Global Medical Device Podcast powered by Greenlight Guru Assessing the Global Regulatory Landscape
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:
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)
FDA - Software as a Medical Device (SaMD)
The Greenlight Guru True Quality Virtual Summit
MedTech True Quality Stories Podcast