# 099 - Medical Device vs. Medicinal Product Reviews in the EU, Working at MHRA, Notified Bodies, EU MDR, ICH Q6 and Writing All About It with Janine Jamieson

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2023-08-23
- Length: 40m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2023-08-23-099-medical-device-vs-medicinal-product-reviews-in-the-eu-working-at-mhra-notifi
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/099---Medical-Device-vs--Medicinal-Product-Reviews-in-the-EU--Working-at-MHRA--Notified-Bodies--EU-MDR--ICH-Q6-and-Writing-All-About-It-with-Janine-Jamieson-e28cdch

## Summary

Janine Jamieson, European Editor at International Pharmaceutical Quality, explains the regulatory complexities of drug-device combination products in the EU, detailing her tenure as a pharmaceutical assessor at the UK MHRA. She describes the historical challenges of reviewing device-led products without clear pathways, which led to the introduction of Article 117 in the EU MDR to balance device and medicinal product reviews. The conversation covers the current state of notified bodies, the upcoming New Falsified Medicines Directive (New FMD), and the revision of ICH Q6 specifications to decouple safety from manufacturing capability.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2023-08-23-099-medical-device-vs-medicinal-product-reviews-in-the-eu-working-at-mhra-notifi#t=0) Introduction: Janine Jamieson and International Pharmaceutical Quality
- [1:58](https://hardwarepodcasts.com/podcast/lets-combinate/2023-08-23-099-medical-device-vs-medicinal-product-reviews-in-the-eu-working-at-mhra-notifi#t=118) Janine's Start at MHRA and Device-Led Combination Products
- [7:47](https://hardwarepodcasts.com/podcast/lets-combinate/2023-08-23-099-medical-device-vs-medicinal-product-reviews-in-the-eu-working-at-mhra-notifi#t=467) The Regulatory Gap and Introduction of Article 117
- [15:26](https://hardwarepodcasts.com/podcast/lets-combinate/2023-08-23-099-medical-device-vs-medicinal-product-reviews-in-the-eu-working-at-mhra-notifi#t=926) EU Regulatory Structure: MHRA, EMA, and Notified Bodies
- [22:18](https://hardwarepodcasts.com/podcast/lets-combinate/2023-08-23-099-medical-device-vs-medicinal-product-reviews-in-the-eu-working-at-mhra-notifi#t=1338) The New Falsified Medicines Directive and Innovation
- [30:18](https://hardwarepodcasts.com/podcast/lets-combinate/2023-08-23-099-medical-device-vs-medicinal-product-reviews-in-the-eu-working-at-mhra-notifi#t=1818) ICH Q6 Revision and Decoupling Specifications from Manufacturing

## Topics

- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Policy, trade & tariffs](https://hardwarepodcasts.com/topic/policy-trade-and-tariffs)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)

## Most relevant to

established companies

## Mentioned

- MHRA (company)
- EMA (company)
- BSI (company)
- LRQA (company)
- EU MDR (other)
- ICH Q6 (other)
- International Pharmaceutical Quality (company)
- TOPRA (company)

## Related episodes from other shows

- [Assessing the Global Regulatory Landscape](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-10-21-assessing-the-global-regulatory-landscape) (Global Medical Device Podcast)
- [Preparing for EU MDR](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-26-preparing-for-eu-mdr) (Global Medical Device Podcast)
- [#380: Navigating the Complex World of Combination Products with Subhi Saadeh](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-08-30-380-navigating-the-complex-world-of-combination-products-with-subhi-saadeh) (Global Medical Device Podcast)
- [#339: UDI and the State of EUDAMED](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-10-12-339-udi-and-the-state-of-eudamed) (Global Medical Device Podcast)
- [[LIVE] How EU MDR Changes are Impacting the Medical Device Ecosystem](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-04-22-live-how-eu-mdr-changes-are-impacting-the-medical-device-ecosystem) (Global Medical Device Podcast)

## Citing this page

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