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.

Rework is covered in the 15_Procedure_for_Control_of_Non_Conforming_Products_Premium_EN in section 3.4 Handling non-conforming product. 

For more information on how to handle non-conforming products, please see the following article:

• How to comply with ISO 13485:2016 requirements for handling complaints https://advisera.com/13485academy/blog/2017/03/21/how-to-comply-with-iso-134852016-requirements-for-handling-complaints/

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.

All requirements and topics that are covered in the folder Clinical evaluation is necessary for manufacturers of class I medical devices. So you need to make literature research about your product, make an equivalence with an existing product on the market, and make a report as described in annexes 1, 2, 3, and 4. 

More information on the clinical evaluation you can find in the following articles in the MDR:

• EU MDR Article 61 – Clinical evaluation https://advisera.com/13485academy/mdr/clinical-evaluation/
• EU MDR Annex 14 – Clinical evaluation and post-market clinical follow-up https://advisera.com/13485academy/mdr/clinical-evaluation-and-post-market-clinical-follow-up/

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

If your medical device is Class I, then it does not require the involvement of the notify body. In that case, you need to prepare the Self-declaration of conformity and technical file according to the Annex II Technical documentation and Annex III Technical documentation on Post-market surveillance. However, you need to contact the notify body in regards to the certification of ISO 13485:2016.

Which elements must be in the Declaration of conformity, you can find in Annex 4 – EU Declaration of conformity.

For more information, see:

• EU MDR Annex II – Technical documentation https://advisera.com/13485academy/mdr/technical-documentation/
• EU MDR Annex III – Technical documentation on Post-market surveillance https://advisera.com/13485academy/mdr/technical-documentation-on-post-market-surveillance/
• EU MDR Annex 4 – EU declaration of conformity https://advisera.com/13485academy/mdr/eu-declaration-of-conformity-2/