Revision to the Medical Device Directives

The revision to the Medical Device Directives is being implemented across the EU. This seminar will examine the changes and their impact on the Medical Device industry including: Reclassification, Clinical Data, Performance of Notified Bodies, Vigilance, PMS and Risk Management. In addition the Revision of ‘New Approach’ Legislation will be discussed. This will be an excellent opportunity to understand the implications of the regulatory changes and how they will affect working practices. There will also be an introduction to the Commission’s consultation relating to the recasting of the medical device directives.