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 A CE mark may be withdrawn for currently marketed devices that have predicates relying on technology over ten years.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