Documentation Requirements for Medical Devices
To obtain CE marking of a medical device, the manufacturer must provide various forms of documentation, including:
- Technical documentation of the product
- Risk analysis
- Clinical assessment
The documentation requirements depend on the type of product and its risk class, among other things. Read more about CE marking here.
Risk Analyses and Tests
The development of medical devices is a structured process, where the planning and execution of risk analyses play a main role. Risk analyses are conducted at all stages of the process and concern the utilisation, design and production of the device.
Depending on the type of product, the purpose of the product and its risk classification, it is necessary to do a series of tests. This may e.g. include testing of mechanical and electric control functions, electromagnetic radiation tests, biocompatibility test, toxicological tests, service life tests (accelerated ageing tests), transport tests, fall and breakage tests.
Sterile products are also subjected to a series of tests and validation of the chosen sterilisation method.
Finally, the finished product is validated in a user study, and all the results form part of the manufacturer’s documentation for the authorities/notified body in connection with certification.
Clinical Testing of Medical Devices
The regulation for medical devices demands clinical data for products in all risk classes. This means that new medical devices must – just like new medicine – be tested on humans in clinical tests.
A clinical test of medical devices constitutes:
A test on humans for the purpose of establishing or validating the safety and/or performance of the device.
Initially, the Danish Health Authority and the National Committee on Health Research Ethics must authorise the test.