Medical Device Directive

Key Facts:

• After May 26, 2020 the Medical Device Directive will be fully replaced by the Medical Device Regulation
• MDD I manufacturers and MDD I(s/m), IIa, IIb or III who do not already possess a CE Certificate with an expiration date beyond May 26, 2020 are obligated to comply by this deadline
• EUDAMED is scheduled to become operational for Notification per the MDR by March 2020

Learn More:

• Scope
• Classification
• The Directive: MDD 93/42/EEC
• Technical File
• Notified Body under the MDD
• Authorized Representatives under the MDD
• Custom Made Medical Devices
• Clinical Investigation
• Kits
• Risks of Non-Compliance

With the Medical Device Regulation transition well underway, be sure to learn about the upgraded requirements in order to comply by the May 2020 deadline.