New Regulations: The way ahead John Wilkinson, Director of Devices

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Brexit

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Implementation

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Transition periods Devices can be placed on the market under

new Regs EUDAMED fully operational?

‘Spring’ 2017

Regulations formally adopted and enter into force

‘Spring’ 2020

MDR fully applied

‘Spring’ 2022

IVDR fully applied

NBs can request re-designation

EUDAMED related requirements begin to

take effect?

2017 2018 2019 2020 2021 2022 2023

MDCG established

Annex XV common

specifications

Reference lab designation

NB re-designations

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EU activity; cluster approach

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Implementation- European Commission

•  Impact assessment •  Common specifications (e.g. Annex XV,

re-processing) •  Mandatory Implementing Acts •  Eudamed

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Implementation – System-wide

•  Notified Body designations •  Pre-market scrutiny- expert panel/ ref lab

composition •  Guidance requirements (e.g. software) •  Economic operator responsibilities/ education •  System coordination of implementation work

streams

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Implementation - MHRA

• Impact assessment

• Public consultation (re-processing, in-house manufacture etc.) - Caveats

• Statutory instrument

• Sanctions

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