2011: The Year That Was The major European medical device regulatory developments of 2011 provide

2011: The Year That Was

The major European medical device regulatory developments of 2011 provide a good indication of where the E.U. Commission will direct its efforts in 2012. As Emergo Group has previously reported in this column, improving Europe’s Notified Body system received lots of attention last year—not only from regulators, but also from the Notified Bodies themselves. Regulators have hinted strongly that a revamped Notified Body system will be included in any revision of the Medical Device Directives, and Notified Bodies in turn published their own voluntary code of conduct in 2011 to demonstrate good-faith effort to improve their performance. Whether Notified Bodies’ code of conduct will allay regulators’ concerns or be discarded in favor of more rigorous E.U. requirements remains to be seen, but could be resolved this year.

The E.U. Commission also indicated in late 2011 that it is considering revising the Medical Device Directives as regulations rather than directives. Such a move would obviate the need for transposition by each E.U. member state. However, taking a regulatory tack would open the revision process to significant scrutiny by the European Parliament and the E.U. Council. This approach may help avoid many of the current regulatory inconsistencies across member states that have arisen from differences in national transpositions of the existing directives. Either way, there will be no short cut to reform.