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.
Become MDlaw member