July 9, 2012
By John Brennan, Director of Regulatory and Technical Affairs, Eucomed
Last month I wrote a blog on pre-market authorisation (and why this approach does not work for devices!) and thought it would be a good idea to just lay out how the European approval process for medical devices actually works. It might be a bit ‘dry’ but at least after reading this post you’ll understand the mechanics of the European system.
Authorities set the legal safety and performance requirements to be met by manufacturers for their products. These are laid down in the ‘Essential Requirements’ of the medical devices Directives. They complement this with detailed Harmonised European Standards covering not only the products themselves but also the materials they’re made of and the tests they must pass, including standards on clinical investigations. There are also standards on how the devices must be controlled during their design and manufacture including cleanliness and sterility.
These standards are thus available to doctors, manufacturers and notified bodies alike to help determine safety and are the subject of continuous update to keep pace with the latest in science and technology. In addition there is a formal mechanism for authorities or the European Commission to intervene and de-list or augment a standard should there be a safety concern…