New Regulations: The way ahead - MediWales€¦ · New Regulations: The way ahead John Wilkinson,...
Transcript of New Regulations: The way ahead - MediWales€¦ · New Regulations: The way ahead John Wilkinson,...
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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