The seller has placed devices in the European Union (EU), must accept or apply CE Marking on product. Before you can offer your medical products for the European Union (EU) and the European Free Trade Association, you first have to meet the requirements of the CE mark, a conformity mark indicating that a product complies with all EU policies Relevant, especially in the areas of safety and performance. The CE mark is a legal designation that the manufacturer’s product has met the requirements of all relevant Medical Device Directives in the European market to obtain CE certification.
The CE mark indicates this product compliance with applicable EU regulations and allows products to be marketed in 32 European countries. As a legal manufacturer of medical devices, has been responsible for maintaining the CE marking rules and the CE marking on the product, regardless of whether it is subordinated or qualified for the operation of manufacture.
How to obtain the CE mark for the medical device
CE does not a quality brand, but the EU directive requires that this compliance be carried out with the help of the standard to performance, safety, quality and efficiency in the type of product. The basic steps for process are following:
- Determine which EU Directive applies to your device: Medical Devices Directive (93/42/EEC), In Vitro Diagnostic Devices Directive (98/79/EC) or Active Implantable Medical Devices Directive (90/385/EEC)
- Determine the classification of the device
- Implement a Quality Management System as applicable on a device. Major Representative uses ISO 13485 for the case with the requirement.
- Select and Designate an Authorized European Representative for those jobs within the EU, there is no physical location in Europe.
- Have your QMS and the technical file/archive audited for a notified body, a means that on the device see of class I.
- The CE certificate and the ISO 13485 certificate are notified by the organization
- Prepare a Declaration of Conformity (DoC), which declares that your device compiles with the appropriate directive.
In this post I have shared information regarding CE marking for medical device. I am working currently on “CE Mark for Steel structural as per EN 1090 and ISO 3834” project, so I am currently gathering some more relevant information through my experience about it. You will read such information about CE for steel structural and DIN EN 1090 and ISO 3834 requirements in my next blog.
CE Mark Product Certification Procedures 