CE Marking and ISO 13485 Document Checks for Medical Products

CE marking and ISO 13485 documentation cover different subjects. Match the product identity to the scope of each document in your purchasing file.

What does CE marking mean?

CE indicates the manufacturer's declaration that a product meets the applicable EU requirements. It is not an EU-issued safety approval. Not every product requires CE marking; assess its intended purpose and applicable legislation.

What does ISO 13485 cover?

ISO 13485 is a quality management system standard for organizations in the medical device sector. An organization's certificate does not replace a product's conformity documentation.

What should you request with a quotation?

• Manufacturer, model and product code matching the quote, label and documentation.
• Applicable declaration of conformity and any relevant certificate, with scope and validity checked.
• Manufacturer's data sheet, instructions for use and packaging details.
• Batch/lot identification, expiry date and storage conditions.
• Product-specific verification of applicable registration information for Turkey.

Include the product code when requesting documentation from Clinimate. When a brand or model changes, check that the documents refer to the replacement product.