Is 13485 Mandatory for making IR Thermometer?

1. Is 13485 Mandatory or ISO 9001 With the scope covering IR Thermometer enough?

All medical devices must be in compliance with harmonized standards. In MDR, in Article 10 General obligations of manufacturers, it is stated that the manufacturer must have implemented a quality management system. The list of harmonized standards is published by Official Jurnal of the European Union. On this list, ISO 13485:2016 is the only standard covering quality management system, therefore it is expected for manufacturers to have implemented ISO 13485:2016.

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/
• EU MDR Article 10 – General obligations of manufacturers https://advisera.com/13485academy/mdr/general-obligations-of-manufacturers/
• 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

2. Is 13485 Certification mandatory to obtain the CE Mark?

No, neither in MDD (93/42/EEC) nor MDR (2017/7450), there is no direct requirement that manufacturers need to be certified according to the ISO 13485:2016. The requirement is only to have implemented a quality management system as is explained in the previous answer.

If you need any help for the implementation of the ISO 13485:2016, these materials can help:

• What is ISO 13485? - https://advisera.com/13485academy/what-is-iso-13485/
• Checklist of ISO 13485 implementation and certification steps - https://advisera.com/13485academy/knowledgebase/checklist-of-iso-13485-implementation-and-certification-steps/
• Six key benefits of ISO 13485 implementation - https://advisera.com/13485academy/knowledgebase/six-key-benefits-of-iso-13485-implementation/

You can see our ISO 13485:2016 Documentation toolkit on the following link: https://advisera.com/13485academy/iso-13485-documentation-toolkit/