick overview of, the requirements that directives, regulations and standards place on designers,

how standards can be used as valuable sources of knowledge and how you can meet the legal requirements as quickly, efficiently and unbureaucratically as possible.

Key success factors: Safe design + efficient CE processes

This legal requirement for the integration of safety in the design processes is one of the most important success factors for the development of sufficiently safe machines or plants!

Therefore, we focus the first day of this seminar to the practical implementation of the legal requirements in the daily design processes - without legal details! Pure practical relevance!

On the second day, you will learn everything you need to know to carry out the legally required conformity assessment procedure efficiently and pragmatically.

Seminar: CE Marking according to Machinery Directive

Seminar program

Day 1: Designing safe machinery - Risk assessment in practice

Introduction and Overview

• Introductory example: Why seemingly good solutions do not always meet the legal requirements.
• Legally required risk assessment: WHO has to do WHAT and WHEN?
• Cooperation between different departments: mechanical engineering, control engineering, technical documentation, etc.
• Safety arises (mostly) in a team: important interfaces to sub-suppliers and customers.
• What does "integration of safety" mean?
• Which standards support safe design? Do these have to be applied?
• Caution when delegating design work or risk assessments to third parties!
• Attention! The design must be based on the law, not (only) on customer requirements!

Systematic risk assessment according to EN ISO 12100

Risk assessment according to EN ISO 12100 - How the legal requirements are met as efficiently as possible!

What has to be considered in "reasonably foreseeable misuse" - and what not.

Figure 1 from EN ISO 12100 as a perfect guide through risk assessment and risk reduction.

Relationships between EN ISO 12100 and

• control systems (EN ISO 13849-1)
• cyber-security
• artificial intelligence

Technical and design requirements

• Which technical requirements are required by law.
• Strategies for the "inherently safe design".
• Why non-separating protective devices (e.g. light curtains) are not always suitable for achieving the required risk reduction.
• Calculation example for electro-sensitive protective devices (ESPEs).
• What you should pay attention to when selecting protective devices (separating or non-separating).
• When protective devices have to be interlocked - when guard lockings are required.

With the help of several exercises and examples, you will learn the practical approach to pragmatically identifying relevant hazards in the design process, assessing the associated risks and selecting and documenting suitable (and economically justifiable) solutions for risk  reduction.

You will find out why design engineers tend to exaggerate safety-related solutions and sometimes result in high costs for their company or customers. Less is often more - but only according to the legally permitted concept!

Day 2: Efficient CE marking according to the Machinery Directive and Machinery Regulation

Response to basic questions

• The two most important points for the efficient implementation of the requirements of the Machinery Directive and Machinery Regulation.
• What are the risks in the event of non-compliance with the Machinery Directive and Machinery Regulation?
• What causes high "CE costs" and how can these be reduced?
• Who signs the declaration of conformity? What are the requirements?
• Does it make sense to install someone "responsible" for the CE marking, e.g. a CE coordinator or CE manager?
• Why these people usually cannot take responsibility for all design details and why the designers remain responsible.
• In which cases the use of external service providers can be worthwhile, for which they can take responsibility and for what not.

Step by step to the CE marking - legally secure and systematic

• Efficient project start: Why it is important to define the "limits of the machine" as early as possible.
• Classification of the product according to the Machinery Directive and Machinery Regulation: machine, partly complete machine, interchangeable equipment, etc.
• When do several independent machines become "assemblies of machinery"?
• Which directives must be observed in addition to the Machinery Directive and Machinery Regulation?
• Harmonized standards: What does "presumption of conformity" mean?
• Short repetition: Risk assessments (details are explained on the first day of the seminar).
• Arrange technical file: Content, language requirements, significance in the event of complaints from authorities and courts.
• Why it is important to also observe the formal requirements (language, form, etc.) of the instructions manual and assembly instructions.

Cooperation between various specialist departments or sub-suppliers

• Inspection obligations when purchasing machines and components
• What sales brochures have to do with product liability.
• Can buyers trust CE?
• Modification of machines: In which cases are you dealing with an “important change / substantial modification” and what does that imply?
• What interfaces exist between the departments or companies involved in a project (especially in industrial plant construction)?

Discussions, exercises and examples enliven the course of the seminar.

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