A new revision of MEDDEV 2.7.1 is now available and this revision represents a complete rewrite, with massive changes. The new MEDDEV is both more instructive, and more prescriptive in particular regarding the use of evidence from equivalent devices. So what exactly are the implications of all these changes for device manufactures? How does this affect your CERs? How long is the transition period going to be? (Hint: there’s typically no transition provided for the MEDDEVs). Join us for this free, 60 minute webinar, presented by our guest Keith Morel, VP of Regulatory Compliance at Qserve Group US Inc., on July 21st. (You can view the full webinar at: http://www.greenlight.guru/webinar/clinical-evaluation-eu-meddev-2_7_1-rev-4) Specifically, you will learn: What is MEDDEV 2.7.1. Rev 4 for Clinical Evaluation in EU and why exact does this matter to device makers? What are some of the most significant changes? (There are a lot of them) How does it align with the changes to the new EU MDR? In what ways will demonstrating “equivalence” now be harder? How often you must update your CERs now and what qualifications the evaluators must have? How should you prepare for the increased notified body scrutiny? How do you perform a clinical literature review to meet the new expectations? Do you need to write a CER for CE Marking? If not, when else do you need to do this and with what focus?

1. Understanding
the
changes
in
MEDDEV
2.7.1
rev
4
and
Their
Impact
Presented by:
Keith Morel, PhD
VP Regulatory Compliance

2. greenlight.guru
• Quality
Management
Software
Exclusively
for
Medical
Device
Companies
• Single
Source
of
Truth
• Manage
design
controls,
risk
and
quality
in
a
single,
easy-­‐to-­‐use
solution
• Customers
&
Partners
All
Over
the
Globe:
• Represented
on
5
continents
• www.greenlight.guru
Jed Johnson
PhD,
CTO
Nanofiber
Solutions
“greenlight.guru has
been
instrumental for us moving so
quickly through the
ISO
certification and I
would highly
recommend it.”

3. Qserve
Group
• Largest
European
Medical
device
consulting
firm
• A
global
reach:
• Offices
in
Amsterdam,
San
Francisco,
Boston
and
Nanjing
• One-­‐stop-­‐shopping
• All medical device
RA/QA/CA
needs
• Pragmatic
project
approach
• www.qservegroup.com
• Strong
International
team
• Technical,
regulatory,
quality and
clinical competences
• Ex
EU
Notified Body,
FDA
and
CFDA
staff
• Dr
Gert
Bos
is
a
partner
(RAPS
board
member;
key NB
rep.
in
MDR/IVDR
negotiations)
• Medical
Doctor
in
management
• WOFE
in
China
• Approvedas
a
CRO
• Native
speakers
in
8
languages

4. Contents
• Structure of the new Document
• The process of developing the new MEDDEV
• Who, how, timing?
• New expectations around Clinical Data & Evaluation in the EU
Regulations surrounding MEDDEV 2.7.1 rev 4 (i.e. the context)
• New requirements in MEDDEV 2.7.1 rev 4 (i.e. the content)
• Summary and Conclusions

5. Structure
of
the
Document:
rev
3
vs
rev
4
Rev 3 Rev 4
46 pages 64 pages
10 sections 12 sections
6 Appendices 12 Appendices

6. Structure
of
the
Document:
rev
3
vs
rev
4

7. Structure
of
the
Document:
rev
3
vs
rev
4

8. Development
of
rev
4:
Who?
When?
How?
MEDDEV 2.15 rev 3 • Task Force under the CIE, under Medical Device
Expert Group
• Participants in TF:
• CA
• NB
• Industry
• Patient Organizations
• Consultants
• Commission (observing)
• Similar people to MDR
Ø Consistency; gap analysis (and rev 5!) to come
• Published June 29, 2016
• No transition period. In theory these
requirements apply now!

9. Increasing
Requirements
in
Recent
Years
Joint audits
UAV
CoC audits
COEN - MS
EUDAMED
Electronic
submission
UDI
MDR / IVDR
EU oversight
Clinical trials
Scrutiny
procedure
and MORE….
2010 2013 ~2020
MEDDEV
2.7.1 rev 4
Mid 2016

10. New
expectations
surrounding
rev 4
1. Joint
NB
Audits
• Involvement
of
clinical
experts
in
technical
file
reviews
to
be
improved
• Appropriateness
of
Clinical
expertise/competence
of
clinical
expert
for
device
under
review
• NB
QMS
procedures
for
ensuring
appropriateness/validity
of
clinical
experts
opinion
• Clinical
competence
of
NB
staff
• Depth
of
review
of
clinical
investigations

11. New
expectations
surrounding
rev 4
1. Joint
NB
Audits
(continued)
• Processes
for
assessment
CER
needs
improvement
• Review
of
PMS
and
PMCF
plans
• Thoroughness
of
assessment
of
CER,
e.g.
‒ all
relevant
clinical
practice
considered;
‒ all
hazardous
situations
considered?;
‒ not
following
structure/guidance
in
MEDDEV
2.7.1;
‒ intended
use
supported
by
data?

