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TÜV Rheinland PTL

FDA Compliance

Event: Are You Ready for the Changes to the Medical Device Directive?

Staying competitive in the global market

Published: Monday, March 1, 2010 - 11:13

(TÜVRheinland, Newtown, CT) -- Starting March 21, all medical device manufacturers must comply with the Directive 2007/47/EC or risk being pulled from the European Community’s marketplace. TÜVRheinland and the Washington State Department of Commerce are offering a half-day seminar about the amendments to the medical device directive as a result of the new directive.

The educational event called  “Changes to the Medical Device Directive: Staying Competitive in the Global Market” will take place Friday, March 12, from 12–4 p.m. at the University of Washington-Bothell, 18115 Campus Way NE, Bothel, Washington, in The Rose Room (280) UW1 Building. The event includes a panel discussion with Washington State’s overseas representatives as well as a networking reception.

At the seminar, 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), and the Biocidal Product Directive (98/8/EC).

The seminar will summarize the new Directive 2007/47/EC and its effect on all previously classified medical devices. Additionally, the agenda will include the medical device directive’s:

  • New definitions
  • Extended scope
  • Classification changes
  • Essential requirement changes
  • Required clinical data evaluation
  • Process for Conformity Assessment
  • Recommendations for implementation

Following the educational seminar, attendees can meet Washington State Europe and China Office representatives who will explain market opportunities and how they can help Washington companies enter their markets. A networking reception will follow.

Individuals involved in regulatory affairs and compliance, research and development, imports/exports, sales, and product marketing are encouraged to attend. The cost to attend is $150. The Washington State Department of Commerce is offering a $50 scholarship for the first 20 individuals who register.

To register, call TÜVRheinland at (888) 743-4652. For more information about location contact June Chino at june.chino@commerce.wa.gov or (206) 256-6144



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TÜV Rheinland PTL

TÜV Rheinland Photovoltaic Testing Laboratory (PTL) LLC is a world-renowned facility for photovoltaic (PV) technology testing located in Tempe, Arizona, USA. TÜV Rheinland PTL is a partnership between the TÜVRheinland, a $1.5 billion USD provider of independent testing, assessment, and certification services for industry; and Arizona State University (ASU), one of the leading research and educational institutions in the USA. Locally, the ASU’s photovoltaic have been providing testing services to the photovoltaic (solar) power marketplace since 1992. TÜV Rheinland PTL, is an ISO 17025-accredited facility by the American Association for Laboratory Accreditation (A2LA).