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How Will Directive 2007/47/EC Affect Medical Device Exports to the EU?
Starting March 21, 2010, all medical device manufacturers must comply with the Directive 2007/47/EC or risk being pulled from the EC market. Manufacturers can learn more about the Medical Device Directive at a seminar hosted by TÜVRheinland.
The educational event called “Are You Ready for the Changes to the Medical Device Directive” will take place in five locations across the United States: Irvine, Calif; San Francisco, Calif; Shoreview, Minn.; Tampa Bay, Fla.; and Waltham, Mass. TÜVRheinland will explain the changes to the Directive 2007/47/EC, which amends sections of the Medical Device Directive (93/42/EEC), the Active Implantable Medical Device Directive (90/385/EEC)
The seminar will summarize the new directive, its effect on all previously classified medical devices. Additionally, the agenda will also include the Medical Device Directive’s:
o New definitions
o Extended scope
o Classification changes
o Essential requirement changes
o Required clinical data evaluation
o Process for Conformity Assessment
o Recommendations for implementation
The TÜVRheinland seminars are taking place on the following dates and locations:
o January 26, Waltham, Mass.
o February 2, San Francisco, Calif.
o February 3, Irvine, Calif.
o March 2, Shoreview, Minn.
o March 4, Tampa Bay, Fla.
Individuals involved in regulatory affairs and compliance, research and development, imports/exports, sales, and product marketing are encouraged to attend. Cost to attend is $199.
To register or receive more information about the seminar, call 1-TUV-RHEINLAND (888-743-4652)
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