How Will Directive 2007/47/EC Affect Medical Device Exports to the EU?

PRLog (Press Release) - Dec. 21, 2009 - NEWTOWN, CT/ — Starting March 21, 2010, all medical device manufacturers must comply with the Directive 2007/47/EC or risk being pulled from the EC market.  Medical device manufacturers can learn more about the Medical Device Directive at a half-day seminar hosted by TÜVRheinland®, the world leader in independent testing and certification services.

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

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).

About TÜVRheinland®

TÜVRheinland® delivers premier independent testing, assessment, and certification services to help companies gain access into global markets. Boasting an international network across six continents, the company’s in-country experts ease the path to compliance with cost-effective pricing and quick turnaround times. The $1.5 billion corporation is comprised of an international network of more than 13,300 employees in 61 countries and serves most industry sectors and markets worldwide. For more information, visit www.us.TÜV .com.

# # #

TÜVRheinland® delivers premier independent testing, assessment, and certification services to help companies gain access into global markets.