mdr impact on pharma companiesproblem statement for single integral medicinal products mdd mdr...

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

11

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

12

Examples

MDD MDR

Class I Class IIa or b

Actions for pharma companies to consider

13

✓ 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

21

➢ 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