EU Medical Devices Regulation – CE Mark Expiration and the EU Refusal of Your Exports

FDA and the EU have tried to harmonize device regulatory requirements for over 25 years. Major differences between FDA and the EU include premarket authorization (CE Mark), complaint investigations, postmarket surveillance and reports. The EU’s new Medical Devices Regulation (MDR) incorporates more rigorous regulatory requirements for those areas and in some cases outpaces the FDA’s requirements. The FDA gold standard may take a back seat. Corporations, manufacturers, distributors, importers and Notified Bodies now have specific requirements that must be met in order to market products with a CE mark. The requirements are more extensive than FDA’s in critical areas. This means you need to upgrade and implement your Quality System regulation program before 2020.

Why You Should Attend:

The webinar will cover an overview of the changes in the EU’s device regulatory requirements. Compliance is required. Firms may be dismayed at the new requirements. The economic burden will be significant. A CE mark may be withdrawn for currently marketed devices that have predicates relying on technology over ten years. Devices that do not meet the new CE mark requirements are subject to refusal by the foreign country and therefore do not meet FDA’s legal requirements for export status. This means your device has no market in the EU and will not be permitted back into the U.S.

Firms need to review their FDA regulatory program to identify where some requirements may need to be revised so device design, production, CAPA and the use of a Total Product Life Cycle Paradigm conform to FDA’s and the EU’s requirements.

The topics of the webinar will include the following:

• How their products are now defined under MDR
• New compliance requirements
• The impact of new CE mark qualification
• Legal impact on U.S. exports

Areas Covered in the Session :

• Identify the significant MDR requirements that apply
• Benefit/Risk analysis
• Understand “Substantial Equivalence” for premarket authorization
• Highlight postmarket requirements for reports, procedures and records
• Identify the U.S. Export consequences

Who Should Attend:

• Device Manufacturers
• Quality Assurance Mangers and Consultants
• Regulatory Affairs Directors
• Regulatory Program and Procedures Developers
• International Logistics Manager (Export/Import)
• Three-year business plan developers
• Device design / specification developers
• Forensic Engineers
• Post-market surveillance managers

Course Director: CASPER E. ULDRIKS ‎

Casper (Cap) Uldriks brings over 32 years of experience from the FDA. He specialized in the FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and as an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. He is recognized as an exceptional and energetic speaker. His comments are candid, straightforward and of practical value. He understands how FDA thinks, operates and where it is headed. Cap is the President of Encore Insight LLC, a consulting and training service for FDA law and operations.