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Episode 202  |  38:03 min

Why is IVDR Causing Widespread Panic throughout the Medical Device Industry?

Episode 202  |  38:03 min  |  05.06.2021

Why is IVDR Causing Widespread Panic throughout the Medical Device Industry?

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This is a podcast episode titled, Why is IVDR Causing Widespread Panic throughout the Medical Device Industry?. The summary for this episode is: <p><span style="background-color: transparent; color: rgb(0, 0, 0);">Is the widespread panic over the EU In-vitro Diagnostics Regulation (IVDR) justified? For many device professionals, the one year countdown to the IVDR deadline in May 2022 is almost here, causing much anxiety about whether compliance is even possible.</span></p><p><span style="background-color: transparent; color: rgb(0, 0, 0);">In this episode of the Global Medical Device Podcast, Jon Speer and his guest Joanne LeBrun, VP of Quality Systems at MDC Associates, shine light on EU IVDR transition concerns and the challenges the medical device industry faces, like the notified body shortage.</span></p><h3><strong style="background-color: transparent; color: rgb(67, 67, 67);">Some highlights of this episode include:</strong></h3><ul><li><span style="background-color: transparent;">Why are some notified bodies not interested? There’s a ton of work, audits, and corrective actions. They don’t view it as necessary to move forward and pursue.</span></li><li><span style="background-color: transparent;">First, notified bodies plan a wait-and-see approach to find out how the EU MDR goes on May 27. The notified bodies are overwhelmed and resources are limited.</span></li><li><span style="background-color: transparent;">The EU MDR has more constituents involved and is a bit more straightforward to implement than the IVDR. The IVDR has less constituents but more things that are different, such as product classification.</span></li><li><span style="background-color: transparent;">The opportunity to self-certify for MDR has passed and certain notified bodies are no longer accepting new clients. You can contact your authorized representative about cut-off dates to get your CE mark.</span></li><li><span style="background-color: transparent;">Even if you don’t have to submit a technical documentation file, you still need to have one and review it constantly. Make it part of your change controls,</span></li><li><span style="background-color: transparent;">For ISO/MDSAP certifications and audits, do not have duplicates of files and documentation. Only have one source of information or you are setting yourself up for failure and will be out of compliance.&nbsp;</span></li><li><span style="background-color: transparent;">Notified bodies are not designed to teach regulatory and quality professionals what they should know to be ready. Prepare and reach out before it is too late.</span></li></ul><h3><strong style="background-color: transparent; color: rgb(67, 67, 67);">Memorable quotes from Joanne LeBrun:</strong></h3><p><em style="background-color: transparent; color: rgb(0, 0, 0);">“One of the conditions of going live for the IVDR is that they have seven notified bodies by the time we’re supposed to go live. They have a year to get more notified bodies.”</em></p><p><em style="background-color: transparent; color: rgb(0, 0, 0);">“I think that notified bodies are very overwhelmed.”</em></p><p><em style="background-color: transparent; color: rgb(0, 0, 0);">“While the MDR has more constituents involved, I think that it’s going to be a little more straightforward to implement than the IVDR. The IVDR has less constituents but way more things that are different - particularly product classification.”&nbsp;</em></p><p><em style="background-color: transparent; color: rgb(0, 0, 0);">“That honor system is now gone, and we all have to keep up on it. You really do need to update your technical file all the time.”</em></p><h3><strong style="background-color: transparent; color: rgb(67, 67, 67);">Links:</strong></h3><p><a href="https://www.linkedin.com/in/joanne-lebrun-76b15a10" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">Joanne LeBrun on LinkedIn</a></p><p><a href="https://www.mdcassoc.com/" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">MDC Associates</a></p><p><a href="https://www.fda.gov/medical-devices" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">FDA - Medical Devices</a></p><p><a href="https://ec.europa.eu/growth/content/medical-devices-regulationin-vitro-diagnostics-regulation-mdrivdr-roadmap_en" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">EU IVDR</a></p><p><a href="https://eumdr.com/" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">EU MDR</a></p><p><a href="https://ec.europa.eu/growth/single-market/goods/building-blocks/notified-bodies_en" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">Notified Bodies</a></p><p><a href="https://ec.europa.eu/growth/tools-databases/nando/" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">New Approach Notified and Designated Organizations (NANDO)</a></p><p><a href="https://www.iso.org/standard/59752.html" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">ISO 13485:2016</a></p><p><a href="https://www.iso.org/standard/72704.html" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">ISO 14971:2019</a><span style="background-color: transparent; color: rgb(0, 0, 0);">&nbsp;</span></p><p><a href="https://www.iso.org/standard/74437.html" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">ISO/TR 24971:2020</a></p><p><a href="https://www.fda.gov/medical-devices/cdrh-international-programs/medical-device-single-audit-program-mdsap" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">Medical Device Single Audit Program (MDSAP)</a></p><p><a href="https://www.fda.gov/media/135138/download" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">Overview of the 510(k) Process</a></p><p><a href="https://www.linkedin.com/in/allisonkomiyama" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">Allison Komiyama from AcKnowledge Regulatory Strategies</a></p><p><a href="https://www.greenlight.guru/blog/quality-management-for-ivd-devices-vs-medical-devices" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">Global Medical Device Podcast, EP 193: Quality Management for IVD Devices vs Medical Devices with Joanne LeBrun</a><span style="background-color: transparent; color: rgb(0, 0, 0);">&nbsp;</span></p><p><a href="https://www.greenlight.guru/academy" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">Greenlight Guru Academy</a></p><p><a href="https://www.greenlight.guru/academy" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">Greenlight Guru Academy</a></p><p><a href="https://www.youtube.com/channel/UCYfQsPqHW8H8mZ4xpM4gn1Q" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">Greenlight Guru YouTube Channel</a></p><p><a href="https://www.greenlight.guru/podcast-mtqs" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">MedTech True Quality Stories Podcast</a></p><p><a href="https://www.greenlight.guru/" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">Greenlight Guru</a></p>

