# 051 - "EU MDR" with Bassil Akra

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2022-09-21
- Length: 44m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2022-09-21-051-eu-mdr-with-bassil-akra
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/051---EU-MDR-with-Bassil-Akra-e1o398b

## Summary

Bassil Akra, CEO of AKRA Team and former VP at TÜV SÜD, explains the implementation challenges of the EU Medical Device Regulation (MDR) 2017/745, focusing on the critical shortage of designated Notified Bodies and the resulting capacity constraints for manufacturers. He details the regulatory distinctions between Notified Bodies and Competent Authorities, clarifying that while Notified Bodies perform conformity assessments, Competent Authorities handle market surveillance and designate the bodies themselves. Akra specifically addresses Article 117 for drug-device combination products, explaining how manufacturers must obtain a Notified Body opinion on the device component if it lacks a CE mark, rather than a full certification, to support the medicinal product's market authorization.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2022-09-21-051-eu-mdr-with-bassil-akra#t=0) Introduction: Bassil Akra and AKRA Team
- [3:26](https://hardwarepodcasts.com/podcast/lets-combinate/2022-09-21-051-eu-mdr-with-bassil-akra#t=206) Akra's Career Transition from Engineering to Regulatory Strategy
- [14:17](https://hardwarepodcasts.com/podcast/lets-combinate/2022-09-21-051-eu-mdr-with-bassil-akra#t=857) EU MDR Implementation Timeline and Notified Body Shortages
- [23:11](https://hardwarepodcasts.com/podcast/lets-combinate/2022-09-21-051-eu-mdr-with-bassil-akra#t=1391) Distinguishing Notified Bodies from Competent Authorities
- [29:22](https://hardwarepodcasts.com/podcast/lets-combinate/2022-09-21-051-eu-mdr-with-bassil-akra#t=1762) Joint Assessments and Authority-Monitored Audits
- [34:07](https://hardwarepodcasts.com/podcast/lets-combinate/2022-09-21-051-eu-mdr-with-bassil-akra#t=2047) Article 117 Requirements for Drug-Device Combination Products
- [39:47](https://hardwarepodcasts.com/podcast/lets-combinate/2022-09-21-051-eu-mdr-with-bassil-akra#t=2387) MDR Changes to Economic Operator Responsibilities

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Scaling production](https://hardwarepodcasts.com/topic/scaling-production)

## Most relevant to

established companies

## Mentioned

- AKRA Team (company)
- TÜV SÜD (company)
- EU MDR (other)
- IVDR (other)
- Article 117 (other)
- EMA (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)
- [[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)
- [Why is IVDR Causing Widespread Panic throughout the Medical Device Industry?](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-05-07-why-is-ivdr-causing-widespread-panic-throughout-the-medical-device-industry) (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/2022-09-21-051-eu-mdr-with-bassil-akra. 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.