EMDT_European Medical Device Technology

European Medical Device Technology, Spring 2014

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42 | Spring 2014 European Medical Device Technology emdt.co.uk special report How to Survive an Unannounced In the wake of the PIP debacle, Notified Bodies will be cracking down on day-to-day compliance by way of unannounced audits. But what does this mean for medical device manufacturers? F ew companies can claim to have had as significant an impact on the medical device industry as Poly Implant Prothèse (PIP). The now-notorious PIP breast implant scandal, in which the French firm fraudulently employed industrial-grade silicone instead of medical-grade silicone in an effort to boost profits, cast a long shadow over the medical device industry and spurred demands for sweeping regulatory reform across the European Union. Among the first changes to go into effect is the rollout of manda- tory unannounced audits by Notified Bodies. While unquestionably daunting for medical device manufacturers, these surprise inspec- tions are intended to promote quality and patient safety. In short, EU authorities want to nip quality problems in the bud and prevent another PIP fiasco. So, how can manufacturers adequately prepare to ensure that their unannounced inspection goes smoothly and they don't encoun- ter any additional unwelcome surprises? What to Expect Although unannounced audits have always loomed as a possibility for European medical device manufacturers, they were typically only carried out in response to a specific trigger or safety concern. Following the European Commission's recommendation in Septem- ber, however, Notified Bodies must now perform regular unan- nounced audits of all manufacturers, regardless of location, that sell medical devices to the European market. "Notified Bodies should carry out unannounced audits at least once every third year," according to the recommendations. "Noti- fied Bodies should increase the frequency of unannounced audits if the devices bear a high risk, if the devices of the type in question are frequently noncompliant or if specific information provides reasons to suspect nonconformities of the devices or of their manu- facturer." Two auditors will typically perform an unannounced inspection in one day; companies with many products will take longer, however. And, yes, unannounced truly means unannounced. The Notified Body Dekra's policy, for example, is to call 10 minutes in advance with the audit to officially begin within 30 minutes of arrival, Chris Sarner, project manager of medical device certification for Dekra, noted during a recent presentation at the MD&M West conference in California. Other Notified Bodies maintain that they will show up on a manufacturer's doorstep with no warning whatsoever. "Usually audits, when done, are very effective when the manu- facturer has time to prepare; all people who have knowledge of the processes are there, the manufacturer can be organized, etc.," says Peter Havel, senior vice president of medical & health services, TÜV SÜD. "But the intention of the EU Commission is to ensure continuous compliance with quality management requirements. The EU suspects that the level of compliance demonstrated during an audit might not have accurately represented realistic day-to-day compliance." Shana Leonard ES430781_EMDT1405_042.pgs 04.29.2014 03:28 UBM black yellow magenta cyan

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