12. New
expectations
surrounding
rev
4
2. New
Regulations
for
Medical
Devices
and
IVDs
in
Europe
• See
recent
recorded
webinar
by
Dr
Gert
Bos
• http://bit.ly/2a9naRI

13. New
Definitions
in
MEDDEV
2.7.1
rev
4
Definitions Comment
(aligned with)New No change Adjusted
Bias GHTF SG5/N2R8 (2007)
Class Effect Hazard due to
substances & technologies
Confusion/change
Clinical Data MDD
Clinical Evaluation
Clinical Evidence
Clinical Investigation EN ISO 14155 (2011)
Clinical Inv. Plan
Clinical Performance EN ISO 14155 (2011)
Clinical Safety
Clinical Use
Device Registry MEDDEV 2.12.2 rev 2
Equivalent Device MDD
Information Materials MDD (label/IFU/prom.)

14. New
Definitions
in
MEDDEV
2.7.1
rev
4
Definitions Comment
(Aligned with)New No change Adjusted
Incident MEDDEV 2.12.1
Intended Purpose MDD
Feasibility Study MEDDEV 2.7.2 rev 3
Hazard EN ISO 14971 (2012)
Harmonized Std. MDD
(Clinical) Investigator EN ISO 14155 (2011)
PMCF Plan MEDDEV 2.12.2 rev 2
PMCF Study MEDDEV 2.12.2 rev 2
Risk EN ISO 14971 (2012)
Risk Management EN ISO 14971 (2012)
SAE/AE EN ISO 14155 (2011)
Sufficient Clinical Evidence (from MDD)

15. Important
New/Adjusted
Definitions
in
rev
4
• PMCF
Plan
• the
documented,
proactive,
organised
methods
and
procedures
set
up
by
the
manufacturer
to
collect
clinical
data
based
on
the
use
of
a
CE-­‐marked
device
corresponding
to
a
particular
design
dossier
or
on
the
use
of
a
group
of
medical
devices
belonging
to
the
same
subcategory
or
generic
device
group
as
defined
in
Directive
93/42/EEC.
The
objective
is
to
confirm
clinical
performance
and
safety
throughout
the
expected
lifetime
of
the
medical
device,
the
acceptability
of
identified
risks
and
to
detect
emerging
risks
on
the
basis
of
factual
evidence

16. Important
New/Adjusted
Definitions
in
rev
4
• PMCF
Study
• A
study
carried
out
following
the
CE
marking
of
a
device
and
intended
to
answer
specific
questions
relating
to
clinical
safety
or
performance
(i.e.
residual
risks)
of
a
device
when
used
in
accordance
with
its
approved
labelling.
• Sufficient
Clinical
Evidence
• clinical
data
of
an
amount
and
quality
to
guarantee
the
scientific
validity
of
the
conclusions
(adapted
from
section
2.3.1
of
Annex
X
of
MDD)

17. Clinical
Evaluation
– what
is
it?
(6.1)
1.Clinical
evaluation
is
a
methodologically
sound
ongoing
procedure
to
collect
and
analyse
clinical
data
pertaining
to
a
medical
device
and
to
assess
whether
there
is
Sufficient
Clinical
Evidence
to
confirm
compliance
with
relevant
essential
requirements
for
safety
and
performance
when
using
the
device
according
to
the
manufacturer’s
Instructions
for
Use
2.Very
clear
in
rev
4
CER
needed
for
ALL
classes
of
medical
device
(class
I
and
up!)
3.Core
issues
are
the
proper
determination
of
the
benefit/risk
profile
in
the
intended
target
groups
and
medical
indications,
and
demonstration
of
acceptability of
that
profile based
on
the
state
of
the
art
in
the
medical
fields
concerned

