EU medical device regulation

From the EU point of view, you do not need to be certified according to the ISO 13485. However, the FDA has in 2018. decide to harmonize and modernize the Quality System Regulations (QSR) under 21 CFR Part 820 to more closely align with the international ISO 13485:2016. This decision was due to the fact that ISO 13485 quality standard forms the basis for quality management system requirements in the European Union, Japan, Canada, and other medical device markets. The latest information that is published is that the FDA plans to issue a notice of proposed rulemaking in October 2020. 

So, please check regularly FDA page because the final answer is expected at any moment. 

In the meantime, the following articles can be useful:

• What is ISO 13485? https://advisera.com/13485academy/what-is-iso-13485/
• How to get ISO 13485 certified? https://advisera.com/13485academy/iso-13485-certification/
• 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/

If you will need any other assistance with ISO 13485:2016 assistance, please do not hesitate to contact us.