The Medical Device Directive  is clearly getting ‘long-in-the-tooth’. Product development by the Industry has progressed immeasurably over the last 20 years since its first publication in the EU’s Official Journal to now include technologies such as nanotechnologies, stand-alone software, tissue engineering and micro-electronics to name but four.
Despite the revision  in 2007, the current regulatory scheme is coming under increasing strain, as the CE Mark originally intended for traditional devices such as dressings and implants, struggles to include these new technologies.
At the same time that technology development accelerates, so has the public perception and understanding of medical devices. The surgeon, nurse and patient have more product related information at his or her fingertips through the Internet, newspapers and published literature, than ever before.
Because of recognition of these misgivings, steps were initiated by the European Commission more than two years ago, to consider what the new iteration of the Medical Device Directive should look like, resulting in the proposal for regulation 2012/0266 (COD), published in September 2012 . Events of 2012 however, particularly the scandal involving PIP breast implants  and ‘Metal-on-Metal’ partial hip replacements  have accelerated these plans.
But what do these changes include and what do they mean to the Medical Device manufacturer?
Although there are many changes within the new proposed revisions, the fundamental ‘New Approach’ for the regulation of medical devices remains. This therefore means that the principles of Essential Requirements, harmonised standards, Conformity Assessment and Company ‘Declarations of Conformity’, are not going to give way to more prescriptive pharmaceutical style regulation and licensing.
Having said this, the Governmental and public clamour for resolution to the 2012 scandals, has resulted in some aspects appearing to take on a more pharmaceutical feel, as well as ensuring that some features of the revisions are to be fast-tracked for approval.
This short paper only highlights those areas earmarked for revision within the medical device directive that are currently occupying most discussion space within Trade Association and European Commission communications. These discussions are ongoing, but timelines suggest that some items, such as Distribution, Post-Marketing Surveillance requirements and Notified Body controls have more priority over the other points and could well be enforced within the next 12 to 18 months.
The next paper in this short series will concentrate on the Authorised Representative and Economic Operators and their role in improving traceability and post-market surveillance.
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 Council Directive 93/42/EEC of 14 June 1993, concerning Medical Devices (OJ L 169, 12.7.1993, p1)
 Council Directive 2007/47/EC of 5 September 2007, amending … Directive 93/42/EEC