There are many routes open to achieving a CE mark for a medical device. Factors that influence the route include the classification of the device, the costs involved in clinical investigation or clinical evaluation and the intended use of the device.

All products are required to meet the general safety and performance requirements of medical device regulations

Kinesys assists in the development of trials, programmes and activities needed to meet CE Certification requirements as required by the European Medical Device Regulations (2017/745) and IVD Regulations (2017/746)

Services we offer include:

• Regulatory Roadmaps
• Technical documentation preparation, including Clinical Evaluation Reports and Risk Management Reports to meet required standards and guidance
• Gap analysis of existing regulatory technical documentation
• Technical writing to fill any gaps in documentation
• Pre-submission review of the Technical Documentation
• Corrective action advice for any issues highlighted by a Notified Body