Due to the recent Poly Implant Prothese fraud case where executives went to trial accused of supplying women with hundreds of thousands of substandard breast implants, the medical device industry agreed that an overhaul of Europe’s regulatory framework is necessary to improve the system without compromising safety.
The European Parliament committee has voted for stricter regulations including tougher conformity assessment bodies, a new system for labeling medical devices and a new body to review potentially high risk devices.
Eucomed, the European medical technology industry association has welcomed most of the recommended changes in the new regulations but also voiced concerns about the authorization system. Their concerns about the authorization system could make patients wait an extra three to five years before receiving lifesaving medical treatment. The new regulatory burden could also have a negative impact on small and medium-sized companies in the Medical device industry.
The Parliament will vote on the draft law during the October 21 – 24, 2013 session in Strasbourg, France.