Medical Devices Regulation (MDR) 2017/745 - Clinical investigations

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CLINICAL
INVESTIGATIONS
MEDICAL DEVICES REGULATION (MDR) 2017/745
CHAPTER VI
PAGE 1

General
requirements
to
demonstrate
conformity
 Article 63 to 80, Annex XV
 Sponsor/Legal representative (EU) required t...

General Requirements
 Test device under normal conditions of use
 Establish/verify that the device is suitable for
inten...

Conditions
SPONSOR’S OBLIGATIONS
 Authorization by Member States required
 Ethics committee has not issued a negative
op...

 Study needs to be conducted in line with ethical principles
 Appropriate plan of investigation
 Adequate number of obs...

PAGE 6
 Written, dated, signed
 Subject or legally designated
representative
 Protection of vulnerable populations
(Art...

 Clear, concise, understandable
 Enables subject to understand the nature, objectives, implications, risks and inconveni...

PAGE 8
(Article 63 to 68)
Vulnerable populations
Incapacitated subjects:
 Consent of legally designated
representative
 ...

(Article 63 to 67)
Vulnerable populations
PAGE 9
Minors:
 Consent of legally designated
representative
 Child shall be p...

Pregnant and breastfeeding women:
 Clinical investigation has the potential to produce a direct benefit for
the pregnant ...

(Article 63 to 67)
Vulnerable populations
PAGE 11
Member States may maintain additional measures regarding persons
perform...

 Sudden medical emergency, no prior consent
 Expectation of direct clinical benefit
 Consent not obtainable within ther...

(Article 68)
PAGE 13
Damage
compensation
 Responsibility of Member States to ensure
systems for compensation exist
 Insu...

Application for clinical
investigation
 Article 70, Chapter II of Annex XV
 Sponsor applies to Member State
 Electronic...

Application Documentation
PAGE 15
Sponsor’s details
Investigation title
Clinical evaluation
plan
Device details
Target pop...

Application form
 Sponsor’s and manufacturer’s details
 Title of the clinical investigation
 Status of the application,...

Application form
 Summary of the clinical investigation
plan: objectives, subjects, inclusion
criteria, design, dates
 C...

Investigator’s brochure (IB)
 Clinical and non-clinical information on the investigational device
 Identification and de...

Investigator’s brochure (IB)
 Pre-clinical evaluation
 Existing clinical data: scientific literature, clinical data
 Su...

Clinical investigation plan
Rationale, objectives
Design methodology
Monitoring, conduct
Record-keeping
Method of ana...

Other information
 Statement of conformity with Annex I
 Opinion of ethic committee
 Proof of insurance
 Patient infor...

Clinical Investigation may start
PAGE 22
Class I devices, non-invasive class IIa and class IIb devices:
 Immediately aft...

Assessment by member
states
 Avoid conflict of interest
 Assessment done jointly by a team
 Design, data reliability an...

Conductofa
Clinical
Investigation
PAGE 24
• Sponsor and investigator shall ensure that the clinical
investigation is condu...

Electronic system on
clinical investigations
 Maintained by the European
Commission
 ID # for clinical investigations
 ...

Clinical investigations: devices bearing CE marking
(PMCF INVESTIGATION)
Where a clinical investigation is to be conducted...

Substantial
modifications to
clinical investigations
 Sponsor shall notify the Member
State of any modifications that
may...

Corrective measures
by member states
 Revoke authorization
 Suspend/terminate investigation
 Request modification
 All...

Information at the end of clinical investigation
 Sponsor shall inform all Member
States where the investigation takes
pl...

Coordinated assessment
procedure
 Single application
 Multicentric clinical investigations
have one coordinating Member ...

Grounds for refusal
Member State can disagree with the
conclusion of coordinating Member
State:
 The subjects would recei...

Reporting adverse events
Recorded by sponsor:
 Any adverse event considered critical in the
investigation plan
 All seri...

Other obligations of sponsors
 Keep documentation and provide it to
competent authorities upon request
 10 years (implan...

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