MEDDEV guidance on Clinical Evaluations has been updated (MEDDEV 2.7.1 rev. 4). The guidance is clearly more extencive than previously, but includes also guiding how to apply it. Notified Bodies, in our experience, are getting more active on this.
The European device regulation is changing! The European Parliament has approved the new regulation regarding medical devices and IVD devices on May 4th 2017. As the European Council has accepted regulations earliert, these will come into effect presumably by June. The transition period on medical devices is 3 years and on IVD devices 5 years.
New regulations are to modernize and strengthen legislation, to improve market surveillance and traceability, and to ensure that the design of all medical devices and IVD devices take into account the latest scientific and technical developments. The objective of the new regulation is to: