Other ISOs used by the medical devices

Aside from the ISO 13485:2016, all medical devices need to be in compliance with the applicable harmonized standard. The list of harmonized standards is published by the Official Jurnal of the European Union. According to Article 8 of MDR 2017/745 – use of harmonized standard, medical devices must be in compliance with relevant harmonized standards, or the relevant parts of those standards, the references of which have been published in the Official Journal of the European Union.

The following harmonized standards are applicable for all manufacturers of the medical devices:

• EN 1041:2008 Information supplied by the manufacturer of medical devices
• EN ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes
• EN ISO 14971:2012; medical devices - Medical devices — Application of risk management to medical devices
• EN ISO 15223-1:2016 Medical devices — Symbols to be used with medical device labels, labeling and information to be supplied — Part 1: General requirements (ISO 15223-1:2016, Corrected version 2017-03)

For more data, please see the following links:

• EU MDR Article 8 – Use of harmonized standards https://advisera.com/13485academy/mdr/use-of-harmonised-standards/
• What are EU harmonized standards? https://advisera.com/13485academy/blog/2020/06/12/what-are-eu-harmonized-standards/
• Link to the harmonized standards published by EU https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2020:090I:TOC