Online Workshop: 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 studyUntil 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 Miha Otrin, Ph.D., earned his doctoral degree at the Faculty of Mechanical Engineering, Department of Mechanics, University of Ljubljana. His work was experimentally and theoretically oriented to the field of analysis of the vibrational state of products. After finishing his studies, he worked for a brief time for Cimos, d. d., where he performed climate-mechanical testing in the development department of the Testing Laboratory. Since 2009, he has been employed at SIQ Ljubljana as the Head of the Laboratory of Electrical and Mechanical Engineering. Here, he conducts procedures for determining and ensuring the conformity of machines and devices, including functional safety checks. He is an expert in risk assessment of various products, both new and those that have undergone changes and upgrades. As the Head of the Unit for the verification of interoperability of railway subsystems, he also performs verification procedures of railway vehicles and components. He is an ISO 17025 internal auditor and has passed the exam for an ISO 9001 lead auditor.

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