How the Medical Device Industry Can Stay Competitive Globally

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:

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