The Trilogue discussions between the European Commission, Council and Parliament are to conclude shortly, with likely adoption of a final text in the early Autumn. This mammoth task is the culmination of work initially started in September 2012 but is only the beginning of the legislative changes for medical devices. This year’s ABHI Regulatory Conference will provide delegates with an up-to-the-minute appraisal of the text, it’s timings and an assessment of how to manage the transition period between old and new.
To help you navigate the journey to compliance, the following key topics will be covered during the conference:
- Conformity Assessment – What the changes will mean to you
- Clinical Evidence and Clinical Investigations – What will be expected
- Hazardous Substances – How to keep your devices compliant
- Notified Body Engagement – Getting the best from your NB
- Post Market Surveillance – Extracting the benefits