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14.05.2012. Abteilung:. 2. 2007/47/EG nderungen Klin. Bewertung. Historie:CETF Report (2000)Qualitt der klinischen Daten zu schlechtZu wenige klinische Prfungen Im Vorgriff auf die Revision der MDD publiziert:MEDDEV 2.7.1. Clinical EvaluationMEDDEV 2.12-2 Post Market Clinical Fo
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1. POST MARKET CLINICAL FOLLOW UP (MEDDEV 2.12-2 May 2004)
2. 15.05.2012 Abteilung: 2 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:
MEDDEV 2.7.1. – Clinical Evaluation
MEDDEV 2.12-2 – Post Market Clinical Follow Up
3. Post market surveillance may include:
active supervision by customer surveys
inquiries of users and patient
literature reviews
post market clinical follow up PMCF – MEDDEV 2.12-2
4. 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
5. 15.05.2012 Abteilung: 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.
6. PMCF should always considered for devices 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
7. 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
8. 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
9. 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
10. 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
11. Conclusion
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
12. 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
15.05.2012 Abteilung: 12 Post Market Clinical Follow Up
13. 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
14. 15.05.2012 Abteilung: 14 PMCF – MEDDEV 2.12-2
15. 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