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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.
years of successful work