Necessity of implementing ISO 14971 to obtain ISO 13485

Yes, it is necessary to implement ISO 14971:2012 Medical devices — Application of risk management to medical devices. This standard is the only standard on the list of harmonized standards that talk about risk. Since all manufacturers of medical devices need to be in compliance with a list of harmonized standards published by the European Commission, it is obligatory to have implemented this standard.

For more information, see:

• EU MDR Article 8 – Use of harmonized standards - https://advisera.com/13485academy/mdr/use-of-harmonised-standards/
• List of harmonized standards https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices_en