IMDRF or still GHTF for STED and other guidance?

#1
Since July of this year I am working for a Dutch company that produces dental- and CMF-implants. Before that I worked for an IVD-manufacturer.
In both companies part of my duties is the registration/notification of the manufactured devices with competent authorities. As a result I now have to start a product-registration procedure suitable for a notification compliant to the EU's MDR.
For my previous work I used the GHTF STED-documenation to set up the registration file. Because I now work on medical devices I went to the IMDRF-site for medical device STED-guidance documentation. There I discovered that IMDRF has documentation, dated March 2019, that seem to be the follow up of the GHTF-STED.
A search for STED only leads to GHTF documents of which the latest STED for medical devices is a proposed document from 5 March 2007. The most current accepted GHTF-version is from 25 October 2002. Are the 2002 GHTF-documents still the current official version or have they become defunct as result of the new IMDRF-documentation, and are the IMDRF-versions now the official version?

It is very confusing to me.

Can someone inform me on:
- what documenation to use, GHTF or IMDRF?
- if IMDRF then which documents?

Thank you very much in advance for your help.
 
Elsmar Forum Sponsor

Marcelo

Inactive Registered Visitor
#2
Use the IMDRF TOC from the Regulated Product Submission action item in principle. I don't like some of the things the TOC has (for example, including full reports in the body instead of on the Annex), but this will be used I the future. Anyway, I suggest still using the concepts from the GHTF documents too.
 
#3
Thank you very much for the quick response Marcelo.
Combining IMDRF and GHTF makes it difficult, especially since the most recent GHTF-version (SG1(PD)/N011R20) is a proposed revised document, and not a final version. That revised version has far more elements though, and in doing so has much more compatibility to the MDR-requirements.
Which one to use as the main guide document for a registration file, GHTF or IMDRF?

- [SG1/N011R17] GHTF SG1 - Principles of Safety and Performance of Medical Devices (STED) - 25 October 2002:
###.imdrf.org/docs/ghtf/archived/sg1/technical-docs/ghtf-sg1-n011r17-conformity-to-safety-principles-medical-devices-021025.doc
- [SG1(PD)/N011R20] GHTF SG1 Essential Principles of Safety and Performance of Medical Devices (STED) - 5 March 2007:
###.imdrf.org/docs/ghtf/archived/sg1/technical-docs/ghtf-sg1-n011r20-essential-principles-safety-performance-medical-devices-sted.doc
 
Last edited:

Marcelo

Inactive Registered Visitor
#4
Hu, sorry, I did not suggest formally combining, only using the GHTF docs because the concepts are still the same. In fact, the TOC is an "evolution"of the old STED format.

I also combine different documents which I think give best solutions, for example, in the case of what to write in each topic, I use as a basis the FDA guidance on Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions.

It's also very important to include, in each topic, a discussion on why what you did fulfills which specific regulatory requirement you want to show conformity with .

The essential principles to be used really depends on the country-regulatory system you want to apply to.
 
#5
Once again many thanks for the quick response.
I'll discuss your information with my colleague. I'm certain we will return with further questions (and gladly make use of the offer formulated in the red footers of your replies). For now we are going to try to organise the requirements from the various IMDRF/GHTF documents.
 
