Review of the Regulation & Proposed Changes

• Scope & EC Agencies

• Definitions

• Classification Rules

• Conformity Assessment Routings

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

  • Class II a

  • Class II b

  • Class III

• Procedure Packs

• Clinical Evaluations

  • Clinical Data

  • Clinical Investigations

• Notified Bodies

• CE Marking

• Post Market Surveillance & Reporting

• Proposed changes to the Directive

Essential Requirements

• General Requirements

  • Safety & Performance

  • Risk Management

• Chemical Physical & Biological Properties

• Design & Construction

• Infection & Microbial Contamination

• Construction & Environmental Properties

• Devices with a measuring Function

• Protection against Radiation

• Requirements for Devices connected to or equipped with an energy source

• Information Supplied by the Manufacturer

  • Information

  • Label

  • Instructions for Use

• Clinical Data