The Medical Device Directive Recast

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Course Outline

The much talked about “Recast” of the Medical Devices Directives has caused a great stir within the medical devices industry. This will be another sweeping change proposed by the European Commission in an approach to raise the standard bar, tighten the requirements and establish a robust regulatory system to ensure safety, quality and efficacy of medical devices.

A great deal of trade press coverage has given many snippets of information, views and opinions. Some of this has been good information; some misinformation; and some just plain opinion. For the industry many have been left wondering what the changes actually are, what the impact of the changes will be and when it is all going to happen.

This essential course is intended to give you the latest and best information regarding the developments of these changing regulatory requirements including those from a Notified Body perspective as a guest speaker. The course will highlight the key areas of significant changes, and how to ensure ongoing compliance together with the timetable for change all in the context of the current regulations that are the 3 Medical Device Directives. We will debunk the myths, hearsay and ill-informed opinion and in a highly practical and pragmatic course will convey what the Recast will mean to you in practical terms.

Topics covered

• Brief history of the 3 Medical Device Directives
  • 93/42/EEC – The Medical Devices Directive
  • 98/79/EC – The In Vitro Diagnostic Medical Device Directive
  • 90/385/EEC – The Active Implantable Medical Device Directive
• The proposed merging of the Directives 93/42/EC and 90/385/EEC
• The proposed changes to the current Directives to transform them into Regulations including, amongst other highlights
  • Single use devices and reprocessing
  • New rules on Invasive or implantable devices without a medical purpose
  • Proposed Medical Device Qualified Person’s role
  • Re-classification of some devices
  • Increased traceability with UDI and enhanced Vigilance System
• The role of industry lobby advocacy groups (ABHI and EUCOMED)
  • Latest Position Statements
• Notified Bodies Perspective
  • New mandates
  • Unannounced visits
• Competent Authorities
  • Recommendations on how the Competent Authorities are to operate
• An understanding of the new requirements due to the Recast
• Awareness of the impact of the changes
• Practical solutions to staying complaint
• Understand the role of regulatory bodies under the new changes

Outcomes

• An understanding of the new requirements due to the Recast
• Awareness of the impact of the changes
• Practical solutions to staying complaint
• Understand the role of regulatory bodies under the new changes