18. Clinical
Evaluation
– focus
for
evaluators
(6.1)
# Issue Focus for evaluators
1 Intended use - ER 1, 3 Is this supported by Sufficient Clinical Evidence (SCE)?
2 Clinical Performance & Benefits - ER 1, 3, 6 Are these supported by Sufficient Clinical Evidence (SCE)?
3 Risk avoidance/risk mitigations in
“Information Material” ER 1, 3, 6
Are these supported by Sufficient Clinical Evidence (SCE)?
4 Usability for intended users (e.g.
professionals, lay-persons, disabled persons)
– ER 1
Is this supported by Sufficient Clinical Evidence (SCE)?
5 Suitability of “Information Material” for
intended users – ER 1
Is this supported by Sufficient Clinical Evidence (SCE)?
6 Sufficient instructions for intended users (e.g.
pregnant women, paediatrics) – ER 1
Consistent with the clinical data?

19. Clinical
Evaluation
during
Development
(6.2.1)
RISK MGMT
PMS CER
• Data needs
• Equivalence?
• Trial? Study
design
• Needs?
• Plan?
• PMCF?
Preclinical testing
• Needs

20. Clinical
Evaluation
for
Initial
CE
Marking
(6.2.2)
RISK MGMT
CERPMS
INFORMATION
MATERIALS
• Sufficient Clinical Evidence to
meet ERs?
• Significance of any clinical
risks after risk control
• Needs (subtle, long terms
effects)
• Plan
• PMCF?
• IFU appropriate for intended
users?
• All clinical risks in RMR?
• Risks controls ID and verified?
• Risk-Benefit justified?
Preclinical
testing
• All risk controls in IFU?
Validated?
• All warnings etc in RMR?
• Usability demonstrated?

21. Clinical
Evaluation
during
the
PMS
phase
(6.2.3)
INFORMATION
MATERIALS
• Needed
updates?
PMS
• Updated
Needs/Plan?
• PMS data
• SotA?
• Off label
use?
RISK MGMT
• New Haz. Sit.
• Adjust Risks
• New R vs B
• Claims
justified?
(old, new)
CER
• Update CER
• New Clinical
Data
• New R vs. B
• Claims
justified?
(old, new)

22. Clinical
Evaluation
during
the
PMS
phase
(6.2.3)
1.Manufacturer
must
DEFINE
and
JUSTIFY
frequency
of
updating
the
CER,
based
on:-­‐
i. Device
has
significant
risks?
(invasiveness,
high
risk
patient
population,
severity
of
disease
…
see
MEDDEV
2.12.2
rev
2)
ii. Device
is
well
established?
(innovation,
design
changes,
number
of
devices
used,
are
there
risks/uncertainties
in
long
term
&
has
this
period
been
covered?
…)
2.Update
CER
when:
i. New
PMS
info
with
potential
to
change
current
evaluation
ii. If
no
such
information
is
received,
at
least:
a. AT
LEAST
Annuallyif
“significant
risk”/not
well
established
b. Every
2-­‐5 years if
no
“significant
risk”/IS
well
established;
MUST
JUSTIFY
(coordinate
with
NB
for
certificate
renewals)

23. How
is
Clinical
Evaluation
Performed?
(6.3)
Scope
Section 7
App. A3
ID data
Section 8
App. A4-A5
Appraisal
Section 9
App. A6
Analysis
Section 10
App A7-A8
Finalize
CER
Section 11
App. A9-A10

24. Who
performs
Clinical
Evaluation?
(6.4)
• Suitably
qualified
individual
or
a
team
• The
manufacturer
should
take
the
following
aspects
into
consideration:
• requirements
for
evaluators
in
line
with
the
nature
of
the
device
under
evaluation
and
its
clinical
performance
and risks.
• The
manufacturer
should
be
able
to
justify
the
choice
of
the
evaluators
(qualifications;
documented
experience*),
and
to
present
a
declaration
of
interest*
(financial
interests,
conflicts
of
interest
– see
A11)
for
each.
‒ *Reviewed
by
NB.
‒ *“Independence”
does
not
appear.
‒ *
Not
explicit
how
they
are
to
assess
these
and
what
they
are
to
do

