Updated Medical Device Regulations for the European Union | Page 7

Parliamentary Review »

Figure 7. Proposed
Legislation: Risk Class
Breakdown of Medical
Devices and Active Implantable Medical Devices 13, 18

Figure 8. Proposed
Legislation: Risk
Class Breakdown of
In Vitro Diagnostic
Medical Devices 18

21

22

It is important to note that the Commission did not recommend the creation of a centralized medical device agency similar to
the EMA for pharmaceuticals. In fact, the proposed legislation argues against a centralized system because of the enormous
of the PIP breast implant scandal in which the manufacturer stopped using medical-grade silicon after the product received a
CE marking. The Commission emphasizes that a centralized system would not have prevented this deliberate fraud and instead
suggests that the event reinforced the need for post-marketing safety assessments.12

clinipace.com

6