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MDR Impact on pharma companiesBjorg Hunter
Regulatory Manager, Devices
DDF 2019
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This slide deck represents the views and opinion of the author and is not necessarily a reflection of official policy or position of GSK.
Disclaimer
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Background
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EU MDR and IVDR timelines
https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/640404/MDR_IVDR_guidance_Print_13.pdf
2017 2018 2019 2020 2021 2022
EU MDR &
EU IVDR
Published
EU MDR
implemented
EU IVDR
implemented
Now
EU MDR – 3 Year transitioning period
EU IVDR – 5 Year transitioning period
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Key changes for pharmaceutical manufactures
http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745&from=EN
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Problem statement for Single Integral medicinal products
MDD MDR
Directive 93/42/EEC Art 1.3 Regulation 2017/245 Art 117
Demonstrate compliance with
Annex 1 (all device classes)
Notified Body (NB) opinion (class
IIa devices and above)
Manufacturers working directly
with a Competent Authority (CA)
Manufactures must work with
both the NB and CA
??? Many questions arise ???
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➢ What will be the full scope of the NB review – Annex 1 only or part of the QMS as
well?
➢ Which documents regarding the medical device component will need to be included
in the MAA?
➢ Will there be flexibility for the final NB opinion to be provided in parallel with MAA (for
example by day 120 for MAA reviewed though centralised procedure)?
➢ Will platform approaches or “Master files” be possible for well established platform
products?
➢ Will there be enough appropriately designated NB’s to accommodate the added
workload?
Just some of the questions
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EBE positioning paper
https://www.ebe-biopharma.eu/publication/ebe-efpia-reflection-paper-an-industry-perspective-on-article-117-of-the-eu-medical-devices-regulation-and-the-impact-on-how-medicines-are-assessed/
8
https://www.ebe-biopharma.eu/wp-content/uploads/2018/07/EBE-EFPIA_-Reflection-paper_-Industry-Perspective-on-Art-117-of-MDR_Final_2018.07.12.pdf
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EBE letter to CAMD and HMA
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Agency engagement and guidance
10
➢ Several meetings between EMA, HMA, EU Commission*, CA’s, NB’s and industry
has followed
➢ A Live Q&A document by EMA published in Q1 with more to follow
➢ BWP / QWP working on a guideline on quality requirements for drug device
combinations. Due to be published for public consultation in Q2 2019. The guideline
has been developed in collaboration with Team NB.
*DG-SANTE and DG-GROW
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Classification
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Class Certificate
Medical
device
Certificate
Single
Integral
Class III Notified Body
CExxxx
Notified body
opinionClass IIb
Class IIa
Class I* Self assessment
CE
Self assessment
High
Risk
Low
Risk
* Class I sterile and measurement will also need a Notified body review
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Rule 20 – up classification
12
Examples
MDD MDR
Class I Class IIa or b
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Actions for pharma companies to consider
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✓ Review your portfolio – identify combinations and devices
✓ Review device class
✓ Perform gap analysis
✓ Engage your NB or Identify a NB
✓ Engage across your organisation to ensure alignment across functions
✓ Review quality systems, legal manufacture / authorised representative status
✓ Be mindful of Brexit!
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Case study- MDR compliance for currently approved medical device vs single integral medicinal product
VS
Medical Device Single Integral
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Scope
VS
Medical Device Single Integral
MDR Art 117 (Annex 1)
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Classification
VS
Medical Device Single Integral
MDR
Up-classified I - IIa
Art 117 (Annex 1)
Up-classified I - IIa
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Certificate
VS
Medical Device Single Integral
MDR
Up-classified I - IIa
NB CExxxx
Art 117 (Annex 1)
Up-classified I - IIa
NB opinion
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Timeline
VS
Medical Device Single Integral
MDR
Up-classified I - IIa
NB CExxxx
By 2020 ?
Art 117 (Annex 1)
Up-classified I - IIa
NB opinion
Next major change ?
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Quality system
VS
Medical Device Single Integral
MDR
Up-classified I - IIa
NB CExxxx
By 2020 ?
ISO13485
Art 117 (Annex 1)
Up-classified I - IIa
NB opinion
Next major change ?
GMP
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Conclusion
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Now is the time to take action
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➢ Be aware of the type of device you have, it’s classification and which
regulation it falls under
➢ Engage your business as early as possible to be ready
➢ Engage your Notified Body as early as possible to be ready
➢ Continue to advocate and interreact across the industry and regulators
To meet our collective goal of ensuring timely access
to safe medicines for our patients
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Thank you