25. Who
performs
Clinical
Evaluation?
(6.4)
• As
a
general
principle,
the
evaluators
should
possess
knowledge
of
the
following:
1. the
device
technology
and
its
application;
2. research
methodology
(including
clinical
investigation
design
and
biostatistics);
3. diagnosis
and
management
of
the
conditions
intended
to
be
managed
or
diagnosed
by
the
device,
knowledge
of
alternative
treatments,
treatment
standards
and
technology
4. information
management
(e.g.
scientific
background
or
librarianship
qualification;
experience
with
relevant
databases)
5. regulatory
requirements;
and
6. medical
writing
(e.g.
post-­‐graduate
experience
in
a
relevant
science
or
in
medicine;
training
and
experience
in
medical
writing);

26. Who
performs
Clinical
Evaluation?
(6.4)
• The
evaluators
should
have
at
least
the
following
training
and
experience
in
the
relevant
field:
1. a
higher
degree and
5
years
of
documented
professional
experience;
or
2. 10
years
of
documented
professional
experience
if
a
higher
degree
is
not
a
prerequisite
for
a
given
task.
• There
may
be
circumstances
where
the
level
of
evaluator
expertise
may
be
less
or
different,
this
should
be
documented
and
justified

27. Scoping
(7.0)
• Define
scope,
based
on
the
ER
which
need
to
be
addressed
(e.g.
1,
3,
6
MDD)
• Nice
table
in
rev
4
highlighting
the
focus
for
the
CER
in
the
pre-­‐ and
post-­‐CE
Marking
situation
(see
previous
slides)
‒ Off-­‐label
use
is
included
in
the
post-­‐CE
phase
now
(cf.
rev
3)
• Annex
7 gives
lots
of
addition
guidance
on
how
to
analyse clinical
data
to
show
meet
the
ERs
(7
pages!)
• Won’t
address
all
of
this,
but
a
few
key
points
…

28. Scoping
(7.0/Annex
7)
– Key
Points
• ER
1,
Safety
• Risk
Mgmt -­‐>
all
hazards
covered
by
harmonized
stds?
‒ e.g.
60601-­‐1-­‐1
electrical
hazards
– hence
don’t
need
clinical
data
‒ e.g.
Usability
– 62366
– doesn’t
give
design
specifics,
therefore
may
need
clinical
data
to
show
risk
of
use
errors,
risks
due
to
ergonomic
issues
are
reduced
AFAP
• ER
1,
Acceptable
R-­‐B
ratio
• ER
1,
Clinical
risk
• ER
3,
Performance

29. Scoping
(7.0/Annex
7)
– Key
Points
• ER
6,
Undesirable
side
effects
• Must
be
acceptable
when
weighed
against
the
benefits
of
using
the
device
• Need
clinical
data
on
the:
‒ Nature,
severity
&
frequency
of
undesirable
side
effects
‒ Must
have
sufficient
sample
size
(N)
to
guarantee
the
scientific
validity
of
the
conclusion
(OTHERWISE
ER
6
NOT
MET!)
‒ Consider
the
state
of
the
art
(alternative
therapies,
baseline
devices
..)
• Make
sure
studies
are
big
enough!
(Binomial Distribution) 1 2 3 4 5 6
Chance of observing at least 1 event (%) 80 80 80 90 90 90
Actual probability of SAE (%) 10 5 1 10 5 1
Number of subjects needed 15 32 161 22 45 230

30. Identification
of
Data
(8.0,
8.1)
• Various
sources
identified
1.Data
generated
&
held
by
Manufacturer
a. Clinical
Investigation
data
(pre-­‐market)
b. Animal/Performance
data
c. PMS
data
a. PMS/trend
reports
b. Vigilance
reports
c. Complaints
d. FSCA
e. Compassionate
use/Humanitarian
Use

31. Identification
of
Data
(8.2)
2.Data
not
held
by
the
manufacturer
– Data
from
Literature
• Literature
searching
identifies
potential
sources
of
data
for
establishing:
• Current
knowledge/State
of
the
Art
‒ Alternative
therapies,
benchmark
devices,
medical
condition,
patient
population
‒ Potential
clinical
hazards
‒ Justify
criteria
for
equivalence
‒ Justify
validity
of
any
surrogate
end-­‐points
• Data
for
the
device
in
question

32. Key
points
in
rev
4
re
Literature
Searching
(8.2)
1.Search
strategy
should
be
thorough
&
objective
a. PICO
b. Cochrane
Handbook
for
Systematic
Reviews
c. PRIMSA
d. MOOSE
2.Use
Multiple search
strategies
to
get
all
information
3.Thorough
search
of
all
journals
• MEDLINE/PUBMED
good
starting
point
• May
need
to
include
EMBASE to
ensure
adequate
coverage
of
EU
journals
4.Need
a
protocol
for
literature
review
(as
in
rev
3)

33. Developing
Literature
Search
Question
-­‐ PICO
Example: in people with a prior history
of stroke, is blood pressure reduction
more effective than no treatment in
preventing future stroke events?

