Most interestingly, Minor revealed that the EU Commission was considering regulations—one

Most interestingly, Minor revealed that the EU Commission was considering regulations—one for medical devices and active implantable devices, and another for in vitro diagnostic devices (IVDs)—rather than directives as part of its revision effort. The significance of this distinction is that a regulation would go into effect across all EU member states as written, with no transposition by national authorities. Directives, on the other hand, require transposition on the national level, making EU harmonization of medical device market requirements harder to achieve. Some critics now contend that the EU harmonization of the medical devices sector has been plagued by differences in national transpositions of the Medical Devices Directives. As an example, to deal with the divergent national interpretations of the Cosmetics Directives’ national transpositions, the cosmetic products legislation was promulgated as a Cosmetics Regulation.

A potential difficulty in adopting regulations rather than directives, however, is that every aspect of a regulation would be subject to inspection and scrutiny by the European Parliament and EU Council. Had the directives been recast, only the topics that were subjected to revision would be discussed.

According to Minor, the EU Commission has completed its impact assessment of proposed Medical Devices Directiverevisions—a prerequisite of any newinitiative in the European Union. Minor and other EU Commission sources have indicated that publication of draft regulations (as well as release of the Impact Assessment) will happen in April or May of next year.