For manufactures and distributors of all types of products looking to enter the European market, it can sometimes feel like there is so much to know about compliance, standards, and expectations inside the EU. Guidelines for market placement and post-placement procedures can often feel unclear to some, especially when it comes to what we call the ‘New Approach’ directives. With that in mind, in this blog we’re going to provide a little insight into just what these directives are and how they work.

In the most simple sense, the New Approach directives are a series of legislative requirements that are in place to ensure ultimate product safety on the European market, to protect both consumer and manufacturer. First adopted by the European Union in 1985, the directives are most easily recognisable by their legislating for the requirement of a CE Mark (for products) and an Authorized Body (for manufacturers), also called for under the New Approach directives is the instating of Notified Bodies as invigilators for pre-market approval and surveillance.

As outlined above, the main goals of the New Approach directives are to standardize and harmonize regulations and guidelines for all products on the EU market as regards consumer safety and the public interest. They do this by installing and enforcing a set of requirements all products/manufacturers must adhere to before they can be officially placed within a European member state. The comprehensive directives cover an endless array of products on the European market, including: cosmetics, medical devices, in vitro devices, implants, construction products, toys, motor vehicles, machinery, radio equipment, and much more (a full list of New Approach directives and regulations can be found on:

It is worth noting that while compliance with the New Approach directives within Europe is mandatory, the system does work on a ‘presumption of conformity’ basis. The result of this is that sometimes non-compliant products may make it to the EU market, but those found to be so are removed – often causing much undue stress and extra work for manufactures, as well as lasting damage to their reputation within Europe.

The lasting impact of the directives has been powerful, not only in ensuring the success of a standardized set of product regulations, but in facilitating the largely free movement of products within all EU member states and further developing the single European market. A useful tool for compliance notification and vigilance developed in line with the directives is the RAPEX database, the platform is open to the general public and provides a valuable services to both the consumer/retailer as a transparency tool and to the manufacturer as a means of keeping up to date with compliance issues and avoiding the consequences that come with non-compliance.

For more information on any aspect of the New Approach Directives and how they may impact your product’s placement within Europe, to enquire about Obelis’ Authorised Representative or CE Marking services, or for advice from our team of legislative experts, contact us today.

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