34. Appraisal
of
Clinical
Data
(9)
• Purpose
is
to
estimate
the
value
of
the
contribution
of
each
piece
of
clinical
data
to
the
assessment
of
clinical
safety
&
performance
• Uncertainty
about
the
value
of
the
data
comes
from:
1. Methodological
quality
of
the
data
2. Relevance
of
the
data
to
the
intended
use
• Many
ways
to
do
this
(e.g.
see
next
3
slides)
• Need
an
Appraisal
Plan
(part
of
CER)
detailing:
1. Criteria
for
determining
the
quality
and
scientific
validity
of
each
piece
of
data
2. Criteria
for
relevance
to
the
evaluation
3. Criteria
for
how
to
weight
the
contribution
of
each
piece
of
data

35. Contribution
of
each
data
set
-­‐ Appraisal
Criteria
-­‐ 1
Data
Suitability
• Appropriate
device
(D)
• Appropriate
device
application
(use)
(A)
• Appropriate
patient
group
(P)
• Acceptable
report/data
collection
(R)
Data
Contribution
• Data
source
type
(T)
• Outcome
measures
(O)
• Follow-­‐up
(F)
• Statistical
significance
(S)
• Clinical
significance
(C)
Each “Letter” or “Category” receives a 1, 2, or 3
Then weight the data
1 = actual device (or equivalent) as intended(on label),etc.
2 = actual device (or equivalent) off label in same anatomy, etc.
3 = competitor devices/state-of-art,different anatomy,etc.

36. Contribution
of
each
data
set
-­‐ Appraisal
Criteria
-­‐ 2
MEDDEV 2.7.1 Rev. 3
Appraisal Criteria for Suitability

37. Contribution
of
each
data
set
-­‐ Appraisal
Criteria
-­‐ 3
MEDDEV 2.7.1 Rev. 3
Appraisal Criteria for Data Contribution

38. Appraisal
of
Clinical
Data
(9)
• Lots
of
advice
on
how
to
assess
the
quality
and
scientific
validity
of
the
data
now
given
(section
9.3)
• How
to
determine
the
relevance
of
the
data
to
the
clinical
evaluation
(9.3.2)
• Pivotal
Data
must
come
from:
1. The
device
under
evaluation
2. An
equivalent
device
(see
next
slide)
• Weighting
• Use
pre-­‐defined
criteria
• RCT
noted
as
highest
weight
(increasing
emphasis
on
RCT)

39. Equivalence
(A1)
• Lots
of
details
given.
Some
highlights
1.Can
only
be
based
on
a
Single
device
(but …)
2.Same
general
criteria
given
(Clinical,
Technical,
Biological)
with
a
few
additions/clarifications
3.All
3
of
these
criteria
must
be
fulfilled
for
a
device
to
be
“equivalent”
4.Any
differences
must
be
clearly
identified,
disclosed,
evaluated
and
explanation
for
why
the
differences
are
not
expected
to
significantly
affect
the
performance
and
safety
of
the
device
are
to
be
given

40. Equivalence
(A1)
4.“If
measurements
are
possible,
clinically
relevant
specifications
and
properties
should
be
measured
both
in
the
device
under
evaluation
and
the
device
presumed
to
be
equivalent,
and
presented
in
comparative
tabulations”
• i.e.
must
OWN
(or
have
complete
access
to)
Technical
File/DD!
5.The
manufacturer
is
expected
to: include
the
supporting
non-­‐clinical
information
(e.g.
pre-­‐clinical
study
reports)
in
the
technical
documentation
of
the
device
• i.e.
must
OWN
(or
have
complete
access
to)
Technical
File/DD!
6.The
only
clinical
data
that
are
considered
as
relevant
are
the
data
obtained
when
the
equivalent
device: Is
a
medical
device
that
conforms
to
the
requirements
of
the
medical
device
directives.
• i.e.
if
non-­‐CE
Marked
(e.g.
510k,
CFDA
approval
..)
MAY
be
able
to
use
it,
but
must
justify
– same
device
intended
use,
patient
population,
medical
condition
…
etc;
also
issues
of:
‒ Any
differences
in
patient
population,
and
‒ clinical
practice
in
local
geography
cf.
Europe

