The Medical Devices Introductory Course 2020

Comparison of Regulatory Systems

Medical Device CE mark allows access to all EU & EFTA Countries, without national measures Based on quality, safety, performance and risk/benefit Compliance with ERs / GSPRs underpinned by EU and International standards NBs verify that manufacturers meet requirements Level of scrutiny / Costs vary between NBs and Device Risk Classification Timescale for review varies between NBs Proportional approach

Medicinal Product Single market (for centrally authorized products) and individual MS participate in approval process (i.e. CHMP) Based on quality, safety, efficacy and risk/benefit Compliance with prescriptive data requirements underpinned by guidelines CA assesses and authorises each individual product High regulatory approval costs Same procedure applies to all products Timescale for review prescribed in legislation Precautionary approach

The Organisation for Professionals in Regulatory Affairs

Overlap of Legislation when combining a drug and medical device

Device Legislation

Medicines Legislation

The Organisation for Professionals in Regulatory Affairs