MDR Impact on pharma companiesBjorg Hunter
Regulatory Manager, Devices
DDF 2019
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
Background
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
Key changes for pharmaceutical manufactures
http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745&from=EN
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 ???
➢ 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
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
EBE letter to CAMD and HMA
9
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
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
Rule 20 – up classification
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Examples
MDD MDR
Class I Class IIa or b
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!
Case study- MDR compliance for currently approved medical device vs single integral medicinal product
VS
Medical Device Single Integral
Scope
VS
Medical Device Single Integral
MDR Art 117 (Annex 1)
Classification
VS
Medical Device Single Integral
MDR
Up-classified I - IIa
Art 117 (Annex 1)
Up-classified I - IIa
Certificate
VS
Medical Device Single Integral
MDR
Up-classified I - IIa
NB CExxxx
Art 117 (Annex 1)
Up-classified I - IIa
NB opinion
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 ?
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
Conclusion
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
Thank you