EN ISO 13485 - Medical devices - Quality management systems - Requirements for regulatory purposes

EN ISO 13485:2016 is an essential European standard (and international standard) for the Medical Devices and In Vitro Diagnostics Medical Devices industries as it specifies requirements for a quality management system for organisations to be able to demonstrate they can provide medical devices and related services consistently meeting customer and applicable regulatory requirements.

Such organizations providing medical devices and related services can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). The standard can also be used by suppliers or external parties that provide products, including quality management system-related services to such organizations.

This standard (EN ISO 13485:2016 together with the European Amendment EN ISO 13485:2016/A11:2021) supports the application of the two European Regulations on Medical Devices (MDR) and on In Vitro Diagnostics Medical Devices (IVDMDR)

• 2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC - Click to check the Summary of references to Harmonised standards supporting the MDR as of February 2022
• 2017/746 - Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU - Click to check the Summary of references to Harmonised standards supporting the IVDMDR as of February 2022