What characterizes the MDR?
The Medical Device Regulation’s main goal is to increase patient safety in Europe. It achieves this through:
- Increased evidence of compliance
The European Union expects much more solid and scientific proof that medical devices live up to the purposes they were developed for.
Manufacturers must prove that they use complaints and market information to continuously improve the safety of their products.
- State-of-the-art lifecycle approach
Any product that is available on the market must meet the current regulations and standards, at any moment in their lifetime – so not just at the time of their initial go-to-market launch.