| REGULATORY STANDARDS | ANALYSIS
reaction of MHRA Chief Executive Professor Sir Kent Woods, who vowed 'to act quickly to implement the recommendations and use the lessons learned to improve the regulatory system for medical devices in the UK and Europe'. A second, more in-depth review of
cosmetic surgery regulation in the UK is being authored by NHS Medical Director Professor Sir Bruce Keogh, and is targeted for release in March 2013. It will look at whether the cosmetic surgery industry needs to be more effectively regulated. No direct blame has been attributed to
the MHRA, which was found to its job, but could these two studies have been commission before the crisis ® which had been brewing for a number of years ® reached its peak? Possibly, but the conclusions might have been weak, reached with little conviction or subsequently insufficiently followed through. In contrast, certain reactions since the crisis have been strong and decisive.
In Germany, for instance, the
authorities have recently been given greater powers to police manufacturers, including the ability to make unannounced visits to manufacturersÕ premises. On 30 March 2012, the German upper house passed the Allgemeine Verwaltungsvorschrift zur Durchf• hrung des Medizinproduktegesetzes (MPGVwV), a law that allows the authorities to intervene in cases of suspected medical device fraud, for instance. The law will come into force on 1 January 2013.
Tighter controls needed Notified bodies (NBs) have been criticised as being too variable in their performance, generally, and too numerous. Improved surveillance of device product safety will be taken up in the forthcoming EU medical devices directives review, due in autumn 2012, which is likely to introduce comprehensive supervision of NBs, often in the past identified as the 'weak
link' in the EUÕs 'new approach' to medical device legislation. Many feel that in order to retain the
largely successful 'non-prescriptive' risk-based system of medical device (and breast implant) regulation, NBs must be seen to be more tightly controlled. In France, where the PIP scandal
originated, support for the EU medical device directives remains strong, even though in January 2012 the then health minister, Xavier Bertrand, spoke in favour of a pre-market authorisation (AMM) for implants. The Mediator scandal in 2011, when insufficient oversight of off-label use of the Servier drug as an appetite suppressant led to hundreds of deaths from heart valve insufficiency, saw the regulatory agency, Afssaps, reformed and renamed (as ANSM). But an AMM for implants ® as proposed
by the European ParliamentÕs Committee on Environment, Public Health, and Food Safety (ENVI), and endorsed by the European Parliament (EP) on 13 June,
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