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.
4:00 p.m. CET
3:00 p.m. GMT
11:00 a.m. EST
11:00 p.m. CST (China)
For more information or questions, please contact us at email@example.com.
Please join the following speakers for this timely one-hour webinar on these and related developments.
Director Regulations and Industrial Policy
Partner - EU Life Sciences Regulatory, Compliance and Enforcement
Sidley Austin LLP,
Sidley Austin LLP is a State Bar of California approved MCLE provider, as well as a New York Accredited provider of NY CLE credit, an Illinois Accredited provider of IL CLE credit, and an approved sponsor of Texas CLE credit. CLE credit is pending for this program.