Episode 232  |  24:11 min  |  10.20.2021

Assessing the Global Regulatory Landscape

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This is a podcast episode titled, Assessing the Global Regulatory Landscape. The summary for this episode is: <p>With medical device regulations tightening around the world, especially in Europe, it's important to assess the changes unfolding across the global regulatory landscape in order to fully understand how it impacts your business and product.</p><p>In this episode of the Global Medical Device Podcast Jon Speer talks to Adnan Ashfaq, founder of Simplimedica, about the changing global regulatory landscape, offering many valuable nuggets of wisdom to help medical device professionals navigate those changes accordingly.</p><h3><strong>Some of the highlights of this episode include:</strong></h3><ul><li>Adnan describes the transition to EU MDR as an interesting but rocky and rolling landscape. Some companies acted quickly, but others are still waiting to take action and are not convinced of things that they have to do.</li><li>Pieces are still being put in place. Medical device and in vitro diagnostic regulations have their own massive challenges. Also, there’s challenges with EUDAMED, designated notified bodies, and SaMD.</li><li>EU MDR was supposed to go into effect in May 2020, but due to COVID-19 and other reasons, it was pushed off for a year. Guidance drafts were available in 2014-2015, but only a few hundred companies have made that full transition.</li><li>According to a survey conducted by RWS, 53% of organizations are impacted by both EU MDR and IVDR, yet only 4% of those organizations admit that the regulations are a top priority.</li><li>Companies with a medical device should proceed to effectively implement EU MDR or it may cost them their business. Also, refer to the definition of medical device that includes monitoring, prediction, and prognosis.</li><li>Adnan encourages companies to not underestimate the cost of quality and regulatory. Build it in and know your market. With labeling and packaging, don’t forget about Brexit and associated symbols/marks.</li><li>Regulations happened to catch up with technological advancements and public safety to become more transparent because patients were traumatized or died due to failure of efficacy in medical devices not being tested appropriately.</li></ul><h3><strong>Memorable quotes from Adnan Ashfaq:</strong></h3><p><em>“They’ve really had to rethink their entire commercial strategy - whether they want to keep their devices within the European market, whether it’s financially feasible for them to continue doing that, or whether they want to rethink their entire strategy and think globally where their best markets are.”</em></p><p><em>“I think it really boils down to what is the priority, and a lot of businesses don’t actually realize to keep themselves in business that they need to see this as a high priority.”</em></p><p><em>“Regulations are mandatory, they are not optional.”</em></p><p><em>“Don’t underestimate the cost of quality and regulatory and very often, that is done. You have to build it in. You have to know your market.”</em></p><h3><strong>Links:</strong></h3><p><a href="https://uk.linkedin.com/in/adnan-ashfaq-44478121" rel="noopener noreferrer" target="_blank">Adnan Ashfaq on LinkedIn</a></p><p><a href="https://simplimedica.com/" rel="noopener noreferrer" target="_blank">Welcome to Simplimedica - Simplifying Device Regulation</a></p><p><a href="https://ec.europa.eu/health/md_sector/new_regulations/guidance_en" rel="noopener noreferrer" target="_blank">Guidance - MDCG endorsed documents and other guidance - Public Health - European Commission</a></p><p><a href="https://eumdr.com/" rel="noopener noreferrer" target="_blank">European Union Medical Device Regulation (EU MDR)</a></p><p><a href="https://euivdr.com/" rel="noopener noreferrer" target="_blank">European Union In Vitro Diagnostic Regulation (EU IVDR)</a></p><p><a href="https://www.rws.com/about/news/2021/rws-mdr-ivdr-research/" rel="noopener noreferrer" target="_blank">RWS - Almost three-quarters of medical device companies ready to meet the European Union’s MDR and IVDR regulations</a></p><p><a href="https://ec.europa.eu/tools/eudamed/" rel="noopener noreferrer" target="_blank">EUDAMED</a></p><p><a href="https://www.fda.gov/medical-devices/digital-health-center-excellence/software-medical-device-samd" rel="noopener noreferrer" target="_blank">FDA - Software as a Medical Device (SaMD)</a></p><p><a href="https://www.bbc.com/news/uk-politics-32810887" rel="noopener noreferrer" target="_blank">Brexit</a></p><p><a href="https://www.greenlight.guru/academy" rel="noopener noreferrer" target="_blank">Greenlight Guru Academy</a></p><p><a href="https://virtual-summit.greenlight.guru/" rel="noopener noreferrer" target="_blank">The Greenlight Guru True Quality Virtual Summit</a></p><p><a href="https://www.greenlight.guru/podcast-mtqs" rel="noopener noreferrer" target="_blank">MedTech True Quality Stories Podcast</a></p><p><a href="https://www.youtube.com/channel/UCYfQsPqHW8H8mZ4xpM4gn1Q" rel="noopener noreferrer" target="_blank">Greenlight Guru YouTube Channel</a></p><p><a href="https://www.greenlight.guru/" rel="noopener noreferrer" target="_blank">Greenlight Guru</a></p>

