Medical Devices Regulation (MDR) 2017/745 - Clinical Evaluation & Post-Market Clinical Follow-Up See more https://www.aretezoe.com/medical-devices

1. CLINICALEVALUATION
&
POST-MARKETCLINICAL
FOLLOW-UP(PMCF)
MEDICAL DEVICES REGULATION (MDR) 2017/745
CHAPTER VI, Article 61
Article 84, ANNEX XIV
PAGE 1

2. PAGE 2
CLINICAL EVALUATION
• General safety and performance
requirements
• Evaluation of side effects
• Benefit risk ratio
• Sufficient clinical evidence
• Clinical evaluation plan

3. PAGE 3
CONSULTING EXPERT PANEL
• Class III and IIb devices
• Manufacturer can consult an
expert panel to review its strategy
• Recommendation shall be
documented in the Clinical
Evaluation Report

4. Methodologically sound procedure
• Critical evaluation of scientific literature
• Data relate to data of equivalent device
• Data adequately demonstrate compliance with Annex I (general
safety and performance requirements)
• Critical evaluation of all available clinical investigations
• Currently available treatment options
PAGE 4

5. CLINICAL INVESTIGATION WAIVED
PAGE 5
Clinical Investigation must be performed for implantable and class III devices, except:
DESIGN MODIFICATIONS
Design modifications of a
device already marketed by
the same manufacturer, if the
modified device is equivalent
to the marketed device (as
endorsed by NB)
GENERIC DEVICES
Generic devices - contract with
original manufacturer
providing access to technical
data required
ACTIVE IMPLANTABLE
DEVICES
Active implantable devices
(sufficient clinical data,
Common Specifications)
WELL-ESTABLISHED
TECHNOLOGIES
Well-established technologies:
sutures, staples, dental fillings,
dental braces, tooth crowns,
screws, wedges, plates, wires,
pins, clips or connectors
(sufficient clinical data,
Common Specifications)

6. PAGE 6
EXEMPTED DEVICES
The Commission is empowered to
adopt delegated acts to amend the
list of exempted devices by adding
or removing other types of
implantable or class III devices

7. PAGE 7
PRODUCTS W/O INTENDED
MEDICAL PURPOSE
• Devices listed in Annex XVI
• Requirement to demonstrate the
performance of the device in lieu
of clinical benefit
• Clinical evaluations is based on
safety data, PMCF, and clinical
investigation
• Clinical investigations can be
waived if clinical data from an
analogous device is sufficient.

8. PAGE 8
CLINICAL EVALUATION
• Manufacturer shall justify in
technical documentation why
clinical evaluation is adequate
• Documentation shall be updated
throughout product lifecycle
• Data from PMCF shall be used for
update
• CLINICAL EVALUATION REPORT
(Part of Technical documentation,
Annex II)

9. CLINICAL EVALUATION
ANNEX IV PART A
• Clinical evaluation plan
• Thorough and objective
evaluation
• Equivalent device may be
used
• Generate report
PAGE 9

10. Clinical evaluation plan
Establish and update a clinical evaluation plan:
 Identify requirements that require support from relevant clinical data
 Specify intended purpose of the device
 Specify target groups, indications and contra-indications
 Describe intended clinical benefits with relevant clinical outcome parameters
 Specify methods of examination of qualitative and quantitative aspects of clinical safety
 Specify methods of determination of residual risks and side-effects
 List parameters to determine acceptability of the benefit-risk ratio for each indication
 How to conduct benefit-risk assessment of pharmaceuticals, nonviable animal or human tissues
 Indicate progression from exploratory to confirmatory investigations and PMCF
PAGE 10

11. Clinical evaluation
• Establish and update a clinical evaluation plan:
• Literature review: Identify available clinical data and any gaps in clinical evidence
• Appraise all relevant clinical data
• Generate new clinical data through clinical investigations
• Analyze all relevant clinical data
•  Conclusions about the safety and clinical performance, clinical benefits
• Clinical evaluation must be thorough and objective
PAGE 11

12. PAGE 12
DATA BASED ON EQUIVALENT
DEVICE
Clinical evaluation based on data of
an equivalent device:
• Technical similarity
• Biological: materials, substances
• The same clinical condition

13. PAGE 13
RESULTS OF CLINICAL
EVALUATION
Clinical evaluation report
• Clinical evidence shall support the
assessment of conformity.
• Clinical evidence, non-clinical data
and other relevant documentation
shall be part of the technical
documentation.
• Both favorable and unfavorable
data shall be included in the
technical documentation.

14. POST-MARKET CLINICAL FOLLOW-UP
• Annex XIV Part B
• PMCF is a continuous process that
updates clinical evaluation
• Specified in post-market
surveillance plan
• Acceptability of existing risks
• Detection of emerging risks
PAGE 14

15. PMCFPlan:
Methods&
Procedures
OBJECTIVES:
• Confirm safety and performance of the device throughout its
expected lifetime
• Identify new side-effects
• Monitor identified side-effects and contraindications
• Detect emergent risks
• Ensure continued acceptability of the benefit-risk ratio
• Identify possible systematic misuse or off-label use of the
device
• Verify correctness of the intended purpose
PAGE 15

16. PMCF Plan: Content
General methods and procedures
• Gathering of clinical experience,
• Feedback from users,
• Screening of scientific literature
• Collecting other sources of data
Specific methods and procedures
(specific registries)
PAGE 16
• Rationale for appropriateness of methods
• Objectives to be addressed by PMCF
• Reference to relevant parts of the clinical
evaluation report
• Reference to common specifications and
harmonized standards used
• Evaluation of clinical data relating to
equivalent devices
• Time schedule for PMCF activities
• Findings & Conclusions