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Recast Medical Device directives Impacts on materiovigilance

 Journee Vigilance
Description: Stricter pre-market control of high-risk devices with the involvement of a pool of experts at EU level. The inclusion of certain aesthetic devices within the scope. Reinforced designation and oversight processes of notified bodies. Reinforcement of the rules on clinical evaluation (and performance evaluation) and clinical investigation (and performance studies) Stricter rules for "substance-based" devices. New classification system for IVDs based on international guidance (80% of IVDs to be assessed by a Notified Body) Stricter requirements related to the use of hazardous substances for certain devices Introduction of a UDI system.
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Domain: Medical
Category: Equipment
Contributing Organization: FAMHP
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Recast Medical Device directives
Impacts on materiovigilance
Journée Vigilance


Valérie Nys

Revision of the EU Medical Devices Legislation

• Directive 90/385/EEC on active implantable medical
• Directive 93/42/EEC on medical devices

Regulation on medical devices
• Directive 98/79/EC on in vitro diagnostic medical
Regulation on in vitro d ... See more

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