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Fi nal doc ument s
IMDRF/RPS
WG/N13FINAL:2014
In Vitro Diagnostic Medical
Device Market Authorization
Table of Contents (IVD MA ToC)
- PDF (650kb)
In Vitro Diagnostic Medical
Device Market Authorization
Table of Contents (IVD MA ToC)
- DOCX (288kb)
14 August
2014
50
IMDRF/RPS
WG/N9FINAL:2014
Non-In Vitro Diagnostic Device
Market Authorization Table of
Contents (nlVD MA ToC) - PDF
(650kb)
Non-In Vitro Diagnostic Device
Market Authorization Table of
Contents (nlVD MA ToC) -
DOCX (288kb)
14 August
2014
49
IMDRF/WG/N3FINAL:2013 Requirements for Medical
Device Auditing Organizations
for Regulatory Authority
Recognition - PDF (553kb)
Requirements for Medical
Device Auditing Organizations
for Regulatory Authority
Recognition - DOCX (129kb)
18 December
2013
24
IMDRF/WG/N4FINAL:2013 Competence and Training
Requirements for Auditing
Organizations - PDF (558kb)
Competence and Training
Requirements for Auditing
Organizations - DOC (239kb)
18 December
2013
22

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Documents
http://www.imdrf.org/documents/documents.asp[2014-08-20 11:09:14]
IMDRF/WG/N5Final:2013 Regulatory Authority
Assessment Method for the
Recognition and Monitoring of
Medical Device Auditing
Organizations - PDF (550kb)
Regulatory Authority
Assessment Method for the
Recognition and Monitoring of
Medical Device Auditing
Organizations - DOC (639kb)
18 December
2013
32
IMDRF/WG/N6FINAL:2013 Regulatory Authority Assessor
Competence and Training
Requirements - PDF (525kb)
Regulatory Authority Assessor
Competence and Training
Requirements - DOCX (119kb)
18 December
2013
18
IMDRF/WG/N7FINAL:2013 UDI Guidance: Unique Device
Identification (UDI) of Medical
Devices - PDF (951kb)
UDI Guidance: Unique Device
Identification (UDI) of Medical
Devices - DOCX (129kb)
18 December
2013
19
IMDRF/WG/N10FINAL:2013 Software as a Medical Device
(SaMD): Key Definitions - PDF
(502kb)
Software as a Medical Device
(SaMD): Key Definitions - DOCX
(68kb)
18 December
2013
9
Pr oc edur al doc ument s
IMDRF/MC/N16FINAL:2014 IMDRF Document Format and
Style Guide - PDF (75kb)
IMDRF Document Format and
Style Guide - DOCX (79kb)
23 April 2014 14
IMDRF/MC/N17FINAL:2014 IMDRF Document Template -
DOCX (44kb)
23 April 2014 6
IMDRF/MC/N18FINAL:2014 IMDRF Presentation Template -
PPT (116kb)
23 April 2014 3
IMDRF/MC/N2FINAL:2013 IMDRF Standard Operating
Procedure - PDF (319kb)
IMDRF Standard Operating
Procedure - DOCX (83kb)
17 December
2013
21
IMDRF/MC/N1FINAL:2013 IMDRF Terms of Reference -
PDF (67kb)
IMDRF Terms of Reference -
DOC (101kb)
18 November
2013
9
Documents
http://www.imdrf.org/documents/documents.asp[2014-08-20 11:09:14]
I nf or mat i on doc ument s
IMDRF/RPS
WG/N21FINAL:2014
RPS Beta Testing Document -
PDF (1.2Mb)
16 May 2014 145
Out c ome st at ement s
N/A San Fransisco meeting outcome
statement - PDF (33kb)
San Fransisco meeting outcome
statement - DOCX (64kb)
27 March
2014
3
N/A Belgium meeting outcome
statement - PDF (31kb)
Belgium meeting outcome
statement - DOC (76kb)
12 November
2013
2
N/A France meeting outcome
statement - PDF (60kb)
France meeting outcome
statement - DOC (159kb)
19 March
2013
2
N/A IMDRF Chair and Secretariat
rotates to Europe - PDF (35kb)
IMDRF Chair and Secretariat
rotates to Europe - DOCX
(25kb)
21 J anuary
2013
1
N/A Sydney meeting outcome
statement - PDF (63kb)
Sydney meeting outcome
statement - DOC (160kb)
25
September
2012
2
N/A Singapore meeting outcome
statement - PDF (56kb)
Singapore meeting outcome
statement - DOC (58kb)
28 Feburary
2012
2
N/A Media statement - Successful
Launch to the IMDRF - PDF
(41kb)
Media statement - Successful
Launch to the IMDRF - DOC
(29kb)
28 March
2012
1
For a list of IMDRF meeting minutes and outcome statements, see the Meetings page.
For a list of IMDRF proposed documents, see the Consultations page.
GHTF final documents
These documents were created by the Global Harmonization Task force (GHTF). These are
final documents and are still current. As the work of IMDRF progresses, these documents will
be reviewed and published as IMDRF documents. Until that time, these documents are provided
for the use of interested parties. If you become aware that any of these documents are out of
date, please advise the IMDRF Secretariat so that a review can be scheduled on the IMDRF
Documents
http://www.imdrf.org/documents/documents.asp[2014-08-20 11:09:14]
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