CE Certificate

Medical Device Directive 93/42/EEC (MDD) covers almost all medical devices excluding Active Implantable Medical Devices (AIMD) and In Vitro Diagnostic Devices (IVD), such as non-active medical devices (dressings, disposable products, contact lenses, blood bags, catheters, etc.) and active medical devices such as nuclear magnetic resonance spectrometers, ultrasound devices for diagnostics and therapy, infusion pumps, etc.
The process of CE certification according to the Medical Device Directive (MDD):
1 Medical devices are classified in categories I, IIa, IIb and III according to their risk classes in accordance with the 18 rules set out in Annex IX of the Medical Device Directive 93/42/EEC (MDD)
•    Class I: low-risk products, non-invasive products such as external patient support products
•    Class IIa / b: medium risk products, e.g. electronic medical devices
•    Class III: high risk products such as Cardiac catheterization
* Caution: some products of class I  and all products of class IIa, IIb and III must be approved by a certification authority.  
2 The certification process is depending on the type of product / device.
3 Compliance with Essential Requirements - Make sure that your medical device meets the essential requirements set out in Annex I, 93/42/EEC.
4 Preparation of the relevant technical data, documentation and certificates for inspection and review by the competent authorities for spot checks, or for use in disputes and litigation.
●Company profile, quality manual, program documentation
●Power of attorney as European Authorised Representative including the name and contact details
●Declaration of conformity
4.1  Brief description of the product name, classification and reference standards and conditions
4.2  Product overview (including product type and intended use)
4.3  Appliance standards of products
4.4  Conclusion for risk assessment and preventive measures
4.5  Quality control in manufacturing  
4.6  Confirm the completeness and normality of the product packaging, label and instructions manual in order to comply with the relevant regulations.
4.7  Technical documentation - Product test reports, technical data and related literature
4.8  potential risks and clinical evaluation - potential risk test reports, clinical assessment and related literature for the product
5 Building a Vigilance and Incident Reporting System - as a manufacturer, you must supervise your products constantly after they have been placed on the market to avoid incidents with your product. In the event of an incident or a near-incident with your product, you are obligated to report it to the authorities.
6 All documentation mentioned above must be secured by the European Authorised Representative and kept for at least five years. - According to the new edition of MDD, records of implantable medical devices must be kept for at least five years. After expiry of the product, the declaration of conformity, the technical documentation, the reports and the certificates of the notified body must be kept for at least five years.
7  Product registration in the competent european authorities