This short course will introduce manufacturers to important concepts and requirements that must be understood in order to successfully manufacture products for and sell products into European Union markets.
We will provide an overview of the European Union and how it differs from other markets around the world, how those differences impact regulations and the regulatory approach, and how they should be interpreted and understood in the context of the EU market. The New Legislative Framework is also introduced. This regulatory framework is a systematic approach to ensuring the safety of products that are placed on the market in the EU. Important concepts such as essential requirements, harmonised standards, technical documentation and the EU Declaration of Conformity are covered.
The course will cover:
- Directive vs Regulation vs Decision;
- the “new legislative framework” (NFL);
- harmonised standards; and
- technical documentation.