June 20, 2017 | Hotel Okura, Amsterdam

On June 20, 2017, 11:25 – 12:00: Itoro Udofia, UL, UK will speak on “Clinical Evaluations and Investigations for Medical Devices” at Hotel Okura, Amsterdam.

Notified Body perspective: MEDDEV 2.7.1 Revision 4 key changes and clarifications for clinical evaluations

  • Exploring an overview of the MEDDEV guidance document 2.7.1 Revision 4 and key implications for industry
  • Outlining the key changes impacting Notified Bodies in the new guidance
  • Best practice for performing gap assessments and reviewing the need for additional resources
  • Discussing whether compliance with the new MEDDEV guidance means compliance with the MDR
  • Reviewing what might still not be fulfilled in the MDR, when complying to the new MEDDEV guidance