The "CE Marking" demonstrates that a product conforms with the essential requirements set in the EU. This means that the product is safe and fit for the purpose for which it was made. As part of the "New Approach" to technical harmonization in the EU, directives have been established for medical devices. These directives specify requirements which must be met before permission is granted to apply the CE marking to your medical device and placing it on the market. The directives which apply to medical devices are:

• Active Implantable Medical Device Directive (90/385/EEC)
  This directive covers all medical devices, which rely for their functioning on a power supply and are left in the human body. Examples of AIMD's are implantable cardiac pacemakers, implantable nerve stimulators and implantable drug administration devices with or without catheter.
• Medical Device Directive (93/42/EEC)
  The Medical Device Directive covers most other medical devices (active and non-active) and their accessories that are not covered by the first or the third directive. This concerns a large number of products ranging from walking aids to prosthetic heart valves.
• In Vitro Diagnostic Medical Device Directive (98/79/EC)
  The In Vitro Diagnostic Medical Device Directive will cover any reagent, reagent product, control material, kit, medical device, instrument, apparatus or system which is intended to be used in-vitro for the examination of substances derived from the human body.

For more details of the route to acquiring a CE Marking please click here.

Regulatory Affairs

• CE Marking of medical devices conform the European Medical Device Directive(s)
• Choice of your Notified Body
• Device classification
• Conformity route assessment
• Gap analysis
• Representing your company to national and international regulatory authorities
• Regulatory studies advice, e.g., Pre-clinical testing, clinical, shelf-life, labeling, packaging and sterilization
• Design and risk analyses
• Advice on the implementation of a Complaint, Recall, and Vigilance system
• Post Market Surveillance (PMS) system

Technical File

• Preparation and submission of CE Technical file(s) and CE Design dossier(s)
• Advice on and evaluation of the Risk Management system
• Advice on and review of the Essential Requirement(s)
• Labeling and language compliance
• Declaration of Conformity
• Expert reports and other technical documentation

Submissions

• European, US and worldwide strategic regulatory affairs in association with Qserve America

Management Support

• Auditing compliance
• Recall compliance
• Complaint handling and vigilance compliance
• Management review compliance
• Validation compliance
• Continual improvement compliance

Quality Management Systems Support

• Auditing compliance
• Recall compliance
• Complaint handling and vigilance compliance
• Management review compliance
• Validation compliance
• Continual improvement compliance

Qserve Consultancy offers various courses and training in the above. For additional information please read more here.