The Medical Devices Introductory Course 2020

Into The Future ...

Increasing regulatory control of devices ... • EU MDR and IVDR –

Broader scope: inclusion of certain aesthetic products – New risk classification for IVDs and significant increased NB oversight – Clinical evaluation: adoption of guidelines as regulation – UDI implementation – Stricter obligations for economic operators – Increased oversight of NB – Expanded scrutiny for certain high risk devices

• Regulatory challenges with new technologies ... – Combination products: drug / device converging technologies – Digital / software technologies (AI) – 3D printing / personalisation – Companion diagnostics (CDx)

• International harmonisation and regulatory convergence ... reality or pipe dream?

• Political uncertainty and the compliance pendulum

• Brexit, President Trump, ... AND ...

Into The Future ...

The Organisation for Professionals in Regulatory Affairs