EU MDR risk management
EU MDR risk management requirements can be implemented with the help of the harmonized standard EN ISO 14971. The manufacturer must ensure risk management activities are carried out. He must update it periodically and systematically throughout the life cycle of each device[1].
In order to ensure risk management, the manufacturer must:
- establish and document a risk management plan,
- identify and analyze known and foreseeable hazards,
- estimate and assess the risks associated with the intended use and misuse reasonably foreseeable,
- eliminate or control risks as much as possible.
It may rely on the relevant harmonized standards published in the OJEU related to risk management, the compliance to which presumes conformity.
The principles to be applied for risk management are detailed in Annex I, sections 3 to 5 of the European Medical Device Regulation 2017/745 regulation.
EU MDR Risk management and ISO 14971:2019
The European Commission has published its views regarding the state of the art. What they are saying is that the latest version of the standard should be used (harmonized or not). Therefore, since ISO 14971:2019 has been published, it shall be used and replace EN ISO 14971:2012. In fact, there is no transition time for this standard so it should be applied immediately by Notified Bodies.
[1] Article 10, point 2 Regulation 2017/745.
You may go back to our EU MDR guide.
If you are interested in the European market you can contact us for a preliminary discussion. You can also look at our dedicated page for European medical device registration.
