# 074 - Article 117, EU MDR extension, Notified Body Opinions, Timing and Interaction with Christiana Hoffman

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2023-03-01
- Length: 28m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2023-03-01-074-article-117-eu-mdr-extension-notified-body-opinions-timing-and-interaction-w
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/074---Article-117--EU-MDR-extension--Notified-Body-Opinions--Timing-and-Interaction-with-Christiana-Hoffman-e1vgtv4

## Summary

Christiana Hoffman, Executive Consultant at anteris medical GmbH and former TÜV SÜD expert, explains the regulatory framework for drug-device combination products under EU MDR Article 117. She details the requirement for Notified Body Opinions for products like prefilled syringes, the distinction between GMP and ISO 13485, and the strict prohibition on consulting during the assessment process. Hoffman also outlines the timeline challenges, noting that assessments can take 75 days plus response time, and advises manufacturers to start the process 6-12 months before their EMA submission.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2023-03-01-074-article-117-eu-mdr-extension-notified-body-opinions-timing-and-interaction-w#t=0) Introduction and Christiana Hoffman's Background
- [3:30](https://hardwarepodcasts.com/podcast/lets-combinate/2023-03-01-074-article-117-eu-mdr-extension-notified-body-opinions-timing-and-interaction-w#t=210) EU MDR Differences and Article 117 Scope
- [6:44](https://hardwarepodcasts.com/podcast/lets-combinate/2023-03-01-074-article-117-eu-mdr-extension-notified-body-opinions-timing-and-interaction-w#t=404) Quality Systems: GMP vs ISO 13485
- [8:29](https://hardwarepodcasts.com/podcast/lets-combinate/2023-03-01-074-article-117-eu-mdr-extension-notified-body-opinions-timing-and-interaction-w#t=509) Rationale and Requirements of Article 117
- [13:35](https://hardwarepodcasts.com/podcast/lets-combinate/2023-03-01-074-article-117-eu-mdr-extension-notified-body-opinions-timing-and-interaction-w#t=815) Documentation Challenges and Shelf Life Data
- [16:24](https://hardwarepodcasts.com/podcast/lets-combinate/2023-03-01-074-article-117-eu-mdr-extension-notified-body-opinions-timing-and-interaction-w#t=984) The Notified Body Opinion Submission Process
- [19:17](https://hardwarepodcasts.com/podcast/lets-combinate/2023-03-01-074-article-117-eu-mdr-extension-notified-body-opinions-timing-and-interaction-w#t=1157) Consultation Rules and MDR Extension Impact
- [23:35](https://hardwarepodcasts.com/podcast/lets-combinate/2023-03-01-074-article-117-eu-mdr-extension-notified-body-opinions-timing-and-interaction-w#t=1415) Timelines, Eudamed, and Strategic Advice

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)

## Most relevant to

established companies

## Mentioned

- anteris medical GmbH (company)
- TÜV SÜD (company)
- EU MDR (other)
- Eudamed (other)
- EMA (company)
- ISO 13485 (other)
- GMP (other)

## Related episodes from other shows

- [Tips to Prepare for EU MDR and IVDR as Deadlines Draw Near](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-12-17-tips-to-prepare-for-eu-mdr-and-ivdr-as-deadlines-draw-near) (Global Medical Device Podcast)
- [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)
- [[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)
- [How does EU MDR impact your Quality Management System?](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-02-22-how-does-eu-mdr-impact-your-quality-management-system) (Global Medical Device Podcast)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/lets-combinate/2023-03-01-074-article-117-eu-mdr-extension-notified-body-opinions-timing-and-interaction-w. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Let's Combinate.