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Guest user Created:   May 07, 2021 Last commented:   May 13, 2021

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I would like to ask about the documents included with the "ISO 13485 & MDR Integrated Documentation Toolkit toolkit with expert support" 
We are a company with class I medical devices and are in the process of creating the SOPs to be compliant with MDR
Are your SOPs geared towards medical devices with higher classes (therefore more detailed and technical) or are they also suitable / can be modified for class 1 devices
For class 1 medical devices, we need to do SOPs for regulatory strategy; final product release; vigilance; and field safety corrective action. I don't seem to see those in the list of SOPs via the preview, and wanted to check if those are included or under a different name?

Also, does your company provide a way to identify in the SOPs which part of the relevant SOP is necessary for Class 1, and which parts are not? As we will likely only want to include the necessary info and not give extra unnecessary info.

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić May 10, 2021

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/

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Guest user May 10, 2021

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.

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Kristina Zvonar Brkić May 11, 2021

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:

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

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

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Tiffanie May 11, 2021

Under Article 10, a regulatory strategy SOP is required and for class 1 (self declared) devices, we are required to have this SOP by end of May 2021. 

I note your comment that this regulatory strategy SOP is not currently in your toolkit and is in development for June 2021. However as the deadline for companies to be compliant is May 2021, is it possible to share a draft version of the regulatory strategy SOP earlier / as soon as possible? I hope you understand the urgency of our request, as we understood that purchasing this toolkit meant we would have everything we needed in order to be compliant, however we are not able to be compliant with the MDR without a regulatory strategy SOP. Thanks!

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Kristina Zvonar Brkić May 13, 2021

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.

 

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