The CE Certification procedure for medical devices products which are put into use in the European Union must be in compliance with the essential requirements and procedures which are indicated in the applicable medical CE marking Directives. Several different routes can be followed to achieve a correct classification and certification of a medical product. The actual certification process consists of several different steps to satisfy the needs of specific medical product classifications. The medical devices classified under the scope of the Medical Devices Directives must result in the proven safe use of the products.
To legally result in the achieving of a CE mark, each product (or closely related family of products) must be assessed uniquely. In order to adequately classify the medical device, important information in form of a Technical File must be provided before the products can be approved for a CE Marking.
Technical File – A Technical File must be compiled in compliance with the applicable CE marking Medical Devices Directives. The Technical File contains all the relevant product specifications and related details, and available validation and verification data for the Medical Device Product.
Risk Assessment – Part of the Technical File is a risk assessment. A Risk Assessment must be carried out by the producer on the medical device and must include information such as construction evaluation, materials used, bio-compatibility analysis, infection and cross-infection risks, and potential risks during use.
Quality Assurance – Relating to the classification of the medical device products, an official Quality Assurance System (QAS) must be implemented in compliance with the Medical Devices Directives to demonstrate a suitable and acceptable production for the products concerned.
CE Medical can fully support and assist your company in retrieving, generating and compiling the necessary information for the Technical File and subsequently, when applicable, get the Technical File assessed by the designated bodies through our worldwide network.
Do not hesitate to contact us for a non-committal product assessment and/or quotation of your medical device product.
Notified Body