ISO 13485 & EU MDR - Expert Advice Community

Relation ISO, MDR and CE

For initial research I am wondering how CE marking, Medical Devices Regulation 2017/745, ISO 14971 and ISO 13485 are related to each other?

Rework procedure and Clinical evaluation for media mfg

1. Is there a rework procedure in the tool kit?  I did not see it in there and I believe it is an ISO requirement for clause 8.3.4.  Thank you.
2. I have a question about the clinical evaluation requirement.  What exactly is needed for media manufacturer class 1 medical device?

In looking at the documents in the toolkit it I am not sure if it applies.

3. Also when is a CE mark required?  How do I apply for a UDI # since we don’t currently have one?

Is ISO 13485 required by MDR?

This document (https://info.advisera.com/13485academy/free-download/8-step-transition-process-from-mdd-to-mdr/) states that ISO 13485 is required by the MDR? I understand that a QMS is required but the MDR does not specify ISO 13485?

What is perceived as a risk from production control?

What is perceived as a risk from production control? When risk causing incidences are forecasted as 1 in 1000 for Class IIa devices which are in market for several decdes, stretching into risk in production control is not understandable.

Is the Technical File still a requirement?

Is the Technical File still a requirement? I do not see any mention to this in the updated ISO 13485

ISO 9001 and ISO 13485 PMS

Hi we are aiming at obtaining iso 13485 and 9001. Only one part of our complete product is MD1 ()medical device class 1.) so majority of product will fall under 9001 and minor part under 13485. However. When performing PMS/PSUR- do we need to perform it on the complete product or only on the part that is medical device?

ISO 13485 and cleaning process

I need what ISO 13485 says about cleaning process.

MDD to MDR Transition

My company recently had an MDD Tech File audit come from our notified body with 4 major and 3 minor nonconformities. Our CE Mark expires April 17, 2021. Can we move to another notified body and work with them on getting our CE Mark under MDR rather than clearing nonconformities with the first notified body. We understand our CE Mark will be under suspension until we comply with MDR.

Using certified contract manufacturer impact

We are set to produce our medical device through a contract manufacturer who holds ISO 13485 and ISO 9001 certifications. How does our use of a certified contract manufacturer impact what is required of our company regarding MDR / CE Mark? 

ISO 13485 documentation question

 if we are only a distributor but may have to register products in the future would be these be the files that we would need