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To sell medical devices which already have a CE mark certification, but with your own branding on the label, your organization must apply for its own certification.

Medical device

To assist you in bringing products to market, SGS offers CE Mark certification for the own brand labeling of medical devices.

Our process for medical devices own brand labeling certification is in many instances by document review. Contact your local SGS medical devices office at the earliest opportunity to discuss your products and gain a full understanding of your certification requirements.

Own branding is a common practice for medical devices. Often the own brand labeling company is situated in Europe and the original manufacturer (often called the OEM) situated outside Europe. Certification is needed by the own brand labeler because, under EC directives, you become the legal manufacturer and take on all the legal responsibilities. A useful guidance document is produced by the UK Competent Authority (MHRA).

SGS has over 15 years’ experience with own brand labeling for medical devices certification, and can provide advice, training and your certificate in dual language, local and English, to meet your legal obligations. With a presence in every single region around the globe, our experts speak the language and understand own branding in many markets.

Sell your own brand medical devices with CE Mark certification from SGS.