Thread starter Similar threads Forum Replies Date
M Informational TGA-led IMDRF Personalised Medical Devices working group meets in Canberra Medical Device and FDA Regulations and Standards News 0
M Informational IMDRF draft document – Principles and Practices for Medical Device Cybersecurity Medical Device and FDA Regulations and Standards News 0
M Informational IMDRF draft document – Requirements for Regulatory Authority Recognition of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews Medical Device and FDA Regulations and Standards News 0
M Informational IMDRF proposed document – IMDRF terminologies for categorized Adverse Event Reporting (AER): terms, terminology structure and codes (Edition 4) – Anne Medical Device and FDA Regulations and Standards News 0
J MEDDEV 2.12/1's new MIR & IMDRF terms & codes (IMDRF Annex) EU Medical Device Regulations 1
M Informational IMDRF Consultation – Personalized Medical Devices – Regulatory Pathways Medical Device and FDA Regulations and Standards News 0
M Informational IMDRF – Proposed update to Clinical Evaluation documents Medical Device and FDA Regulations and Standards News 0
M Informational CDRH Proposes New IMDRF Work Item on Standards Medical Device and FDA Regulations and Standards News 0
M Informational IMDRF final document – Assembly and Technical Guide for IMDRF Table of Contents Submissions Medical Device and FDA Regulations and Standards News 4
M Medical Device News IMDRF update - 26-09-18 - Cybersecurity, Premarket Reviews, Personalized Devices Other Medical Device Regulations World-Wide 0
F IMDRF opened a Consultation on Annex E & F and the link to ISO 14971 ISO 14971 - Medical Device Risk Management 4
T MEDDEV 2.7/1 r4 vs. IMDRF/SaMD WG/N41 Other Medical Device Related Standards 3
H GHTF and IMDRF - Alternative for the STED format EU Medical Device Regulations 5
SteveK NB-MED, NBOG, IMDRF and MEDDEV hierarchy EU Medical Device Regulations 3
M IMDRF document - Application of QMS to SaMD ISO 13485:2016 - Medical Device Quality Management Systems 2
W IEC 62304 vs. IMDRF SaMD Guideline Risk Class IEC 62304 - Medical Device Software Life Cycle Processes 5
P IMDRF (International Medical Devices Regulators Forum)guidance on standalone software Medical Information Technology, Medical Software and Health Informatics 1
AnaMariaVR2 IMDRF Working With ICH on Harmonized Electronic Submission System for Drugs, Devices Other Medical Device Regulations World-Wide 0
Ajit Basrur IMDRF inviting comments on Audit Program and UDI ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 0
Ronen E IMDRF Feb/Mar 2012 Meeting - Outcome Statement Other Medical Device Regulations World-Wide 9
Ajit Basrur GHTF evolves into International Medical Device Regulators' Forum (IMDRF) Other Medical Device Regulations World-Wide 0
N What is our product classification? (Does Unclassified classification still exists) Other US Medical Device Regulations 14
C Document Control Stamps - Does anyone still stamp their documents? Document Control Systems, Procedures, Forms and Templates 24
E Can we still use MEDDEV 2.4/1 rev. 9 when classifying a medical device product under MDR? EU Medical Device Regulations 4
H Can a calibration lab still use ISO 6789:2003 as guide for torque calibrations Other ISO and International Standards and European Regulations 1
Z Do we still have to put UDI if we have DI and lot number seperately on our product ? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
S Can we still manufacture whilst awaiting return of our CE Mark? Other Medical Device Related Standards 1
R FDA - How to discontinue/obsolete medical devices that share sub-components with others that will still be distributed Other US Medical Device Regulations 5
M CEP requirements in MEDDEV 2.7/1, rev 4 and MDR - Are all MEDDEV requirements still applicable? EU Medical Device Regulations 7
M We still have not received our certificate due to a 'backlog' with our auditing body Registrars and Notified Bodies 25
L 510k exemption process - Do you still need to submit technical dossier? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
Sidney Vianna IATF 16949:2016 still doesn't get 7.1.4 of ISO 9001:2015 IATF 16949 - Automotive Quality Systems Standard 15
A Can change control can be closed if the CAPA is still open? Nonconformance and Corrective Action 3
M Are ASTM F745 & ASTM F75 still valid? EU Medical Device Regulations 5
R Still confused on OPRP and CCP in an ISO 22000 Catering Business Food Safety - ISO 22000, HACCP (21 CFR 120) 3
J ISO 9001:2008 - Can I still conduct Internal Audits in my company? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Wes Bucey Another year - still happy! Covegratulations 5
Marc The "Reading Room" forum is still here The Reading Room 5
T ISO13485 cert expired - Product still CE Marked CE Marking (Conformité Européene) / CB Scheme 1
J Can a Surge test fail to a test level and still considered as Compliant? IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
T Predicate device recalled - Still a valid predicate device? Other US Medical Device Regulations 7
M Is calibration from long ago still valid on never used pipettes? General Measurement Device and Calibration Topics 8
Q Can a fail still be a pass? (Criteria Level B for 61000-4-6 Conducted Immunity) IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
B Are the GHTF guidance documents still relevant? ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 5
quality1 Form IPC 1720A Assembly Qualification Profile still required? Various Other Specifications, Standards, and related Requirements 1
R Is EN/IEC 60417 still current? Other Medical Device Related Standards 4
M Is a Management Representative still needed for ISO 13485:2015? ISO 13485:2016 - Medical Device Quality Management Systems 7
Y Consultation: EN 980 still recognized by EU regulation? EU Medical Device Regulations 4
x-files Plans/Requests from Parent Company: Objectives or still plans? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A CE Certificate is valid until 3.12.2013 - Can I still sell the products in Europe? EU Medical Device Regulations 10
Similar threads


















































Top Bottom