ISO commenting template/Report of voting
1MBClause /subclause(e. g. 3.1)

Paragraph/
Figure/Table(e. g.
Table 1)

Typeofcom2ment(e. g.
ed)

Date : 2001-11-05

Comments: Justification for change

Document: DIS 14155-1

Proposed change① Delete “For undated references,the latest edition of the normative
document referred to applies.
Members of ISO and IEC maintainregistersofcurrently
validInternational Standards”.
② Add as Annex A (normative)“WorldMedicalAssociation
DeclarationofHelsinkiguiding
The ICH GCP Guideline refers to the 1996 Recommendations
physiciansbiomedicalresearch
edition of the Helsinki Declaration.
involving human subjects” (edition ofOctober 1996)③ Delete the footnote 1)

JISC

2

4th to 6thlines

ge

Rationale / Comment :It is not reasonable to make all subsequent
amendments or revisions of the other
International Standards automatically beapplied to ISO 14155. The member of ISO
TC194 or CEN258 may not have any
authority to review or comment the other
International Standards.

JISC

3.14

2nd NOTE

teDelete “NOTEThis definition
Rationale / Comment :includesanyresponsethat is a result“User error” is not included in the definition
ofausererror”.
of “adverse device effect” according to theGHTF(Global Harmonization Task Force).

JISC

4

1st NOTE

geRationale / Comment :We do not have the literature review routeas a way of the regulatory registration ofthe medical device. It should be clarified
that the Guidance is applied only to thespecific cases.

Proposed Changes / Comment : (Addthe underlined language.)
NOTE Guidance is given in annex A.
It shall be applied to the case which
does not require the well-designed
clinical investigation.

JISC5.1

ge

Rationale / Comment :Propose Changes :1
2

Observations of the secretariat
on each comment submitted

MB = Member body (Enter two-letter country code, e. g. CN for China)
Type of comment: ge = generalte = technicaled = editorial

NB Columns 1, 2, 4, 5 are compulsory
page 1

FORM 13B (ISO) 2001-07-01

ISO commenting template/Report of voting
1

MB

Clause /subclause(e. g. 3.1)

Paragraph/Figure/Table(e. g.
Table 1)

Typeofcom2ment(e. g.
ed)Date : 2001-11-05

Comments: Justification for change

Proposed changeThe same reason as we explained in 2 Delete“andNormative references.
amendments”.

JISC

6.7.4

JISC

6.7.5

JISC

6.13

JISC

8.212iv)

teDocument: DIS 14155-1

its

Observations of the secretariat
on each comment submitted

subsequent

Rationale / comment :Proposed Changes : (Change to)

To clarify the sentence.

iv) statement on possible consequences ofwithdrawal to the subject or othersteRationale / Comment :Proposed Changes :We consider that these are the explanation (1) Change the state of 6.7.5 fromof 6.7.4., not requirementclause to NOTE.

1st linete

Rationale / Comment :Proposed Changes : (Change to)This clause should be consistent with 11.2 A final report shall always be
which has already been modified.
presented in written form. This shallbe signed by the sponsor and theprincipal clinical investigator(s) andthe
co-ordinating
clinicalinvestigators (where appointed) and……

h)te

Rationale / Comment :The adverse events and adverse device
effects that must be reported to thesponsor by investigator(s) should belimited to those that are serious. Also thesponsor is responsible to report only
serious adverse device effects toauthorities and ethics committee(s). The

MB = Member body (Enter two-letter country code, e. g. CN for China)
Type of comment: ge = generalte = technicaled = editorial

Proposed Changes : (Change to)h) ensure that all deviations from theclinical investigation plan, all serious
adverse events and all serious
adverse device effects are reported
and reviewed with the clinicalinvestigator(s)and,whereappropriate, that all serious adverse

NB Columns 1, 2, 4, 5 are compulsory
page 2

FORM 13B (ISO) 2001-07-01

ISO commenting template/Report of voting
1MBClause /subclause(e. g. 3.1)

Paragraph/
Figure/Table(e. g.
Table 1)

Typeofcom2
ment(e. g.
ed)

Date : 2001-11-05

Comments: Justification for change

Document: DIS 14155-1

Proposed change

Observations of the secretariat
on each comment submitted

ICH Guideline has an equivalent rule as events and all serious adverse
described above.
device effects shall be reported tothe relevant authorities and ethics
committee(s)and/orsafety
monitoring committee(s);JISC8.2i)

teRationale / Comment :The same reason as described in 8.2 h)

JISC

11.2

1st para,
3rd line

teRationale / Comment :Proposed Changes :rdThis sentence is not necessary as the 3 Delete “signed by the sponsor and clinicalparagraph
describes
thesame investigator(s),”requirement.
The “sponsor” should be included in the 3rdparagraph. See the next comment.

JISC

11.2

3rd para,
st1 line

teRationale / Comment :12(See the comment just before)

MB = Member body (Enter two-letter country code, e. g. CN for China)
Type of comment: ge = generalte = technicaled = editorialProposed Changes : (Change to)i) inform in writing all principal clinicalinvestigators about all serious
adverse device effects occurring in(multicentre)
clinicalinvestigators…..(delete “all seriousadverse events”)

Proposed Changes : (Change to)
The final report shall be presented inwritten form and signed by thesponsor,
theco-ordinatinginvestigator (where appointed) andtheprincipal
clinicalinvestigator(s)….

NB Columns 1, 2, 4, 5 are compulsory
page 3

FORM 13B (ISO) 2001-07-01

ISO commenting template/Report of voting1MBClause /subclause(e. g. 3.1)

Paragraph/Figure/Table(e. g.
Table 1)

Typeofcom2
ment(e. g.
ed)

Date : 2001-11-05

Comments: Justification for change

Document: DIS 14155-1

Proposed changeJISCAnnex Bo)

te

Rationale / Comment :Proposed Changes : (Change to)
To be consistent with the provision of 10.3 o) all reports on serious adversem).
device effects;

JISC

Annex C

C.10

te

Rationale / Comment :To be consistent with 10.3 l).

12

MB = Member body (Enter two-letter country code, e. g. CN for China)
Type of comment: ge = generalte = technicaled = editorial

Observations of the secretariat
on each comment submitted

Proposed Changes : (Change to)
It should be confirmed that theClinical Investigation Plan and its
anysignificant
changes
werereviewed by an ethics committee.

NB Columns 1, 2, 4, 5 are compulsory
page 4

FORM 13B (ISO) 2001-07-01