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Training: Preparing the technical file for your machine - CE Marking: Advanced level

  • May 4, 6, 8, 11, 13, 15, 18 and 22, 2026 - From 09:00 to 13:00
  • Online sessions
  • Price for amec members: 1.395€+VAT. 10% discount before April 20th.

Why not miss it?

CE marking is not an administrative formality, it is a legal obligation linked to access to the European market and the direct responsibility of the manufacturer.

This training course covers in a structured manner the legal framework of the European Union, the obligations of economic operators and the practical application of the Directive 2006/42/EC together with the Royal Decree 1644/2008.

You will understand how to apply the essential health and safety requirements, how to intervene with a Notified Body when appropriate and how to correctly structure the Technical File.

In an increasingly demanding industrial environment in terms of regulatory compliance and civil and criminal liability, mastering these aspects makes the difference between operating with legal certainty or taking unnecessary risks.

Sign up for training: Prepare your machine's technical file - CE marking - advanced level!

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What benefits will you get?

  • Upon completion, you will have the ability to design and internally manage the CE Marking Technical File, correctly prepare the EU Declaration of Conformity, define the marking plate and structure the risk analysis according to the applicable requirements.
  • You will know how to identify which directives affect your products, how to apply harmonized standards and how to document tests, calculations and instruction manuals on a sound technical basis.
  • This translates into greater technical autonomy, reduced external costs, less exposure to sanctions and a direct improvement in the competitiveness and credibility of your company in international markets.

Course content:

We will incorporate the notions of the new Regulation (EU) 2024/2847 on Horizontal Cybersecurity Requirements which is already in force (Publication of the Official State Gazette OJEU No. 2847 of November 20, 2024) and will be applicable as of December 11, 2027 (although some of its articles will already be applicable between June and September 2026) and which, as far as the Machinery Directive and the New Regulation are concerned, will be applicable as of December 11, 2027 (although some of its articles will already be applicable between June and September 2026).

We will also incorporate the notions of the new Regulation (EU) 2024/1698 on Artificial Intelligence which is in force since June 13, 2024 (Publication of the Official State Gazette OJEU No. 1689 of July 12, 2024) and will be applicable from August 2, 2026 (although some of its articles will already be applicable from February 2025) as regards the Machinery Directive and the new Regulation in reference to the technical information documents (risk analysis, technical documents, instructions for use, etc.).

Module 1 (4 hours): TERMS AND CONCEPTS

  • CE Marking / EU DC / EU DI / CE Marking Plate / Technical Documentation / Certification / Notified Body
  • Basic Legal Concepts of the European Union. Directives, Regulations, Decisions, etc.
  • The economic agents. Manufacturers, Authorized Representatives, Importers and Distributors.
  • What does CE marking mean?
  • Products requiring CE marking: mandatory or voluntary?
  • What requirements must be met in order to have CE Marking? Directives and Harmonized Standards (Products Included or Not, Products affected by several Directives).
  • Evaluation Processes. Accreditation and Notified Bodies. Notification Authority
  • Responsibilities of CE Marking.

Module 2 (8 hours): CE MARKING DIRECTIVES – DM 2006/42/CE

  • Directive 2006/42/CE and Royal Decree 1644/2008
  • Definitions of interest.
  • Essential health and safety requirements. Complementary requirements. Risk assessment – Design of safety solutions in machinery.
  • The content of the Technical File.
  • Verification of essential health and safety requirements: Identify the annex of the DM to be applied / Intervention of Notified Body.
  • Hazard analysis, risk assessment and safety measures adopted.
  • Tests and calculations.
  • Documentation to be attached.
  • The instruction manual: contents with reference to risk assessment.

Module 3 (8 hours): CE MARKING TECHNICAL FILE

  • Types of technical file according to the product and its manufacture: machines/quasi-machines/production lines/machines.
  • Internal Manufacturing Control.
  • The total security method.
  • EXTEC maintenance
  • Efficient methodology so that the company itself can correctly prepare the technical file of a machine.
  • The EU Declaration of Conformity / EU Declaration of Incorporation.
  • CE marking plate: content with respect to the product.

Module 4 (12 hours): CE MARKING TECHNICAL DOSSIER PRACTICES

  • Practical examples of application.
  • Verification and comments on the technical files provided by the attendees.

THE DESIGN AND MANAGEMENT OF CE MARKING TECHNICAL DOSSIERS

  • Project implementation and management

Speaker

Alfonsa Ledesma

Alfonsa Ledesma

Managing Director of Advanced Consulting and Engineering Iberia (A.C.&E. Iberia) and Manualistics Techmance®. She started her career as a TC (Technical Communicator) in 1992 in Italy creating the DT (technical documentation) required by the CE marking directives. There he came into contact with the world of machine safety, which has been his other area of research ever since.

Technical data

The member companies of amec have a 40% discount on the price and a 20% discount for Ascamm and AER members.

Members of amec1395€ + 21% VAT

Ascamm and AER members: €1860 + 21% VAT

Non-member companies: 2325€ + 21% VAT

Minimum number of attendees: 7

Management of the Fundae Bonus:

amec can manage the Fundae bonus for associated companies participating in these workshops, for this we must have the necessary documentation 7 days before the start of the course.

For cancellations made 7 days prior to the start of the training, no refund will be possible.

Do you have any questions? send an email to Eva Pahissa – epahissa@amec.es – Telf.: 630366789

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