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MDR and Summary Technical Documentation Files
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MDR and Summary Technical Documentation Files
MDR and Summary Technical Documentation Files
MDR and Summary Technical Documentation Files
MDR and Summary Technical Documentation Files
MDR and Summary Technical Documentation Files
MDR and Summary Technical Documentation Files
MDR and Summary Technical Documentation Files
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MDR and Summary Technical Documentation Files


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Some Related Topic Tags
mdr (medical device regulations), sted (summary technical documents)
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  Post Number #1  
Old 17th April 2018, 08:56 AM
Device1000

 
 
Total Posts: 2
Question MDR and Summary Technical Documentation Files

Hello, I am interested in hearing your approach and ideas to transition a Summary Technical Documentation File from compliance with the EU medical device directive to the medical device regulation.

Our NB will be reviewing the STED file 2019 as part of the annual MDD surveillance, and then very soon after reviewing the STED file for MDR certification. Therefore, rather than have 2 separate STED files for the device (1 for MDD compliance and 1 for MDR compliance) I would like 1 STED file that covers both, and begin to start preparing it now. For example, it would contain both an Essential Requirements Checklist and a General Safety and Performance Requirements Checklist.

Has anyone else considered this approach/discussed with their NB? What did you decide to do?!

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  Post Number #2  
Old 17th April 2018, 04:56 PM
Mark Meer

 
 
Total Posts: 749
Re: MDR and Summary Technical Documentation Files

In order to avoid redundant/duplicate documentation, our device "technical file" is a mixed bag that goes beyond just EU requirements, be it MDD or MDR.

As discussed in this thread, there is already a lot of overlap between the requirements of ISO13485, US FDA DMR, and EU technical file. Why not just have a set of documents that fulfil all these requirements (MDD & MDR included), with no redundancies?

I admit this is still on my TODO, but briefly/generally, the plan for our device files (technical files) is to organise them as follows:

1. Part A - Summary: Basic info about the device: intended use, technologies, manufacturing facilities, regulatory certifications, materials, components, labelling...

2. Part B - Documentation: A list of references to all the relevant design and production documentation, including specifications, risk files, design drawings, schematics, test reports, production work-instructions...

3. Annexes: Checklists for specific regional regulatory requirements. Example:
Annex A: European Essential Requirements Checklist
- A1: MDR Checklist
- A2: Legacy MDD 93/42/EEC Deviations Checklist
Annex B: Canadian CMDR Requirements Checklist
Annex C: China Basic Requirements for Safety and Effectiveness Checklist
...

Sure, some NB auditors may not appreciate all the extra (non-EU-related) information/sections lumped together...but as long as all the required info they're looking for is there (and you can quickly retrieve it for them), this approach will certainly eliminate a bunch of redundancies.
Thank You to Mark Meer for your informative Post and/or Attachment!
  Post Number #3  
Old 19th April 2018, 04:45 AM
Device1000

 
 
Total Posts: 2
Re: MDR and Summary Technical Documentation Files

Thank you. This is very helpful, and has got me thinking about 'global' STEDs if we expand out of Europe!
  Post Number #4  
Old 19th April 2018, 07:09 AM
Gamula's Avatar
Gamula

 
 
Total Posts: 24
Truce Re: MDR and Summary Technical Documentation Files

Hi, we are facing the same bipartite situation with our documentation - mostly class IIa / IIb dental devices - and we have done the following:

All technical documentation, which is in FDA style with DMR + DHF - will be written new in the STED file format.

The clinical evaluations - as we try to avoid clinical investigation by means of clinical trials - will be also written new and we are fullfilling the MDR 2017/745 and MEDDEV 2.7/1 (Rev.4). Additionally, the we add the registration information from other countries - like STED recommends - but just as an add on.

Last but not least, the usability, which is not in depth mentioned for the MDR technical documnetation and STED, an additional add on to the STED and cinical evaluation (of course for the risk mgmt).

Just to say in short: You can try to implement all in the files but you need time and man power.

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