Is the widespread panic over the EU In-vitro Diagnostics Regulation (IVDR) justified? For many device professionals, the one year countdown to the IVDR deadline in May 2022 is almost here, causing much anxiety about whether compliance is even possible.

In this episode of the Global Medical Device Podcast, Jon Speer and his guest Joanne LeBrun, VP of Quality Systems at MDC Associates, shine light on EU IVDR transition concerns and the challenges the medical device industry faces, like the notified body shortage.

Some highlights of this episode include:

  • Why are some notified bodies not interested? There’s a ton of work, audits, and corrective actions. They don’t view it as necessary to move forward and pursue.
  • First, notified bodies plan a wait-and-see approach to find out how the EU MDR goes on May 27. The notified bodies are overwhelmed and resources are limited.
  • The EU MDR has more constituents involved and is a bit more straightforward to implement than the IVDR. The IVDR has less constituents but more things that are different, such as product classification.
  • The opportunity to self-certify for MDR has passed and certain notified bodies are no longer accepting new clients. You can contact your authorized representative about cut-off dates to get your CE mark.
  • Even if you don’t have to submit a technical documentation file, you still need to have one and review it constantly. Make it part of your change controls,
  • For ISO/MDSAP certifications and audits, do not have duplicates of files and documentation. Only have one source of information or you are setting yourself up for failure and will be out of compliance. 
  • Notified bodies are not designed to teach regulatory and quality professionals what they should know to be ready. Prepare and reach out before it is too late.

Memorable quotes from Joanne LeBrun:

“One of the conditions of going live for the IVDR is that they have seven notified bodies by the time we’re supposed to go live. They have a year to get more notified bodies.”

“I think that notified bodies are very overwhelmed.”

“While the MDR has more constituents involved, I think that it’s going to be a little more straightforward to implement than the IVDR. The IVDR has less constituents but way more things that are different - particularly product classification.” 

“That honor system is now gone, and we all have to keep up on it. You really do need to update your technical file all the time.”

Links:

Joanne LeBrun on LinkedIn

MDC Associates

FDA - Medical Devices

EU IVDR

EU MDR

Notified Bodies

New Approach Notified and Designated Organizations (NANDO)

ISO 13485:2016

ISO 14971:2019 

ISO/TR 24971:2020

Medical Device Single Audit Program (MDSAP)

Overview of the 510(k) Process

Allison Komiyama from AcKnowledge Regulatory Strategies

Global Medical Device Podcast, EP 193: Quality Management for IVD Devices vs Medical Devices with Joanne LeBrun 

Greenlight Guru Academy

Greenlight Guru Academy

Greenlight Guru YouTube Channel

MedTech True Quality Stories Podcast

Greenlight Guru

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