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EU Clinical Investigations
Dr Annet Muetstege
Medical Device Clinical Trial Symposium Taipei
05-SEP-2018
Key definitions 1/2
• Clinical data:
MEDDEV 2.7/1: The safety and/or performance information that is generated
from the clinical use of a device.
• Clinical Use:
MEDDEV 2.7/1: Use of a medical device in or on living human subjects.
Note: Includes use of a medical device that does not have direct patient
contact.
• Sufficient clinical evidence:
MEDDEV 2.7/1: An amount and quality of clinical evidence to guarantee the
scientific validity of the conclusions.
• State of the art:
MEDDEV 2.7/1: Information relating to the medical condition managed with
the device and its natural course, benchmark devices, other devices and
medical alternatives available to the target population.
ACS-Clinical Evaluation & Investigation |
TFDA 20180905
2
Key definitions 2/2
• Clinical investigation:
ISO 14155 - systematic investigation in one or more human subjects,
undertaken to assess the safety or performance of a medical device
NOTE “Clinical trial” or “clinical study” are synonymous with “clinical investigation”
• Premarket Study:
MEDDEV 2.7/3 - Clinical investigation conducted with:
a) Non-CE marked devices,
b) CE marked devices used outside the intended use(s) covered by the CE
marking.
• Postmarket/ PMCF Study:
MEDDEV 2.12/2 - 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.
ACS-Clinical Evaluation & Investigation |
TFDA 20180905
3
Clinical Evidence gaps?
• Premarket
➢First round clinical evaluation indicates there is
insufficient qualitative data to verify that the device
meets the ER’s
➢Classical Clinical Investigation
• Postmarket
➢Clinical evaluation indicates there are uncertainties or
unanswered questions regarding safety or performance
➢Post Market Clinical Followup
ACS-Clinical Evaluation & Investigation |
TFDA 20180905
4
Clinical Evidence gaps?
• Premarket Clinical Investigation (MEDDEV 2.7/1):
➢ Implants and high-risk devices and devices that extend the
intended purpose are likely to require clinical investigation data,
but also
➢ New technologies, and class I, IIa, and IIb devices with clinical
evidence gaps
ACS-Clinical Evaluation & Investigation |
TFDA 20180905
5
Clinical Evidence gaps?
• Postmarket Clinical Follow-Up (MEDDEV 2.12/2):
➢ The manufacturer should aim at including all patients in PMCF
studies for a device:
• that carries significant risks, or
• for rare diseases
➢ Other cases include:
• premarket follow-up time scales and the expected life of the
product,
• where CE marking was based on equivalence
ACS-Clinical Evaluation & Investigation |
TFDA 20180905
6
EU Clinical Study Regulatory
• Premarket
➢ MDD, Declaration of Helsinki, ISO 14155, MEDDEV 2.7/3
• Postmarket
➢ MDD, Declaration of Helsinki, ISO 14155, MEDDEV 2.12-1 and
2.12/2
• Local requirements
➢ Different per country
• MDR
➢ More attention clinical investigation
➢ ISO 14155,
➢ Includes all Post-market studies
ACS-Clinical Evaluation & Investigation |
TFDA 20180905
7
0
100
200
300
400
MDD MDR
Count "investigation"
Clinical Investigation requirements
• CIP/ protocol
• IB or equivalent documentation
• Informed Consent Form and any other written information to be
provided to subjects
• Procedures for recruiting subjects and advertising materials, if any
• Qualifications of the principal investigator and team
• Study insurance
• Applicable regulatory approvals
• AE documentation & reporting
• Progress and final reports
ACS-Clinical Evaluation & Investigation |
TFDA 20180905
8
Clinical Investigation - endpoints
• Safety
➢ Adverse Events
➢ Type and number of AE’s
• Performance
➢ Depends on device involved
• Patient benefit
➢ Mortality, morbidity, QoL
• Timing/ duration of effect(s)
➢ Patient follow-up
ACS-Clinical Evaluation & Investigation |
TFDA 20180905
9
Clinical Investigation - design
• RCT or single arm; single or multicenter; interventional or
observational; short or long term patient follow-up?
➢ What is the clinical evidence gap?
➢ State of the Art/ Standard of Care -> International differences?
➢ New treatment or first of its kind?
➢ Pre- or Postmarket study?
➢ Standards?
➢ Scope -> Multiple use of clinical data?
