European Medical Device Technology (EMDT)
Published: October 25, 2012
By: Maria Donawa
On 26 September 2012, the European Commission adopted a “package on innovation in health” consisting of the “Communication on safe, effective and innovative medical devices and in vitro diagnostic medical devices for the benefit of patients, consumers and healthcare professionals”1, a proposal for the regulation of medical devices2 and a proposal for the regulation of in vitro diagnostic (IVD) medical devices.3 The proposed medical device regulation will cover in one regulation devices that are currently the subject of two separate directives, the Active Implantable Medical Devices Directive (AIMDD; 90/385/EEC) and Medical Devices Directive (MDD; 93/42/EEC). The use of regulations instead of directives is important because regulations are directly in force across all countries in the European Union (EU), whereas directives must be transposed into national law in each member state. The transposition process led to variations in national implementation of the directives, which should be avoided by the use of regulations.
It is not surprising that the medical device proposal reflects a more stringent approach to European device regulation; however, the number and level of stringency of some of the proposed provisions is surprising and in some cases perplexing. Of course, important changes could still be made before it is published as a final regulation, which is expected to be during 2014. In any case, readers are strongly encouraged to thoroughly review the proposal to gain a general understanding of the depth and range of the proposed revisions. This will take time because the entire proposal is 194 pages and includes 13 pages of an explanatory memorandum, 13 pages of recitals (“whereas” statements), 73 pages containing 97 articles, 75 pages containing 16 annexes, and a 20-page legislative financial statement. This article provides only an introduction to the proposed regulation; future articles will discuss some of the proposed revisions in more detail…