CE marking

At SGR we have over 15 years’ experience in the medical industry and are able to offer assistance with the creation of technical files, risks assessments in accordance with ISO 14971, meeting the
essential requirements of the medical device directive, auditing and product testing.

A CE mark is needed for many medical products in the European Economic Area (EEA), the letters ‘CE’ on a product show that the product complies with European legislation. CE marking was created at the beginning of 1992 to help free the restrictions of the European Marketplace. The CE mark ensures that the product is safe for the market, reassures the buyer of the products
safety compliance and could potentially reduce the risk of liability claims. CE marking allows the product to legally be circulated on the European market, we can assist you in the preparation of
technical documentation to enable them to achieve CE marking.

CE marking is required in the European Union (EU) member states and the European Economic Area countries (EEAC).

The countries that require CE marking are:

  • Austria
  • Belgium
  • Bulgaria
  • Cyprus
  • Czech Republic
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Lichtenstein
  • Lithuania
  • Luxemburg
  • Malta
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • The Netherlands
  • United Kingdom

In the future, there is likely to be an addition of more countries that require CE marking.

What are the benefits of CE Marking?

The implementation of the CE Mark for your product will enable your company to realise a variety of benefits such as the ability for the product to move freely within European Economic Area (EEA) and the European Free Trade (EFT). CE marking is a legal requirement for many products globally, this makes CE marking essential. The CE mark ensures the product will be compliant within the
European Economic Area (EEA), another great benefit would be assurance of safety which could result in the reduced risk of liability.

We will be with you every step of the way and can offer you many other products, services and expert consultation. We are widely recommended by a variety of companies for our
outstanding services, work ethic and initiative for excellence.