MedTech
Europe Documents

MedTech Europe Documents

Type
Name
Version
Release Date
Archive
Published EUDAMED documentation launch.
2 Nov, 2022
Industry suggestions for the implementation of EUDAMED.
23 Jun, 2022
Implementation Timeline For EUDAMED
2 Nov, 2022
Important information for EUDAMED users already having access to EUDAMED.
4 Nov, 2022
MDR requirements to ‘legacy devices’ and to devices placed on the market.
2 Nov, 2022
Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers.
2 Nov, 2022
Questions and Answers on repackaging & relabeling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746
2 Nov, 2022
Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers.
2 Nov, 2022
Medical Device Coordination Group Document
2 Nov, 2022

Featured Webinar

Key Insights from Early EUDAMED Testing & Post Go-Live Feedback Webinar

The ever-changing EUDAMED compliance landscape has been flushed with uncertainty. And, although the deadline delays may have come as a welcomed relief to some organizations, the mandate to comply is inevitable!

As one of the few vendors granted early access to the EUDAMED playground, Innovit has been afforded the opportunity to attend meetings, provide commentary, participate in M2M testing and offer our technical insights and IT recommendations. Watch the recording to help navigate your EUDAMED journey ahead!