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POST MARKET CLINICAL FOLLOW UP

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:

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POST MARKET CLINICAL FOLLOW UP

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  1. POST MARKET CLINICAL FOLLOW UP (MEDDEV 2.12-2 May 2004) Dr. med. Christian Schübel

  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 Abteilung:

  3. PMCF – MEDDEV 2.12-2 Post market surveillance may include: • active supervision by customer surveys • inquiries of users and patient • literature reviews • post market clinical follow up

  4. 2007/47/EG – Änderungen Klin. Bewertung 2007/47/EG – Änderungen Klin. Bewertung 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 • [...]

  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 Abteilung:

  6. PMCF – MEDDEV 2.12-2 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 !)

  7. PMCF – MEDDEV 2.12-2 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

  8. PMCF – MEDDEV 2.12-2 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

  9. PMCF – MEDDEV 2.12-2 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

  10. PMCF – MEDDEV 2.12-2 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)

  11. PMCF – MEDDEV 2.12-2 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.

  12. Post Market Clinical Follow Up Möglichkeiteneines 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 Abteilung:

  13. PMCF – MEDDEV 2.12-2 • 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

  14. PMCF – MEDDEV 2.12-2 Risk Management Post-Market Surveillance Post-Market Clinical Follow-Up Abteilung:

  15. PMCF – MEDDEV 2.12-2 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

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