 |
How To Implement the New European Vigilance Procedures |
| Major postmarketing vigilance revisions are now in force:
A revised medical device guidance document on postmarketing vigilance (MEDDEV 2.12-1 rev 5) was published in April 2007 by the European Commission. This new guideline came into force on 1 January 2008 after a nine-month transitional period to allow manufacturers, distributors and authorised representatives time to implement the necessary revisions to their operating procedures. The 2007 update provides significantly more guidance than the previous 2001 version and includes new reporting terminology and concepts such as “periodic summary reporting” and “trend reporting.” In addition, the terms “advisory notice,” “near incident” and “recall” have been eliminated or replaced. Although MEDDEVs are not legally binding, it is likely that all European Competent Authorities will follow the new guidelines and will expect organisations involved in the management and reporting of adverse incidents to follow them as well.
This webinar will cover all the major revisions, point by point, including:
- New terms and definitions
- Extended scope
- Reporting criteria and timelines
- Filed safety notices and field safety corrective action
- Periodic reporting
- Vigilance aspects of revising Directive 2007/47/EC
- Roles of the Competent Authorities, European Commission, Notified Bodies and users.
|
Web Event:
|
How To Implement the New European Vigilance Procedures |
| Date: |
April 2, 2008 |
| Time: |
10:00 a.m.
London
11:00 a.m. Paris
|
| Duration: |
60 minutes |
| Who should attend: |
Regulatory and quality management personnel involved in device manufacture or distribution. |
|
Speaker:
Roger Gray, BSc, CEng, MIMechE, Director, Global Regulatory Affairs, Donawa Consulting, Rome, Italy Roger Gray is Director, Global Regulatory Affairs at Donawa Consulting, where he is responsible for helping clients obtain medical device marketing clearance for Europe and the USA, in addition to managing the company's European Authorised Representative portfolio. He has over 25 years' experience in the medical device industry and, as chair of the Association of British Healthcare Industries Technical Committee and a member of the COCIR Technical Committee, was closely involved with the development of the Medical Devices Directive during its formative stages. With a degree in mechanical engineering, he worked in military research, automotive R&D and technical consulting before joining the medical device industry.
|
|
Moderator:
Annie Ellerton , Editor in Chief, Medical Device Technology |
|
TO REGISTER
FOR THIS EVENT CLICK HERE
|
|
|
|
©2008 Canon Communications LLC
Canon Communications LLC
11444 W. Olympic Blvd.
Los Angeles, CA 90064
|
|
