European Directives: The Basic Knowledge You Need To Have

The European directives represent the laws that all manufacturers must meet before they are allowed to affix CE Marking to their products. Each directive can be identified with a year and an identifier number. For instance, the Low Voltage Directive (LVD) has the identifier 2014/35/EU, which means that this European directive was the 35th published in 2014. All European directives are subjected to a short transitional period of 2-3 years before being adopted. This means that although the LVD was published in 2014, it didn’t come into force until 2016.

The European directives, also known as policy decisions made by the Council of European Communities, define the Essential Health and Safety Requirements that all economic operators must meet before products are placed on the EU market. They specify in details what needs to be done from a procedural and legal standpoint. Moreover, within the scope of each EU directive can be found information in regards to what would happen if the laws are ignored.

The European directives are associated with the following principles of CE compliance:

• Products and specifically their design and instructions should comply with the applicable essential requirements of the respective EU directive;
• Economic operators, such as manufacturers or suppliers, must demonstrate the products’ compliance by using one or more of the conformity assessment modules described in the specific directive;
• Products should have CE Marking affixed on them legibly and permanently;
• Economic operators, in most of the cases - manufacturers, need to prepare and sign a Declaration of Conformance by which they will legally declare products’ CE compliance.

The focus of the European directives is on, as follows:

• Providing a high level of product safety;
• Covering issues, such as the appropriateness of the conformity assessment modules to the type of products and the nature of the risks involved;
• Setting out the criteria governing the conditions for products’ manufacturing;
• Providing manufacturers with a wide range of CE compliance options;
• Etc.

In some cases, and in particular when it comes to CE compliance of medical devices, the specific European Directives (e.g. MDD, IVD, AIMDD) include provisions for the appointment of Notified Bodies. For many of the EU Directives, the involvement of Notified Bodies is only mandatory for higher-risk and safety-critical products.