Delivering in-house training in the Medical Device Directive. Call Rachel McLean +44(0)1292 671555

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MEDICAL DEVICE DIRECTIVE

One Day Awareness Workshop Contents
This workshop requires an appreciation of Directive 93/42/EEC of 14 June 1993 concerning medical devices, [commonly termed the Medical Device Directive (MDD)], and is designed for delegates who wish to gain knowledge of the key aspects. The key topics covered include all the chages to the MDD since 1993 and include:

 

  • Scope & EC Agencies

  • Definitions

  • Classification Rules

    • Class I

    • Class II a

    • Class II b

    • Class III

  • Conformity Assessment Routings

    • Class I

    • Class I Sterile and/or with measuring function(s)

    • Class II a

    • Class II b

    • Class III

 

  • Procedure Packs

  • Clinical Evaluations

    • Clinical Data

    • Clinical Investigations

  • Essential Requirements

    • Summary

  • Notified Bodies

    • Responsibilities

  • CE Marking

    • Restrictions

  • Post Market Surveillance & Reporting

  • Planned changes to the Directive

 

Call Rachel McLean on +44(0)1292 671555 or email rachel@gpb.ltd.uk to discuss your needs.

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