Module 18 - Drug Device Combinations and Other Technologies

04/12/2023

Public

Article 117 – Key change in ways of working

Process before MDR •

MAA Including ERs

MAA submitted directly to Competent Authority

•

MDD Annex 1 Essential Requirements (ERs) self certified checklist

PHARMA COMPANY

MDR Requirements

MAA +

NBOp

GSPRs

NBOp

• MAA to be submitted with a Notified Body opinion (NBOp) • MDR Annex 1 General Safety and Performance Requirements (GSPRs)

PHARMA COMPANY

PHARMA COMPANY

NOTIFIED BODY

Could be ~ 6 month review period

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Article 117 – Impact on Pharmaceutical Companies

• Need to find & work with a MDR designated Notified Body • This is a big concern – A new stakeholder, availabilities and timelines

• Need to obtain Notified Body assessment report • Include this assessment report in the MAA • Applied to all new MAAs after 26th May 2021 –At this time a limited no of MBs designated to MDR • In case of changes to device, Notified Body reassessment required for substantial change to the device

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