We provide weekly updates about regulations and guidelines in the European Medical Device and In-Vitro Diagnositc Industry.
New EUDAMED roadmap, Call to action for Class D IVDR Manufacturers
Dear Reader
Please find below the latest regulatory news in Europe.
New EUDAMED roadmap (Draft):
The EU Commission has published a Draft EUDAMED Roadmap with updated timelines.
These are the following changes:
- Mandatory use of the modules Actor, Certificates, MSU, Vigilances, CI/PS by Q4 2027 as per EU MDR article 123(3)(d) and EU IVDR article 113(3)(f).
- Use of EUDAMED for Devices and Certificates registration becomes mandatory by Q2 2029 as per EU MDR article 123(3)(e) and EU IVDR article 113(3)(a).
Urgent Call to Action for Class D IVDR Manufacturers by Team-NB:
Team-NB emphasizes the critical importance of the upcoming deadline for Class D in-vitro diagnostic devices under the IVDR. Given the extended timelines required for conformity assessment
Key points:
- Manufacturers of Class D devices are strongly recommended to submit their applications no later than the end of 2023.
- The Notified Bodies have jointly committed themselves to make time and resources available and by submitting the technical documentation by manufacturers in time it will help to safeguard the supply chain and ensure continued access to Class D IVDs in the EU.
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Regulatory Newsletter (EU)
We provide weekly updates about regulations and guidelines in the European Medical Device and In-Vitro Diagnositc Industry.
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