The Medical Devices Introductory Course 2020

How to Confirm that you have a Medical Device?

 Define the product’s intended purpose  Identify all relevant modes of action and their relative importance in achieving the intended purpose (as substantiated by scientific evidence)  Assess status based on legislation, guidance and borderline manuals (medical device, in-vitro diagnostics, medicinal products, advanced therapy medicinal products, cosmetics, biocides, personal protective equipment, machinery)  Justify and document rationale for your position  For a device, achieve consensus with Notified Body and/or relevant National Competent Authorities  If in doubt, Notified Body (NB) will consult National Competent Authority (NCA)  If in doubt, NCA may consult with other NCA’s (Helsinki Protocol)

Introduction to Medical Devices Regulation in Europe

The Organisation for Professionals in Regulatory Affairs

How to Confirm that you have a Medical Device?

 Define the product’s intended purpose  Identify all relevant modes of action and their relative importance in achieving the intended purpose (as substantiated by scientific evidence)  Assess status based on legislation, guidance and borderline manuals (medical device, in-vitro diagnostics, medicinal products, advanced therapy medicinal products, cosmetics, biocides, personal protective equipment, machinery)  Justify and document rationale for your position  For a device, achieve consensus with Notified Body and/or relevant National Competent Authorities  If in doubt, Notified Body (NB) will consult National Competent Authority (NCA)  If in doubt, NCA may consult with other NCA’s (Helsinki Protocol) MDR: Regulation v. Directive MDCG replace need for consultation between NCAs

Introduction to Medical Devices Regulation in Europe

The Organisation for Professionals in Regulatory Affairs