European Medical Device Regulations: Implications for Orally Inhaled and Nasal Drug Products
Donawa ME.
RDD Europe 2017. Volume 1, 2017: 87-94.
Abstract:
A new European medical device regulation is expected to come into effect in the second quarter of 2017, with a three-year transition period. Transitional arrangements will allow certain devices to remain on the market for a specified period of time beyond the end of the transition period. However, manufacturers who have placed devices on the European market or are planning to do so, will face a new set of requirements including, for manufacturers of non-active inhalation devices, the establishment of a partial or full quality management system and contracting with a Notified Body, which will be responsible for evaluating device technical documentation and company quality management systems, and issuing certificates that are needed to comply with the CE marking process. New requirements will also apply to manufacturers of active inhalation devices. There will also be a new in vitro diagnostic medical device regulation, which will have a five year transition period, but will not be further discussed.
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