Is Global Medical Device Regulation Just a Pipe Dream?

Etienne Nichols, a medical device guru and community manager at Greenlight Guru, recently posed an interesting question to his LinkedIn network: If you were in charge, what regulation would you change, and how would you change it?

Nichols set up the discussion by noting that medtech regulations are complex and ever-changing. He pointed to the recent news that regulatory authorities in the European Union are pushing to extend the deadlines for certification under the new Medical Devices Regulation, and to FDA's proposal to replace the Quality System Regulation with a newly named Quality Management System Regulation.

"I don't know how to do this specifically, but I wish there was more international harmonization," Nichols said in a comment on his post.

To that, John Tidy, director of quality assurance and regulatory affairs at Stirling Compliance, based in Pretoria, South Africa, chimed in: "How about a global medical regulator? I know it's a bit of a pipe dream," Tidy acknowledged. "Pooled international resources and true global harmonization. A single, common entry point for all medical products, for all regions."

It's not a new concept in the world of medical device regulation. Back in 1996, one expert envisioned a globally harmonized system for regulating medical devices, which he predicted at the time would be in place within a decade. That expert was Gordon Higson, who served as the chairman of the International Organization for Standardization's technical committee that worked to apply quality systems standards to the design and manufacture of medical devices – ISO TC 210.

That vision did not come to fruition within a decade, or even two decades. It likely won't happen in the coming decade either. But, perhaps, some day the industry will have a single entity for global medical device regulation.

Another interesting comment on Nichols' post was about the regulation of digital health technologies.

"The one that seems to be begging to be changed, even by the FDA's own admission in their recent whitepaper, is regulatory authority around digital health solutions," commented George Zack, principal and co-founder at Two Harbors Consulting. Then, making a reference to J. R. R. Tolkien's fictional world of Middle-earth, he added, "Of course, if that were easy, we would have already marched into Mordor and made it a Gondor."