Rechtsverbindliche Konformitätserklärungen korrekt erstellen

Correctly drawing up legally binding declarations of conformity
Requirements in the EU, UK and other markets - with best practice: Bill of materials-based declarations of conformity in the product life cycle

(Please note: This publication is only available in German.)

A global business environment requires adapted regulations to ensure security and consistent standards. The declaration of conformity is one of the most important instruments in this process. It confirms the conformity of the product characteristics with the requirements of the economic area into which the product is to be imported and authorizes CE marking in Europe.

Mistakes made in declarations of conformity can have considerable legal and financial consequences. DIN Media has therefore published a useful practical guide, "Correctly drawing up legally binding declarations of conformity”, which provides everything that those responsible for production and import need to consider in a compact volume. “Creating legally binding declarations of conformity correctly” also offers a best practice that explains the bill of materials-based declaration of conformity method in detail.

The book contains expertise on the following aspects:

• drafting EU declarations of conformity in accordance with the relevant EU legislation
• minimum specifications
• specific requirements of individual harmonization legislation
• requirements for UKCA marking since Brexit
• maintenance process for declarations of conformity for industrial serial products with high product variance
• creating and maintaining declarations of conformity for other market regions

The book and the DIN Mediathek also contain numerous sample templates for products with references to various EU regulations.
 

In-depth expertise and simple instructions

The European harmonization legislation in accordance with EU Regulation 2019/1020 [1] requires the declaration of conformity for products to be imported. Those responsible for introducing products, such as manufacturers, importers, authorized representatives or fulfilment service providers, are obliged to have the declaration of conformity/declaration of performance drawn up and to keep it available. The information in this book is intended to help you draw up legally binding declarations of conformity. The standard used for this is DIN EN ISO/IEC 17050-1, and its role is also presented in this guide. In this book, you will find:

• Easily understandable basic knowledge
  From the manufacturer's obligations to terminology, CE marking and the various roles in the import process through to certification and authorization, the book explains the basics of conformity assessment.
   
• Practical expertise
  How is a declaration of conformity made? For how long and where is it valid? What transition periods apply? These and similar questions are answered in a practical and comprehensible manner.
   
• Further legal framework conditions
  The import of many products is regulated by further directives and regulations. The book presents the various requirements, e.g. for medical products or toys.
   
• Best Practices
  The guide takes you step by step through a best-practice example and clarifies aspects such as risk assessment, the relevant standards, technical product documentation and data management based on the bill of materials-based EU conformity process.

“Correctly drawing up legally binding declarations of conformity” is a comprehensive guide that is an irreplaceable work aid due to its clarity and high practical relevance as well as the customizable sample templates.
 

Included in this book:

• Authors
• Foreword
• European single market and technical harmonisation
• Conformity assessment — Declaration of conformity from suppliers
• Application rules for the harmonized standards
• Specific requirements for the content of the EU declaration of conformity for individual harmonization legislation
• UKCA requirements in the United Kingdom
• Best practice:  Bill of material-based declarations of conformity in the product life cycle
• FAQs
• Annex

This book is for:
Product life cycle management, development and design departments, QM departments, management of companies that manufacture products subject to marking requirements, as well as all other medium-sized and large companies with an extensive product portfolio that is subject to statutory marking requirements