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Outline
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From 13485 to the IVDD

  • Lew Farris
  • Medical Lead Auditor
  • TUV Rheinland of North America
  • September 15, 2006
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From 13485 to the IVDD

  • ß ß ß ß à à à à
  • Past (13485)   Future (IVDD)
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From 13485 to the IVDD
  • 13485:2003 transition
  • -  How did we do?
  • -  Lessons learned


  • IVDD update
  • -  Proposed changes to CTS
  • -  Genetic test: French position
  • -  Life Sciences and Biotechnology
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From 13485 to the IVDD
  • 13485:2003 transition
  • - Certification audits over the last year:
  • n=64 companies
  • deviations/audit
  • US          5.7
  • Ex-US          4.6
  • MDD          5.2
  • IVDD          6.2
  • 2005        ~5.0
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From 13485 to the IVDD
  • 13485:2003 transition
  • -  Top 5 deviations by type
  • 1.  Process approach
  • 2.  Distributor contract
  • 3.  Risk management
  • 4.  Supplier qualification
  • 5.  Internal audits
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From 13485 to the IVDD
  • 13485:2003 transition
  • -  Future considerations:
  • 1.  Expand on Process Approach       (e.g. QM, objectives vs metrics)
  • 2.   Format quality manual to 13485:2003 (clauses)
  • 3.  Make sure technical files are living documents
  • 4.  Training (competency)
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From 13485 to the IVDD
  • 13485:2003 transition



  • -  Questions???
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From 13485 to the IVDD
  • IVDD update, courtesy of:
  • -  Dr. Heiner Luedemann
  •    IVDD Worldwide Technical Expert
  •    TRPS, Cologne, Germany
  •    and member of
  •    IVDD Technical Working Group,
  •    European Commission, Brussels
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From 13485 to the IVDD
  • IVDD update
  • Most important, there are no changes to the IVDD planned to go into force in the near future (1 – 2 years)
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From 13485 to the IVDD
  • IVDD update
  • -  Proposed changes to CTS
  • 1.  28 recommendations from IVDD TWG dated 8 February 2006
  • 2.  Expand to include Annex II, list B
  • 3.  “Same-day” fresh samples in performance evaluation (HIV)
  • 4.  Add serotyping requirements to genotyping assays for HCV
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From 13485 to the IVDD
  • IVDD update
  • -  Proposed changes to CTS
  • 5.  Performance evaluation to include same state-of-the-art (CE marked)
  • 6.  Establish acceptance criteria for seroconversion (Portuguese IVD Tech Committee proposal)
  • 7.  Delineate between viral typing and viral confirmation assays
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From 13485 to the IVDD
  • IVDD update
  • -  Genetic test: French position (Feb 2006)
  • 1.  Add products (Annex II) that detect presence, absence, mutation or expression of human gene
  • 2.  Only genotype test with medical purpose
  • 3.  Examples could be: susceptibility testing and prenatal testing
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From 13485 to the IVDD
  • IVDD update
  • -  Genetic test: French position (Feb 2006)
  • 4. Examples not covered: paternity determination and legal purposes
  • 5.  No self-certification for genetic testing essential to medical practice
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From 13485 to the IVDD
  • IVDD update
  • - Life Sciences and Biotechnology
  • 1.  Commission report COM(2005) 286 final dated 29.06.2005
  • 2.  Refocusing the “Lisbon strategy, Agenda 21” to sustainable development
  • 3.  Proposal to budget 4.2 billion Euro for developing European biotech industry (2007à2013)
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From 13485 to the IVDD
  • IVDD update
  • -  Life Sciences and Biotechnology
  • 4. Maintain competitiveness with US and Asia-Pacific
  • 5.  Biotechnology Advisory Group (CBAG) main vehicle
  • 6.  98/44/EC on legal protection of biotech inventions in member states
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From 13485 to the IVDD
  • IVDD update
  • -  Life Sciences and Biotechnology
  • 7.  New regulatory framework for pending decisions on Genetically Modified Organisms (GMOs)
  • 8.  Emerging issues: tissue engineering and pharmacogenetics
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From 13485 to the IVDD
  • Thank you!
  • Lew Farris
  • Medical Lead Auditor
  • Medical Division, Pleasanton Office
  • 1279 Quarry Ln., Ste. A
  • Pleasanton, CA  94566
  • P: (925) 249 - 9123 Ext. 113
  • F: (925) 249 - 9124
  • Email: lfarrris@us.tuv.com
  • Web Address: http://www.tuv.com