Technical Documentation composition
Part of every conformity assessment procedure of medical devices is the composing of the Technical Documentation. One of the general obligations for manufacturers of medical devices is that they shall draw up the Technical Documentation and keep it up to date. The Technical Documentation shall be such as to allow to assess the conformity of the medical device with the requirements of the applicable legislation.
Content of Technical Documentation
The exact content of the Technical Documentation for your medical device depends on the specifications and intended use. However, the following documentation are examples of documentation that could be included in your Technical Documentation:
- A description and specifications of your medical device.
- The instructions for use.
- The labelling.
- Risk analysis.
- (Pre-)Clinical data.
- All tests and/or studies conducted.
Are you bringing a medical device onto the European market? It is a legal obligation of the manufacturer to ensure that the Technical Documentation is drawn up and up to date. CE Medical can assist you with the composition and drawing up of the Technical Documentation to ensure legal compliance.
Contact one of our experts now to discuss the possibilities regarding the Technical Documentation of your medical device.