Technical legislation

Program

The Path to the CE Mark

Workshop and materials will be in English language.

Ensuring the conformity of technical products has never been an easy task – on the one hand there is the obligation that only compliant (and thus safe) products may be placed on the market or put into service, and on the other hand there is the awareness that compliance efforts must not go beyond competition. New needs or expectations of users, ever faster development cycles, the emergence of new technologies, the growth of online sales, challenges in supply chains, sales variations, instability of the production process, etc. pose even greater challenges and dilemmas for economic operators today.

At the workshop, we will use examples of good and bad practices to explain how to:

  • be guided by the extensive technical legislation of the European Union,
  • identify relevant technical regulations (directives, regulations),
  • avoid the pitfalls of obtaining authentic and relevant evidence of conformity when importing products from non-European countries,
  • provide or prepare technical documentation of compliance,
  • carry out testing and/or certification procedures,
  • correctly label technical products,
  • respond and take action in the event of market surveillance.

We will present Regulation (EU) 1020/2019/ on Market Surveillance, which defines the responsibilities and duties of online suppliers of goods and Regulation on Ecological Product Design (Eco-design) which enforces approximately 30 implementing regulations and requires IF labelling. We will explain the role of risk assessment as a tool for ensuring the conformity of technical products already in the planning phase and the possibilities for identification.

Day 1

  • The conditions for placing technical products on the market or putting them into service.
  • Differences in responsibilities between types of economic operators in the supply chain.
  • Market surveillance activities over technical products and possible control outcomes, implementation of corrective measures and guidelines for dealing with recall.
  • The dimensions of the CE marking, the New Approach directives, and the legislative framework for product marketing (NLF).
  • Recent changes and innovations in technical legislation (recast of CE directives and regulations, Eco-design, General product safety, Liability for defective products).
  • Product risk assessment in the development and post-production phase, the concept of functional safety.
  • Control of conformity of products during a batch production
  • The correct application of harmonized standards in the design and manufacture of products,
  • Documenting compliance and the availability of a technical file
  • Demonstration of conformity – the tasks of the manufacturer and the role of the notified body,
  • Preparation of instructions for use
  • Preparation of an EC declaration of conformity
  • Marking requirements and when the CE mark appears

Preparation of a case study
Until the next meeting, the participants prepare a short, focused study on the requirements for compliance of a selected product from their work environment, which they then work on together with the lecturer during the second part of the workshop.

Day 2

  • Recognition of New Approach directives and ways of allocating relevant standards.
  • Use of generic and product standards.
  • Risk assessment, evaluation of the adequacy of technical measures and their recording through the preparation of risk assessment documentation.
  • Managing relations with suppliers and service providers to ensure/assess compliance.
  • Preparation of model instructions for use.
  • Rights and duties in the designer (constructor) – manufacturer (manufacturer) – installer (assembler) – integrator relationship.
  • Rights and obligations in the manufacturer – authorized representative – importer – distributor – trademark holder relationship.
  • Requirements for imports from third countries and the status of used equipment.
  • Responsibilities of online providers of technical goods.
  • Techniques for recognizing the authenticity of technical documentation or product modifications (a gap between ‘certified’ and actual).
  • Frequent errors and identified good practices of economic operators.
Lecturer

Mr Janez Furlan a professional in conformity assessment and compliance engineering of technical products with over 18 years of unique combination of experiences in public and private sector. Have achieved Level 8 education in Mechanical Engineering with certified excellent command in English and highly skilled in training and presentations. Gained thorough knowledge in vast EU technical regulations through education in twinning projects as a test engineer and head of laboratory, got deeper insight in standardization of new technologies as a member of Notified Bodies, experienced, daily practising CE marking projects as a compliance engineer and participated in numerous development aid projects in accession and development countries. Author of booklet on machinery safety. In the last decade, Mr. Furlan delivers business consultancies to the SMEs and start-ups in international trade and competitiveness issues. Has successfully supported dozens of companies in their growth and up-scaling. Follows trends in industrial engineering (fast prototyping) and production (Industry 4.0. concept) and praises inclusive approach of stakeholders to achieve sustainable growth of the young businesses.

The online training will take place in a live online e-classroom.

Who should attend?

All of you in charge of developing technical products.

Quality managers in development and production companies.

Agents, trademark holders and importers of technical products from non-European manufacturers.

Online stores.

Anyone who wants to acquire, update or upgrade their knowledge of CE marking and product compliance

Apply now