How the Medical Device Industry Can Stay Competitive Globally

PRLog (Press Release) - Feb. 25, 2010 - SEATTLE, WA and 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®, the worldwide leader in global market access, 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 “Are You Ready for the Changes to the Medical Device Directive” will take place Friday, March 12 from 12 – 4 p.m. at the University of Washington Bothell, 18115 Campus Way NE, 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:

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

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 1-TUV-RHEINLAND (1-888-743-4652), or, for more information, contact June Chino at (206) 256-6144 or june.chino@commerce.wa.gov.

About Washington State Department of Commerce
   
Washington State Department of Commerce’s mission is to grow and improve jobs in the State of Washington. The International Trade & Economic Development Division assists Washington state’s small and medium sized businesses to expand and also to attract companies from around the world in industries such as aerospace, clean technology, forest products, global health/life sciences, information & communication technology, and manufacturing. Through Washington State China (also covering India, Thailand, and Vietnam), Europe (coverage in about 20 EU countries), Japan, Mexico, and Taiwan Offices, companies can increase their export sales through free governmental assistance such as business matchmaking, trade show support, advocacy, market intelligence etc.  For more information, visit www.choosewashington.com

About TÜVRheinland®

TÜVRheinland® is the worldwide leader in market access, helping businesses gain international approvals in more than 200 countries. The company delivers premier independent certification, testing, and assessment services for many industry sectors.  With in-country experts across six continents, TÜVRheinland eases the path to compliance with technical expertise, 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. 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.