Medical Device CE Marking

Medical Device 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 be legally circulated on the European market, we can assist you in the preparation of technical documentation to enable you to achieve CE marking.

CE marking is required in the European Union (EU) and 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 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.


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QUALITY - Supplier Audit

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Environment -  ISO 14001

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At SGR we can help you with your HACCP (Hazard Analysis and Critical Control Point), it is a system that introduces better food safety to your organisation’s activities when handling food productsand how food is produced to make sure the food is safe to eat.


Consulting Services Ltd

Implementation and maintenance of Management Systems that meet the requirements of: ISO 9001, ISO 13485, ISO 14001, OHSAS 18001 and PAS 99.

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