This week my inbox was flooded by notifications of a great blog post from the Emergo group, outlining the changes set to occur to the medical device regulations in Europe. Changes such as:
- Much of European Guidance and GHTF Guidance will become mandatory;
- Addition of "Qualified Persons" at manufacturers / authorized representatives;
- Additional definitions;
- Expansion of notified body requirements and activities, including unannounced inspections; and
- Increased reviewers for Notified body applications, and Class III applications for CE Marking.
Emergo has embedded their white paper with an in-depth analysis of the changes in the post. All manufacturers marketing and selling in Europe need to review these changes and make decisions on their impact to their business and products. Management review anyone?