Spring Intro 2023

22/03/2023

New EU Medical devices Regulation (MDR) & In-vitro diagnostics Regulation (IVDR) MDR (No 745/2017)replaces the Medical Devices Directive (MDD 93/42/EEC) and the Active Implantable Medical Devices Directive (AIMDD 90/385/EEC), applies from 31 MAY 2021 IVDR (No 746/2017) replaces the repealing Directive 98/79/EC, applicable on 26 May 2022 Extension of transitional period

New classification system

Stronger Regulatory Oversight

Increased Transparency and Traceability

New requirements considered to ensure adequate oversight of devices & manufacturers

The Organisation for Professionals in Regulatory Affairs

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Regulator work-sharing initiatives – ACCESS, ORBIS

Regulators strengthening international collaboration to align on requirements and gain regulatory efficiencies

Potential to lessen regulatory burden and securing simultaneous approvals in multiple countries

ORBIS Participating regulatory authorities: FDA, TGA, Health Canada, Health Sciences Authority of Singapore, Swissmedic, ANVISA and MHRA Framework for concurrent submission and review of oncology products FDA and participating countries consider including additional countries and more varied product applications (e.g., with companion diagnostics)

ACCESS consortium Coalition of regulatory authorities: TGA, Health Canada, Health Sciences Authority of Singapore, Swissmedic, MHRA (ANVISA considering joining)

Aims: promote greater regulatory collaboration and alignment of regulatory requirements

The Organisation for Professionals in Regulatory Affairs

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