With medical device regulations tightening around the world, especially in Europe, it's important to assess the changes unfolding across the global regulatory landscape in order to fully understand how it impacts your business and product.

In this episode of the Global Medical Device Podcast Jon Speer talks to Adnan Ashfaq, founder of Simplimedica, about the changing global regulatory landscape, offering many valuable nuggets of wisdom to help medical device professionals navigate those changes accordingly.

Some of the highlights of this episode include:

  • Adnan describes the transition to EU MDR as an interesting but rocky and rolling landscape. Some companies acted quickly, but others are still waiting to take action and are not convinced of things that they have to do.
  • Pieces are still being put in place. Medical device and in vitro diagnostic regulations have their own massive challenges. Also, there’s challenges with EUDAMED, designated notified bodies, and SaMD.
  • EU MDR was supposed to go into effect in May 2020, but due to COVID-19 and other reasons, it was pushed off for a year. Guidance drafts were available in 2014-2015, but only a few hundred companies have made that full transition.
  • According to a survey conducted by RWS, 53% of organizations are impacted by both EU MDR and IVDR, yet only 4% of those organizations admit that the regulations are a top priority.
  • Companies with a medical device should proceed to effectively implement EU MDR or it may cost them their business. Also, refer to the definition of medical device that includes monitoring, prediction, and prognosis.
  • Adnan encourages companies to not underestimate the cost of quality and regulatory. Build it in and know your market. With labeling and packaging, don’t forget about Brexit and associated symbols/marks.
  • Regulations happened to catch up with technological advancements and public safety to become more transparent because patients were traumatized or died due to failure of efficacy in medical devices not being tested appropriately.

Memorable quotes from Adnan Ashfaq:

“They’ve really had to rethink their entire commercial strategy - whether they want to keep their devices within the European market, whether it’s financially feasible for them to continue doing that, or whether they want to rethink their entire strategy and think globally where their best markets are.”

“I think it really boils down to what is the priority, and a lot of businesses don’t actually realize to keep themselves in business that they need to see this as a high priority.”

“Regulations are mandatory, they are not optional.”

“Don’t underestimate the cost of quality and regulatory and very often, that is done. You have to build it in. You have to know your market.”

Links:

Adnan Ashfaq on LinkedIn

Welcome to Simplimedica - Simplifying Device Regulation

Guidance - MDCG endorsed documents and other guidance - Public Health - European Commission

European Union Medical Device Regulation (EU MDR)

European Union In Vitro Diagnostic Regulation (EU IVDR)

RWS - Almost three-quarters of medical device companies ready to meet the European Union’s MDR and IVDR regulations

EUDAMED

FDA - Software as a Medical Device (SaMD)

Brexit

Greenlight Guru Academy

The Greenlight Guru True Quality Virtual Summit

MedTech True Quality Stories Podcast

Greenlight Guru YouTube Channel

Greenlight Guru

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