1 / 6

ABHI Code of Business Practice

ABHI Code of Business Practice. Mike Kreuzer Director Technical & Regulatory - ABHI. International Medical Device Compliance Congress Paris May 2008’. ABHI Code of Business Practice. In 2005 ABHI ‘recommended’ that members adhere to the EUCOMED Code of Practice

tosca
Download Presentation

ABHI Code of Business Practice

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. ABHI Code of Business Practice Mike Kreuzer Director Technical & Regulatory - ABHI International Medical Device Compliance Congress Paris May 2008’

  2. ABHI Code of Business Practice • In 2005 ABHI ‘recommended’ that members adhere to the EUCOMED Code of Practice • It was assumed that enforcement was EUCOMED’s responsibility • The issue was extensively debated in EUCOMED in 2006 • 2007: the need for a ABHI complaints adjudication procedure was accepted • Adherence to the Eucomed CoBP is now a condition of ABHI membership International Medical Device Compliance Congress Paris May 2008’

  3. Proposed Way Forward for ABHI • UK favours self-regulation • Two existing enforcement models were considered • SDMA costs c.£ 1-3k pa – PMCPA c.£750k • ABHI needs to start modestly using SDMA model • BUT with one significant change • Panel must be fully INDEPENDENT International Medical Device Compliance Congress Paris May 2008’

  4. Panel of Experts • Panel chair should have a legal background • Independent panellists to be recruited e.g. HCPs • ABHI DG or nominee on panel as observer • Panellists to be chosen by ABHI Council International Medical Device Compliance Congress Paris May 2008’

  5. Complaints Process • Panel to clarify and interpret • Will not have investigative powers • No appeal process (cost) International Medical Device Compliance Congress Paris May 2008’

  6. Other Considerations International Dimension • There will be cross-border issues • Eucomed MUST put their own enforcement in place • This should evolve into an appeals mechanism International Medical Device Compliance Congress Paris May 2008’

More Related