post market clinical follow up

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TÜV SÜD Product Service GmbH POST MARKET CLINICAL POST MARKET CLINICAL FOLLOW UP FOLLOW UP (MEDDEV 2.12-2 May 2004) Dr. med. Christian Schübel

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POST MARKET CLINICAL FOLLOW UP. (MEDDEV 2.12-2 May 2004). Dr. med. Christian Schübel. 2007/47/EG – Änderungen Klin. Bewertung. Historie: CETF – Report (2000) Qualität der klinischen Daten zu schlecht Zu wenige klinische Prüfungen Im Vorgriff auf die Revision der MDD publiziert: - PowerPoint PPT Presentation

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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

TÜV SÜD Product Service GmbH

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

TÜV SÜD Product Service GmbH

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

TÜV SÜD Product Service GmbH 21.04.23Abteilung: 5

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

TÜV SÜD Product Service GmbH

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

TÜV SÜD Product Service GmbH

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

TÜV SÜD Product Service GmbH

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

TÜV SÜD Product Service GmbH

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

TÜV SÜD Product Service GmbH

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

TÜV SÜD Product Service GmbH

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

TÜV SÜD Product Service GmbH

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

21.04.23Abteilung: 12

Post Market Clinical Follow Up

TÜV SÜD Product Service GmbH

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

TÜV SÜD Product Service GmbH

Content of an integrated Risk Management File:

NOTE:

Timeframes for Risk Management File update (addressed in RM SOP / RM Plan) should be in compliance with PMCF plan and design of clinical follow up studies

PMCF – MEDDEV 2.12-2