The European medical device regulatory and enforcement environment has changed significantly since 2012. National Competent Authorities have increased their surveillance and enforcement activities, and Notified Bodies are under increasing pressure with respect to their monitoring of industry. As a result, manufacturers are forced to adjust to a new level of scrutiny and face (often unexpected) major challenges in different areas, including with respect to vigilance reporting obligations, certification of new products and renewals of existing certificates. In parallel, the EU Institutions continue to discuss the two Regulations intended to replace the existing EU legal framework.
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Director Regulations and Industrial Policy
Partner - EU Life Sciences Regulatory, Compliance and Enforcement
Sidley Austin LLP,
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