Differences between medical device certifications and ISO 13485

Medical device certification is a process where you will get the CE mark and you can sell your product on the EU market. This means that you need to prepare technical documentation that is requested in the Medical device directive 93/42/EEC (unitl May 2021) or in Medical device regulation 2017/745 – Annex 2 (from May 2021). 

ISO 13485:2016 is a standard for quality management systems. It means that you need to prepare your processes and documentation to prove that it is under control and fulfill all applicable requirements from the standard. On the EU market, 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 the 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/
• EU MDR Annex 2 - https://advisera.com/13485academy/mdr/technical-documentation/
• 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
• 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/
• How to determine regulatory requirements according to ISO 13485:2016 https://advisera.com/13485academy/knowledgebase/how-to-determine-regulatory-requirements-according-to-iso-13485/
• Checklist of ISO 13485 implementation and certification steps https://advisera.com/13485academy/knowledgebase/checklist-of-iso-13485-implementation-and-certification-steps/