MDR Technical File Structure Requirements

s27bax

Starting to get Involved
#1
Hi,
Whilst searching for the best way to structure our technical files to MDR standard, I cam across a document from MDC which may be useful to share on here.

MDC have, for the most part, used An II and III as their basis but have added a few extra bits of detail.

I would be interested to get feedback from anyone who has put together an MDR tech file if the structure would work.

Has anyone else got any resources that they have come across when deciding how best to structure their tech files?

Thanks all
 

Attachments

Elsmar Forum Sponsor
J

Jnks_Meddev

#3
Why is everyone updating their Tech file summary format? We follow STED format and so I don't see why we need to change our summary to MDR format? Do we?
 
J

Jnks_Meddev

#5
Can you provide a sample. I am currently writing SOP for MDR tech file. I was going with STED format as it can be submitted both in EU, US etc but now I think it’s best to stick with MDR?
Also what would be the best generic way to approach tech file SOP?
 

Ronen E

Problem Solver
Staff member
Moderator
#6
You can stick with STED and once done verify against the MDR's text. If you're uncomfortable with the MDR's text you can check against BSI's guidance.

Devil's advocate: Why do you need a tech file SOP?
 

Philip B

Involved In Discussions
#7
You can stick with STED and once done verify against the MDR's text. If you're uncomfortable with the MDR's text you can check against BSI's guidance.

Devil's advocate: Why do you need a tech file SOP?
I agree, I don't think you should need a technical file SOP but there are always auditors who will insist on one and sometimes it is easier to comply than endlessly argue the case, as we discovered recently...
 

Ronen E

Problem Solver
Staff member
Moderator
#8
I agree, I don't think you should need a technical file SOP but there are always auditors who will insist on one and sometimes it is easier to comply than endlessly argue the case, as we discovered recently...
Did you try "Show me the Shall"...?

Personally I'd take the risk of a minor NC (BTW, a valid NC needs a requirement to be raised against) over burdening my system with lots of non-value-adding procedures set in place only to please potential mediocre auditors (who might end up not showing up after all). This is regulatory creep at its worst.

Added in edit: Industry developed this absurd notion that audit NCs (any level) are a disaster and must be avoided at all costs. NCs are at worst something you quickly fix and move on, and at best opportunities for improvement. This should be the nature and aspiration of any real QMS - to identify shortcomings and find better ways of doing things. The more the better.

Added in edit 2: I just realised that "The more the better" could sound wrong - I didn't mean "The more NCs the better" but rather "The more you find better ways of doing things, the better". Obviously the goal should be to always do your best initially and then hope for as few NCs as possible, but minimising NCs should never become the only / the ultimate goal. Definitely not at the cost of creating quality dead weight.
 
Last edited:
Thread starter Similar threads Forum Replies Date
Watchcat Anyone had an MDR technical file review/audit yet? EU Medical Device Regulations 13
N Technical file requirements class 1 device MDR Other Medical Device Regulations World-Wide 6
D MDD to MDR - Technical File conversion EU Medical Device Regulations 4
D Technical file structure/content requirements for Class IIa devices & new MDR EU Medical Device Regulations 14
R MDR & depth of technical files review by NB's EU Medical Device Regulations 18
P MDR/IVDR Annex III - Technical documentation on PMS EU Medical Device Regulations 1
D Hospital Decontamination and the MDR - Technical Files, UDI and PMS EU Medical Device Regulations 3
I Maintaining Technical Documentation under MDD and MDR EU Medical Device Regulations 1
C Access to Technical Documentation - MDR Chapter VI Article 61 EU Medical Device Regulations 4
N EU MDR Basic UDI-DI and Technical Documentation for Systems EU Medical Device Regulations 22
D MDR and Summary Technical Documentation Files EU Medical Device Regulations 18
A Can anyone share a Distribution Agreement template under MDR 2017/745? EU Medical Device Regulations 0
A MDR ANNEX XI part A or Part B EU Medical Device Regulations 0
N OBL under the MDR. Which are the obligations of the OEM? EU Medical Device Regulations 0
U Distributor obligations under MDR EU Medical Device Regulations 1
Raisin picker CECP, consultation according to Art 54 MDR EU Medical Device Regulations 1
K Question on MDR classification EU Medical Device Regulations 4
M STED vs MDR EU Medical Device Regulations 0
F UDI-PI required on packaging (MDR) EU Medical Device Regulations 2
M Extension to shelf life of new product under MDR EU Medical Device Regulations 1
J Instructions for use for Class I devices under MDR EU Medical Device Regulations 1
K Importer in EU, but not distribute in the EU - MDR obligations EU Medical Device Regulations 0
K MDR Class 1 Self Certification - Competent Authority or Notified Body? EU Medical Device Regulations 6
M Responsibilities of Importers / Distributors - MDR EU Medical Device Regulations 3
S PSUR - MDR First Submission Requirement? EU Medical Device Regulations 2
R EU-MDR Article 9-common specifications Other ISO and International Standards and European Regulations 2
JoCam Certified QMS for MDR - Class I medical device manufacturers EU Medical Device Regulations 4
JoCam MDR Gap Analysis - Consultant fees EU Medical Device Regulations 10
N Is there a need for clinical test of Class IIa products (for MDR)? EU Medical Device Regulations 2
M Examples of Combination Products - MDR Article 1 (8) and MDR Article 1(9) Medical Device and FDA Regulations and Standards News 3
P EU MDR Translation of Product Name EU Medical Device Regulations 0
N Is this a single integral drug device combination product EU MDR CE Marking (Conformité Européene) / CB Scheme 1
R Components to a finished medical device, MDR requirements Other US Medical Device Regulations 1
K Quality Agreement MDR - The manufacturer is outside of EU Other Medical Device Related Standards 4
M MDR - eIFU - When you can supply an electronic IFU instead of a paper IFU EU Medical Device Regulations 5
M MDR harmonized standards EU Medical Device Regulations 3
cscalise RAPS/Med Dev EU MDR Guidebook - Reviews or Opinions? EU Medical Device Regulations 0
V New Product Model CE Mark Certification under MDR EU Medical Device Regulations 0
E MDR PRRC "jointly responsible" EU Medical Device Regulations 1
J Strategy for MDR Regulatory Compliance Procedure ISO 13485:2016 - Medical Device Quality Management Systems 4
S EU MDR Annex I Chapter III 23.4 z EU Medical Device Regulations 2
U EU-MDR: Complicated supply chain EU Medical Device Regulations 4
C EU MDR - Annex II 6.1 Pre-clinical and clinical data EU Medical Device Regulations 4
A IVD in MDR procedure pack EU Medical Device Regulations 2
Ed Panek IFU Contact Requirements - FDA and MDD/MDR US Food and Drug Administration (FDA) 1
S Are EC type examinations still being conducted under MDR? EU Medical Device Regulations 5
U MDD Article 12/ MDr Article 22 interpretation EU Medical Device Regulations 2
E MDR internal audit Internal Auditing 1
R The term "Benefit Risk Ratio" in EU MDR, do I need to present benefit risk analysis as a RATIO Risk Management Principles and Generic Guidelines 4
R MDR, Annex I, 23.1 Interpretation - IFU on the website EU Medical Device Regulations 5

Similar threads

Top Bottom