Determining product requirements is the first crucial step towards compliance.
→ TYPES OF ECONOMIC ACTORS
→ DETERMINING REQUIREMENTS
→ EXAMPLE FROM PRACTICE
→ REGULATORY ESSENTIALS & ONLINE FINDER
The conception and market launch of new products is a challenging and responsible task. As a first step, it is essential to determine the relevant product compliance requirements quickly and thoroughly. Determining the existing legal regulations and identifying applicable standards is a time-consuming process. In addition, market access conditions place individual requirements on each economic operator. The manufacturer has different obligations than the importer or distributor.
Since 2019, there have been five types of economic operators. Even before the determination of requirements starts, it must be clear which role(s) you play.
Manufacturers - whether located inside or outside the EU - have the option of appointing an authorized representative in the EU. This authorized representative can take on certain tasks on their behalf, including cooperating with the national market surveillance authority and providing the necessary documentation to demonstrate product conformity.
A manufacturer can be either a natural person or another legal entity that produces or commissions the development and manufacture of a product and then markets it under its own name or a trademark.
An importer is any natural or legal person established in the EU who places a product from a third country on the Union market. The importer's responsibility includes ensuring that the manufacturer fulfills the corresponding obligations in relation to the products it imports.
Warehouses and fulfillment service providers offer storage and shipping services for e-commerce. A service provider that handles packaging, shipping and returns can be considered a retailer and must fulfill the associated obligations.
A distributor is a person or company within the distribution chain who offers products on the EU market after having purchased them from a supplier such as a manufacturer, an importer or another distributor.
Equally important is a comprehensive analysis and an understanding of the product requirements, both in terms of their breadth and depth in detail.
Horizontally, the requirements range from product-related technical safety and environmental compatibility to company organizational aspects.
It must be ensured that all industry-specific regulations are identified and analyzed from the outset in order to prevent conflicts with market surveillance authorities and customs as well as product liability proceedings.
Dipl.-Ing. (FH) Michael Loerzer
Regulatory Affairs Specialist
and certified Product Compliance Officer
in accordance with ISO/IEC 17024
"We often receive inquiries from small and medium-sized companies that they can no longer find their way through the jungle of regulations.
Our Regulatory ESSENTIALS bring this complexity into order, making regulations from different regions comparable and much easier to digest. Our customers quickly find their way back from a state of being overwhelmed to being able to work and having a certain clarity of vision."
Frequently asked question: Do I always have to comply with all the details of the technical standards or can I also go my own way in product design?
Expert tip: Technical standards are usually applied voluntarily, but can certainly become binding through national legislation. An adequate risk assessment for the product design opens many doors here.
Do you lack up-to-date information on the regulatory requirements of your international target markets?
Do you have not enough time and human resources to acquire this important knowledge?
Are you really able to assess whether the information you have researched comes from official sources and is up to date or not?
Modular information packages with essential information for compliant products in your target markets, incl:
Accessible online at any time on the ROGER WILLCO product compliance portal.
Your advantages
Immense time saving
Valuable know-how development
Current and correct information
Know what to do!
Combine subject areas and target markets for your products now and find out which Regulatory ESSENTIALS will help you!
DO YOU HAVE ANY QUESTIONS?
Our Regulatory ESSENTIALS team will be happy to help you:
Phone: +49 30 3229027-50
Email: essentials@globalnorm.de
Over 18 subject areas
Accessible online
More than 29 countries and economic areas
Regularly updated
Combine the legal areas and target markets relevant to you and create a knowledge database for your globally compliant product portfolio!
Subject areas:
Countries and economic areas:
Accessible online from anywhere:
You can conveniently read the Regulatory ESSENTIALS information online in the ROGER WILLCO product compliance portal.
Combine the relevant subject areas and target markets for your products in our online finder and submit a non-binding inquiry!
Do you want to find out specifically which subject areas and target markets you can use Regulatory ESSENTIALS for?
You can obtain non-binding advice online here in just 3 simple steps and then send us an inquiry:
All information is compiled by a team of experienced product and material compliance experts. It contains only relevant, up-to-date and verified information in English and is checked and updated at regular intervals.
Dipl.-Ing. (FH)
Michael Loerzer
Regulatory Affairs Specialist
B.A.
Linda Kritzler
Material & Environmental Compliance Consultant
Fully qualified lawyer
Inken Green
Product & Material Compliance Expert
B. Eng.
Benjamin Kerger
Product Compliance Expert (EMC, radio, safety)
Dipl.-Ing. (FH)
Torsten Sahm
Product Compliance Expert (EMC, radio, automotive)
Dipl.-Ing. (FH)
Anette Dunkel-Reinboth
Regulatory Analyst
Glossary
ATEX stands for "Atmosphères Explosibles", a French term that aims to prevent explosions to protect people, the environment and machinery. The ATEX directives are applicable to all devices, machines and protective systems that are used in potentially explosive environments.
This means that you can prove that the products meet the basic requirements of the directives, regulations and harmonized standards.
The term market access requirement refers to the conditions that must be met for a company or product to become active in a particular market. These conditions can depend on various factors and vary depending on the industry, region or market segment.
The declaration of conformity is a written confirmation that is issued at the end of a conformity assessment process. In it, the person responsible declares and confirms with binding effect that the object in question (be it a product, a service, a facility or a quality management system) fulfills the characteristics specified in the declaration.
