Updated Medical Device Regulations for the European Union | Page 5
Figure 5. Need
for Updated Directives 12, 18
problems that should be addressed in any new legislation:12,18
Post-market safety
Regulatory status of products
Lack of transparency and harmonized traceability
Access to external expertise
of economic
12
Management of the regulatory system
Key elements include:
• Wider and clearer scope
Proposed Legislation »
• Stronger supervision
clinipace.com
4