We are entering the market of medical devices - To start with IR Thermometer. 1. Is 13485 Mandatory or ISO 9001 With the scope covering IR Thermometer enough? 2. Is 13485 Certification mandatory to obtain the CE Mark?
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.
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: