Articles by Marcelo Trevino

1. AI In Medical Devices: Meeting The Regulatory Challenge Around The World, Part 2 5/13/2025

   This article focuses on the common regulatory threads that connect different regions and the global standards and principles being developed to bring consistency, safety, and trust to AI innovation in medical devices.

2. AI In Medical Devices: Meeting The Regulatory Challenge Around The World, Part 1 5/1/2025

   This article explores the global regulatory landscape, examining how leading authorities in the U.S., EU, U.K., Canada, China, Brazil, Australia, and South Korea are approaching AI in medical devices. 

3. Navigating The 2025 Medtech Regulatory Landscape In Switzerland And The U.K. 3/26/2025

   Switzerland is working toward reestablishing its relationship with the EU while exploring new avenues. Meanwhile, the U.K. is still rebuilding its regulatory framework post-Brexit.

4. Mastering EU MDR & IVDR: Certification Compliance For Medical Device Importers And Distributors 2/24/2025

   Article 16 of the European Union’s Medical Device Regulation and In Vitro Diagnostic Regulation specifically address the obligations of importers and distributors who engage in relabeling and repackaging activities.

    

5. 9 Strategies To Overcome Challenges In The EU Medical Device Market In 2025 And Beyond 12/17/2024

   Current challenges in Europe's medical device market include the EU MDR transition and a lack of harmonization. Device manufacturers, regulators, and other stakeholders can take these key actions to create positive change.

6. Understanding The New MHRA Requirements For Medical Devices In Great Britain 4/9/2024

   The U.K.’s MHRA has updated its transition arrangement dates for CE marked devices with regard to EU MDR compliance.

7. The FDA & EU IVDR Regulatory Frameworks For IVD SaMD 1/4/2023

   Software that is qualified as an in vitro diagnostic medical device (known as SaMD IVD) is affected by the same requirements as other medical devices, which are governed by various FDA regulations and EU In Vitro Diagnostic (IVD) Regulation EU 2017/746.

8. Does The FDA Or EU IVDR Consider IVD Software An IVD Medical Device? 12/16/2022

   Software with a medical intended use can be embedded as part of a medical device, or it can also be considered a medical device by itself and regulated as Software as a Medical Device (SaMD). In vitro diagnostic devices are known as IVD SaMD. This article summarizes the regulatory requirements in the EU, governed by the In Vitro Diagnostics Regulation (IVDR), and the requirements in the U.S., governed by the FDA.

9. Implementing EU MDR and IVDR: Lessons Learned, Part 2 3/31/2021

   The first article in this two-part series covered details associated with economic operator responsibilities, overall QMS considerations, and common challenges during implementation of the EU’s Medical Device Regulation (MDR) and the EU’s In Vitro Device Regulation (IVDR). This article focuses on typical challenges experienced during the technical documentation assessments conducted by the notified bodies.

10. Implementing EU MDR and IVDR: Lessons Learned, Part 1 3/24/2021

    The transition to the EU’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) is not an easy undertaking. This first article in a two-part series highlights the sections that need close attention regarding economic operator responsibilities, overall QMS considerations, and common challenges during implementation. Ensure a smooth transition and avoid pitfalls!