The Medical Device Regulation (EU) 2017/745, also known as the MDR, sets out the essential safety and performance requirements for medical devices intended to be placed on the market in the EU. Annex 1 of the MDR sets out specific requirements for the safety and performance of medical devices.
Some of the most important requirements according to Annex 1 of the MDR are:
- The use of safe and suitable materials and components,
- the fulfilment of requirements for the design and functioning of the device,
- the guarantee of adequate user-friendliness,
- fulfilment of requirements for the safety and performance of the software that is part of the device,
- the fulfilment of appropriate sterility and biosafety requirements,
- meeting requirements for documentation and labelling of the device,
- fulfilment of conformity assessment and post-market surveillance requirements.
It is important to note that the MDR takes a risk-based approach, which means that the requirements for the safety and performance of medical devices are dependent on their risk profile. Devices with a higher risk profile must fulfil stricter requirements than devices with a lower risk profile.
In any case, it is important that manufacturers ensure that their medical devices fulfil the requirements of the MDR before they are imported into the EU. This includes carrying out conformity assessments and complying with post-market surveillance regulations.