41. Analysis
(10)
• Goal
of
Analysis
=
to
determine
if
the
appraised
data
sets
(taking
into
account
the
pivotal
data,
other
own
data,
and
the
literature
review
report)
available
for
a
medical
device
collectively
demonstrate
compliance
with
each
of
the
Essential
Requirements
in
relation
to
its
intended
use
‒ (See
previous
slides)
• Evaluators
needs
to
assess:
• Compliance
to
the
ERs
based
on
the
clinical
data
and
analysis
• Determine
any
gaps
and
if
a
clinical
investigation
is
needed
to
fill
those
gaps
ID pivotal
datasets
Look for
consistency
across such
datasets

42. When
Should
Additional
Clinical
Investigations
be
conducted
(A2)?
Considerations Additional Clinical
Investigation?
Implant (Annex X, 1.1a MDD)
Yes/(most likely)
High risk, class III (Annex X, 1.1a MDD)
Novel technologies
New clinical use for existing technology
Any gaps in data to identifybenefits, risks,claims,
side effects? (class I, IIa, Ib)

43. When
Should
Additional
Clinical
Investigations
be
conducted
(A2)?
• If
gap
analysis
reveals
any
gaps
in
data
are
sufficient
to
verify
that
device
meets
ERs
• Special
attention
should
be
paid
to:
• new
design
features,
including
new
materials,
• new
intended
uses
(including
new
medical
indications),
• new
claims,
• new
types
of
users
(e.g.
lay
persons),
• seriousness
of
direct
and/or
indirect
risks,
• contact
with
mucosal
membranes
or
invasiveness,
• …..

44. When
Should
Additional
Clinical
Investigations
be
conducted
(A2)?
• Special
attention
should
be
paid
to
(continued):
• ………
• increasing
duration
of
use
or
numbers
of
re-­‐applications,
• incorporation
of
medicinal
substances,
• use
of
animal
tissues
(other
than in
contact
with
intact
skin),
• issues
raised when
medical
alternatives
with
lower
risks
or
more
extensive
benefits
to
patients
are
available
or
have
become
newly
available,
• whether
the
data
of
concern
are
amenable
to
evaluation
through
a
clinical
investigation

45. In
summary
1. Rev
4
is
a
complete
rewrite
of
the
MEDDEV
2. It
is
clearer,
more
prescriptive
3. It
is
much
harder
to
demonstrate
equivalence
now
-­‐ essentially
only
if
you
own
the
technical
file
for
the
devices
to
be
used
4. Clinical
Investigations
will
need
to
be
conducted
more
often
5. The
requirements
for
the
expertise
of
the
evaluators
has
increased,
and
the
requirements
are
clearer

46. In
summary
6. The
focus
for
CER
at
various
stages
is
clearer
now
7. Greater
expectations
are
being
put
on
the
NB
now
(hence
more
in-­‐depth
reviews
of
CERs)
• The
clinical
expertise
requirement
for
staff
has
increased.
• It
is
expected
they
medical
doctors/professionals
on
staff.
• The
QMS
procedures
for
assessment
of
CER
have
increased.
• Clinical
experts
will
now
have
to
be
part
of
the
on-­‐site
audit
team
where
CER
are
assessed
on
site
(e.g.
renewals,
class
IIa and
IIb initial
assessments).
• A
CEAR
will
have
to
be
written
now,
and
provided
to
Expert
Panel
for
review

47. In
summary
8. It
is
clearer
when
PMCF
is
needed
now
(more
often,
in
general)
9. The
links
between
CER-­‐Risk-­‐PMS
and
CER-­‐IFU
are
emphasized
(maybe
stricter
reviews
by
NB?)
10. The
scoping
of
the
CER
is
clearer
now.
Which
ERs
are
to
be
address
by
the
CER
(1,3,6
for
MDD)
are
now
much
more
explicit,
as
is
the
assessment
required
to
be
conducted
and
recorded
in
the
CER
for
each
of
these.
11. Assessment
of
Usability
more
explicitly
part
CER
now
12. Include
EMBASE
now
(and
criteria
for
selection
of
adequate
databases)
13. MEDDEV
2.7.1
rev
4
was
published
June
29,
2016.

48. Thank
you
for
your
attention
What
questions
can
we
answer?
Keith Morel,PhD
VP Regulatory Compliance
ke i t h.m or e l @ qs e r ve gro up.c om
+1 916 606 4820 ( c e l l )