We hosted an MDR Workshop on Software as a Medical Device on Wednesday 21 April. This workshop involved a panel of speakers looking at the issues from legal, regulatory consultant and notified body perspectives. They provided practical guidance on how to get software medical devices onto the European market under the upcoming MDR and provided a deep dive on new obligations arising under the MDR. They provided practical guidance on how to get software medical devices onto the European market under the upcoming MDR and provided a deep dive on new obligations arising under the MDR.
The Workshop covered the following topics:
- Classification
- Apps
- Verification and Validation Testing Requirements
- Clinical Evidence Requirements
- Conformity Assessment
- Post Market Surveillance Obligations
- Post Market Clinical Follow up
- The panel will use a practical example of a fictional software medical device to talk interested parties through their obligations and what is expected of them in the fast-approaching new European regulatory framework.
Speakers included:
James Gallagher, Senior Associate, Mason Hayes & Curran LLP
Richard Poate, Business Development Manager, TÜV SÜD
Alexandros Charitou, Associate Partner, UK & Ireland Life Science Commercial Edge and MedTech lead, EY
Dr Andrei Ninu, Lead Auditor, TÜV SÜD
To request a recording of the webinar, please contact us at events@mhc.ie
