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Regulatory: what is CE marking? The CE marking as it has been legally called since 1993. "European Conformity" formerly EC mark is a mandatory conformity mark for products placed on the market in the European Economic Area. With the CE marking on a product, the manufacturer ensures that the product conforms with the essential requirements of the applicable EC directives.

CE marking is a key indicator of a product’s compliance with EU legislation and enables the free movement of products within the European market. By affixing the CE marking on a product, a manufacturer is declaring, on his sole responsibility, conformity with all of the legal requirements to achieve CE marking and therefore ensuring validity for that product to be sold throughout the European Economic Area (EEA, the 27 Member States of the EU and EFTA countries Iceland, Norway, Liechtenstein), as well as Turkey. This also applies to products made in third countries, which are sold in the EEA and Turkey.

However, not all products must bear the CE marking. Only those product categories subject to specific directives that provide for the CE marking are required to be CE marked.

CE marking does not indicate that a product was made in the EEA, but merely states that the product is assessed before being placed on the market and thus satisfies the legislative requirements (e.g. a harmonised level of safety) to be sold there. It means that the manufacturer has verified that the product complies with all relevant essential requirements (e.g. health and safety requirements) of the applicable directive(s) – or, if stipulated in the directive(s), had it examined by a notified conformity assessment body.

It is the manufacturer’s responsibility to carry out the conformity assessment, to set up the technical file, to issue the EC declaration of conformity and to affix CE marking on a product. Distributors must verify the presence of both the CE marking and the necessary supporting documentation. If the product is being imported from a third country, the importer has to verify that the manufacturer outside the EU has undertaken the necessary steps and that the documentation is available upon request.

The Regulations implement the EC Medical Devices Directives into UK law. They place obligations on manufacturers to ensure that their devices are safe and fit for their intended purpose before they are CE marked and placed on the market in any EC member state.

There are currently four sets of Medical Device Regulations implementing all of the Medical Devices Directives and amendments to date; Statutory Instruments 2002 No. 618 (Consolidated legislation), 2003 No. 1697 (Amendments to cover the re-classification of breast implants and additional requirements covering devices utilising materials from TSE susceptible animal species), Medical Devices Regulations 2007 No. 400 (Amendment to cover the re-classification of total hip, knee and shoulder joints) and the Medical Devices (Amendment) Regulations 2008 No 2936 which transpose Directive 2007/47/EC into UK law, were passed by Parliament in December 2008 and fully come into force in March 2010. They have been issued under the Consumer Protection Act and can be found on the Office of Public Sector Information (OPSI) (external link) website.

MacGregor Rogers can help guide you through the regulatory approval process and introduce you to our partners who can work with you to gain CE mark.

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