Toolkit content

Our documentation is designed to suit every type of medical device, regardless of class. It is then up to the manufacturer to adjust the documentation, that is, to amend or delete individual paragraphs if necessary.

The final product release is covered in the procedure for production, vigilance, and field safety corrective action is covered in the Procedure for Adverse Event Investigation and Reporting. The procedure for regulatory strategy is currently in development and will be issued in June 2021.

For class I, you also need procedure for Post-market surveillance so please look at the following link: https://advisera.com/13485academy/iso-13485-eu-mdr-documentation-toolkit/

Thank you for your helpful reply on the Expert Advice Community.

Based on your responses and my understanding, it seems that for class 1 (self-declared) medical devices, the mandatory / required QMS documents within your toolkit are:

• 01 quality manual
• 11 production and service provision (covers final product release)
• 16 Adverse Event Investigation (covers vigilance, and field safety corrective action)
• 18 post-market surveillance
• 06 risk management 
• 19 clinical evaluation 

And that there is one QMS SOP that's required that's not within your toolkit: being regulatory strategy SOP.

Could you kindly confirm that my understanding is correct? And that we do not need to complete any of the other documents within your toolkit for QMS documentation for class 1 (self-declared) medical devices?

Thank you again very much for your help.

You are partly right. 

Every manufacturer of medical devices, if it wants to comply with MDR, must have a quality system implemented (Article 10 – General obligations of manufacturers). The ISO standard that is directly related to the quality system for medical device manufacturers is ISO 13485: 2016. All documents from our toolkit cover all requirements from ISO 13485: 2016. Of course, if you do not have sterilization, then you will remove documents related to sterilization from the toolkit. If you do not have implemented products, then you will remove some sections from the production and service provision procedure that relate to the traceability of embedded products. However, all other documentation is required.

In addition, each medical device must have Technical Documentation prepared in accordance with Annex 2.

For more information, see:

• EU MDR Article 10 - General obligations of manufacturers https://advisera.com/13485academy/mdr/general-obligations-of-manufacturers/
• EU MDR Annex 2 – Technical documentation https://advisera.com/13485academy/mdr/technical-documentation/

We are also providing free webinars. The next one that considers the implementation steps of the ISO 13485 is scheduled for 29.06.2021.:

• A how-to guide for ISO 13485 implementation https://advisera.com/13485academy/webinar/a-how-to-guide-for-iso-13485-implementation-free-webinar/

More information about the ISO 13485, you can find on the following links:

• What is ISO 13485? https://advisera.com/13485academy/what-is-iso-13485/
• Six key benefits of ISO 13485 implementation https://advisera.com/13485academy/knowledgebase/six-key-benefits-of-iso-13485-implementation/
• How can ISO 13485 help with MDR compliance? https://advisera.com/13485academy/blog/2020/03/09/how-can-iso-13485-help-with-mdr-compliance/
• How to get ISO 13485 certified? https://advisera.com/13485academy/iso-13485-certification/

I do understand the urgency, however, but nothing will happen if you will receive it later in June. I have to check with my colleagues is it possible to send you a draft version.