CE marking
OF MEDICAL DEVICES
As a general rule, products must be provided with CE marking to show their compliance with the regulation. They can thus move freely within the Union and can be put into service according to their intended purpose. Member states must not create obstacles to the placing on the market, or putting into service, of products that meet the requirements established in the European Implementing Regulation (MDR and IVDR), in relation to the type of product, however they will have the power to decide whether or not to restrict the use of a specific type of product not included in the regulation.
Any manufacturer of a medical device shall document and keep the technical product file up to date. Such technical documentation, and other legal requirements, will be the responsibility of the company’s guarantor technician , together with the guarantee of compliance with requirements.
Once compliance with the product requirements and the intended purpose of the product have been documented, the application will be forwarded to the Notified Body (ON) selected for the management of the CE marking of the product. The ON will review the documentation, having it edited if deemed appropriate, to finally issue the certificate.
The manufacturer, within his documentation, will have identified a type of device, its classification and the conformity assessment procedure of the medical device, data verified and confirmed by the ON and the competent authority of the state concerned.
Prior to placing on the market, it will be necessary to carry out the prior operating licence and, once marketing has begun, the mandatory notification of placing on the market, before the AEMPS (Spanish Agency for Medicines and Medical Devices), in the case of the Spanish market.
An essential requirement for the manufacturer is, in addition to the preparation and updating of the documents required by legislation and the implementation and maintenance of the quality management system, the design and application of a post-marketing surveillance system.
As a certification of compliance with all application requirements, for each product manufactured by the company, the company issues the declaration of conformity, always drawn up under its sole responsibility.
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