MDR and Summary Technical Documentation Files

D

Device1000

#1
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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Mark Meer

Trusted Information Resource
#2
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.
 
D

Device1000

#3
Thank you. This is very helpful, and has got me thinking about 'global' STEDs if we expand out of Europe!
 

Gamula

Involved In Discussions
#4
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.

:magic:
 

Wolf.K

Quite Involved in Discussions
#5
Is it good or bad that there are so many different regulatory requirements, depending on the country you want to market your device? I mean, we in quality and regulatory have always a lot to do and will not become unemployed soon... But on a global perspective, with a risk-based thinking approach in mind, I think all these different regulations pose a threat to the patients! It is about time that we get a single regulation worldwide!!!
 

Mark Meer

Trusted Information Resource
#6
...
It is about time that we get a single regulation worldwide!!!
Agree in principle, disagree in practice.

There is currently a big push for a global regulatory framework, and I think most people advocating this - like yourself - have the best intentions. However, what I see being the most likely outcome is that you end up with some behemoth bureaucracy, and stifling regulations.

This is because every interested party wants a say. If you are a country who currently has strict regulations, do you think you'd be ok accepting a global system that was less strict? No! ...so any global regulation would necessarily tend towards the most strict.
 

Wolf.K

Quite Involved in Discussions
#7
Yes, but even a very strict regulation is better then trying to fulfill all the regulations of USA, EU, Brazil, Canada, India, Japan, Taiwan, Korea, China, Australia and After-Brexit-UK, if you are just one person responsible for all this paper work!
 

Sam Lazzara

Trusted Information Resource
#8
In March 2018, IMDRF published 2 guidance documents related to the "Global" Table of Contents (ToC) for market authorization submissions.

IMDRF/RPS WG/N13 FINAL 2018 In Vitro Diagnostic Device Market Authorization Table of Contents (IVD MA ToC)

IMDRF/RPS WG/N9 FINAL 2018 Non-In Vitro Diagnostic Device Market Authorization Table of Contents (nIVD MA ToC)

Here is a link to the IMDRF Documents page where you can find them.
 
Last edited:

Rincewind

Involved In Discussions
#9
Is it save to assume that this structure will become the new structure for the technical documentation expected by NBs and would it be a good idea to start structuring our technical documentation according to this document?
 
#10
Hi All -

Has the EU posted their proposed Classification Matrices to describe the relevant elements of these IMDRF ToCs, as applied to 2017/745 MDR Technical Documentation requirements?

FDA has posted their Classification Matrices in November 2017.

Thanks!
:thanx:
 
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