I attended the Webinar “Overview of steps needed to comply with EU MDR”
Who needs to get certified: included Manufacturer of Class 1 medical devices. What do you mean by certifying? Does it mean to get certified by ISO 13485:2016?
To be honest I have studied the complete EU MDR. By attending your Seminars and Q/A sessions. I understand the Medicine Product Class 1 does not need the Certificate from Notified bodies according to ISO 13485.
We just need to prepare our QMS according to ISO 13485 and EU MDR.
If I am understanding it wrong please guide me accordingly.