How and when will you be affected?
The existing legislation, consisting of three European directives, was originally drafted 20 years ago. Although there have been numerous amendments over this span of time, the original directives have gone mainly unrevised. During this time the number of member states within the European Union has increased and technology has improved and become more complex. In order to maintain the safety and efficacy of higher technology devices which may carry a greater risk to users and patients, the regulations governing the market approval for these devices must evolve. The catalyst for this fervent push to revise the European directives stems from the Poly Implant Prothèse (PIP) breast implant scandal. PIP, a manufacturer of silicone breast implants, was found to be using dangerous “homemade” silicone filler made from industrial silicone.
So the question on the table now is how and to what extent should the system be revised? Based upon how this situation developed, making sure safe and effective devices are marketed throughout the EU is a high, if not the first, priority. Unsafe devices need to be identified both quickly and efficiently and kept from being sold in the marketplace.
Download your copy of “The debate over changing the EU Medical Device Law, How and when will you be affected?” now and learn more about what changes are being proposed, the ensuing debate, when can we expect approved changes to be enforced, and what are the language and translation implications.