POST MARKET CLINICAL FOLLOW UP
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Transcript of POST MARKET CLINICAL FOLLOW UP
TÜV SÜD Product Service GmbH
POST MARKET CLINICAL POST MARKET CLINICAL FOLLOW UPFOLLOW UP
(MEDDEV 2.12-2 May 2004)
Dr. med. Christian Schübel
TÜV SÜD Product Service GmbH 21.04.23Abteilung: 2
2007/47/EG – Änderungen Klin. Bewertung
Historie:Historie:
CETF – Report (2000)
Qualität der klinischen Daten zu schlecht
Zu wenige klinische Prüfungen
Im Vorgriff auf die Revision der MDD publiziert:
• MEDDEV 2.7.1. – Clinical Evaluation
• MEDDEV 2.12-2 – Post Market Clinical Follow Up
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Post market surveillance may Post market surveillance may
include:include:
active supervision by customer
surveys
inquiries of users and patient
literature reviews
post market clinical follow up
PMCF – MEDDEV 2.12-2
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Annex II:Annex II:
5.2. The manufacturer must authorize the notified body to carry
out all necessary inspections and supply it with all relevant
information, in particular
[...]
the data stipulated in the part of the quality system relating to
design, such as the results of analyses, calculation test, the
solutions adopted in accordance with Annex I section(2),
preclinical and clinical evaluation, post-market clinical follow-
up and results of the post-market clinical follow up, if
applicable
[...]
2007/47/EG – Änderungen Klin. Bewertung
2007/47/EG – Änderungen Klin. Bewertung
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Klinische Daten – Anhang X
• Die klinische Bewertung und ihre Dokumentation müssen aktiv anhand der aus der Überwachung nach dem Inverkehrbringen erhaltenen Daten auf dem neuesten Stand gehalten werden
• Wird eine klinische Überwachung PMCF – Post Market Clinical Follow UP nach dem Inverkehrbringen […] nicht für erforderlich gehalten, muss dies ordnungsgemäß begründet und dokumentiert werden.
MEDDEV 2.12-2
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PMCF should always considered for devices PMCF should always considered for devices
where:where:
In the case the assessment of a product is
performed through the concept of equivalence
(“literature route” !)
identification of possible emerging risks is critical
the evaluation of long term safety and performance
is critical (implants !)
PMCF – MEDDEV 2.12-2
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Criteria to identify emerging risk:Criteria to identify emerging risk:
innovation
severity of the disease
sensitive target population
risky anatomical site
well known risks from literature or marketed
devices
obvious discrepancy between the pre-market
follow up timescale and the expected life of the
product
PMCF – MEDDEV 2.12-2
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All PMCF should be planned:All PMCF should be planned:
form of extended follow-up of patients
enrolled in the pre-market trials
and/or
a prospective study of a representative
subset of patients after the device is placed
on the market
PMCF – MEDDEV 2.12-2
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This plan will need to take into account:This plan will need to take into account:
Results of the clinical investigation including
Adverse events identified
Average life expectancy of the device
The claims made by the manufacturer for the
device
Performances for which equivalence is
claimed
New information becoming available
PMCF – MEDDEV 2.12-2
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No PMCF:No PMCF:
Products for which the medium/long term clinical
performance and safety is already known from
previous use of the device
or
from fully transferable experience with equivalent
devices (Products quoted as "equivalent"
devices where reference product is subjected to
PMCF)
PMCF – MEDDEV 2.12-2
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ConclusionConclusion
PMCF – Plan
Follow up of a pre-market trial
Post-market prospective trial (cave: national
requirements!)
The notified body should review the appropriateness
of the plan and the procedures
The follow-up should take into account the average
life expectancy
In the case the assessment of a product is
performed through the concept of equivalence,
PMCF should always be considered.
PMCF – MEDDEV 2.12-2
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Möglichkeiten eines PMCF:Möglichkeiten eines PMCF:
• Fortführung einer klinischen Prüfung (z.B. Herzklappen)
• Planung einer neuen klinischen Prüfung, klinischen Studie(Achtung bei zusätzlichen invasiven oder belastenden Untersuchungen - MPG §23)
• Durchführung einer sogenannten Registry
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Post Market Clinical Follow Up
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Requirements for documentation of Post Market Clinical Follow Up (PMCF) activities:
NOTE:
Results of PMCF and link to risk management are not addressed in MEDDEV 2.12-2
PMCF – MEDDEV 2.12-2
TÜV SÜD Product Service GmbH 21.04.23Abteilung: 14
Post-Market Clinical Follow-Up
Post-Market Surveillance
Risk Management
PMCF – MEDDEV 2.12-2