ACS-Clinical Evaluation & Investigation |
TFDA 20180905
10
Conclusion
• EU - higher clinical evidence demands
➢ Definitions more comprehensive
➢ Clinical evaluation requires more clinical data throughout the
Product Life Cycle
➢ Regulatory environment becoming more strict for medical device
Pre- and Postmarket studies
➢ Clinical studies are expensive and people are not guinea pigs ->
even more careful development of clinical studies is needed
ACS-Clinical Evaluation & Investigation |
TFDA 20180905
11
Questions?
info@appliedclinicalservices.com
ACS-Clinical Evaluation & Investigation |
TFDA 20180905
12

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EU Clinical Investigations Taipei 2018

  • 1. EU Clinical Investigations Dr Annet Muetstege Medical Device Clinical Trial Symposium Taipei 05-SEP-2018
  • 2. Key definitions 1/2 • Clinical data: MEDDEV 2.7/1: The safety and/or performance information that is generated from the clinical use of a device. • Clinical Use: MEDDEV 2.7/1: Use of a medical device in or on living human subjects. Note: Includes use of a medical device that does not have direct patient contact. • Sufficient clinical evidence: MEDDEV 2.7/1: An amount and quality of clinical evidence to guarantee the scientific validity of the conclusions. • State of the art: MEDDEV 2.7/1: Information relating to the medical condition managed with the device and its natural course, benchmark devices, other devices and medical alternatives available to the target population. ACS-Clinical Evaluation & Investigation | TFDA 20180905 2
  • 3. Key definitions 2/2 • Clinical investigation: ISO 14155 - systematic investigation in one or more human subjects, undertaken to assess the safety or performance of a medical device NOTE “Clinical trial” or “clinical study” are synonymous with “clinical investigation” • Premarket Study: MEDDEV 2.7/3 - Clinical investigation conducted with: a) Non-CE marked devices, b) CE marked devices used outside the intended use(s) covered by the CE marking. • Postmarket/ PMCF Study: MEDDEV 2.12/2 - 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. ACS-Clinical Evaluation & Investigation | TFDA 20180905 3
  • 4. Clinical Evidence gaps? • Premarket ➢First round clinical evaluation indicates there is insufficient qualitative data to verify that the device meets the ER’s ➢Classical Clinical Investigation • Postmarket ➢Clinical evaluation indicates there are uncertainties or unanswered questions regarding safety or performance ➢Post Market Clinical Followup ACS-Clinical Evaluation & Investigation | TFDA 20180905 4
  • 5. Clinical Evidence gaps? • Premarket Clinical Investigation (MEDDEV 2.7/1): ➢ Implants and high-risk devices and devices that extend the intended purpose are likely to require clinical investigation data, but also ➢ New technologies, and class I, IIa, and IIb devices with clinical evidence gaps ACS-Clinical Evaluation & Investigation | TFDA 20180905 5
  • 6. Clinical Evidence gaps? • Postmarket Clinical Follow-Up (MEDDEV 2.12/2): ➢ The manufacturer should aim at including all patients in PMCF studies for a device: • that carries significant risks, or • for rare diseases ➢ Other cases include: • premarket follow-up time scales and the expected life of the product, • where CE marking was based on equivalence ACS-Clinical Evaluation & Investigation | TFDA 20180905 6
  • 7. EU Clinical Study Regulatory • Premarket ➢ MDD, Declaration of Helsinki, ISO 14155, MEDDEV 2.7/3 • Postmarket ➢ MDD, Declaration of Helsinki, ISO 14155, MEDDEV 2.12-1 and 2.12/2 • Local requirements ➢ Different per country • MDR ➢ More attention clinical investigation ➢ ISO 14155, ➢ Includes all Post-market studies ACS-Clinical Evaluation & Investigation | TFDA 20180905 7 0 100 200 300 400 MDD MDR Count "investigation"
  • 8. Clinical Investigation requirements • CIP/ protocol • IB or equivalent documentation • Informed Consent Form and any other written information to be provided to subjects • Procedures for recruiting subjects and advertising materials, if any • Qualifications of the principal investigator and team • Study insurance • Applicable regulatory approvals • AE documentation & reporting • Progress and final reports ACS-Clinical Evaluation & Investigation | TFDA 20180905 8
  • 9. Clinical Investigation - endpoints • Safety ➢ Adverse Events ➢ Type and number of AE’s • Performance ➢ Depends on device involved • Patient benefit ➢ Mortality, morbidity, QoL • Timing/ duration of effect(s) ➢ Patient follow-up ACS-Clinical Evaluation & Investigation | TFDA 20180905 9
  • 10. Clinical Investigation - design • RCT or single arm; single or multicenter; interventional or observational; short or long term patient follow-up? ➢ What is the clinical evidence gap? ➢ State of the Art/ Standard of Care -> International differences? ➢ New treatment or first of its kind? ➢ Pre- or Postmarket study? ➢ Standards? ➢ Scope -> Multiple use of clinical data? ACS-Clinical Evaluation & Investigation | TFDA 20180905 10
  • 11. Conclusion • EU - higher clinical evidence demands ➢ Definitions more comprehensive ➢ Clinical evaluation requires more clinical data throughout the Product Life Cycle ➢ Regulatory environment becoming more strict for medical device Pre- and Postmarket studies ➢ Clinical studies are expensive and people are not guinea pigs -> even more careful development of clinical studies is needed ACS-Clinical Evaluation & Investigation | TFDA 20180905 11