Euro Convergence: Attendees want end to regulatory ‘micromanagement’

Corrected 13 May 2022*

AMSTERDAM – Regulatory professionals have a big ask for regulators and other health authorities: Trust us.
 
Gathered at RAPS Euro Convergence at a panel on how to better communicate with health authorities and notified bodies, they voiced their displeasure and asked for a respite from what they describe as micromanagement.
 
“You heard from academia, you heard from the early start-ups, you heard from the large manufacturers [at this conference],” said Gert Bos, president of RAPS and CSO of medical device consultancy group Qserve. “They're all very polite and nice and friendly but if I talk to them in the corridor, or if they come to my consultancy firm, steam comes out of their ears… they’re frustrated.”
 
Bos argued industry is in a Catch-22, with a lot of regulations that seem to nitpick how products get to market while lacking guidance in areas where it is  needed. He said regulators and other stakeholders need to focus on the issues that matter – such  as figuring out what is good enough to get innovative products to market and what’s needed to make improvements to existing products.
 
“The only way that we can do that is by committing ourselves to stop the micromanagement, because a lot of the system is about fear and micromanagement,” said Bos. “Stop the micromanagement and start trusting each other again. Work together, build that relationship between all the stakeholders and start showing our human face. 
 
“We all have the same purpose: Whether you are industry, regulator or anywhere in between – a notified body or consultant – we all do this because we like the technology, we love the innovation, but above all we want to help the patients,” he added. “So, get over ourselves, trust each other, communicate smoother, and make expectations clear that we want innovation and this is how we're going do it together.”

Bos also argued that the medical device regulatory oversight has traditionally worked well to ensure patients are not subjected to potentially harmful products. He noted that over the past few years there have been news reports, particularly the Implant Files from the International Consortium of Investigative Journalists, that highlight instances where dangerous devices ended up hurting patients.
 
Bos however says that the reports themselves are evidence that the regulatory system works, because cases of patient harm are so few and far in-between. He says the low number of such cases is because regulators trusted device-makers to be ethical and produce safe products.
 
“These stories are like a decade old and so, to me, that says that the system that we have, even the old system and the legacy products, is fairly good because we trusted each other,” said Bos. “But somewhere along the line, we lost the trust in each other.”
 
“I think that we should just say, as of today, we trust each other again, and let's now work together,” he added.
 
Tom Melvin, former medical devices clinical manager for Ireland's Health Products Regulatory Authority, agreed with Bos and spoke about how to develop a better regulatory system for devices. He noted that the current system for regulating devices is based on a drug regulatory mindset and isn’t necessarily fit for purpose. But changing it will require political will.
 
“Firstly, we need better engagement from [the Medical Device Coordination Group (MDCG)] and the political side of the public institutions here to recognize the problem,” said Melvin, who is currently associate professor of medical device regulatory affairs at Trinity College, Dublin.
 
The expert panels need to make a bigger push to develop documents such as those on common specifications and guidances that are more technology-focused as well as more clinical study-specific, Melvin said. He also advised that the most efficient way to set up a better regulatory system is by producing guidances and common specifications that focus on areas with the most uncertainty for product developers.
 
“That will allow the system to hopefully free itself by having more predictable guidances,” Melvin added.
 
Alan Fraser, chair of the Regulatory Affairs Committee of the Biomedical Alliance in Europe and a consultant cardiologist at the University Hospital of Wales, Cardiff, UK, who was in the audience, rhetorically asked the panel whether they had any thoughts about “Why we're in this mess?”
 
“My impression going to [European] Commission meetings is that there are too many lawyers looking at too much small print and they’re not thinking of the basic principles,” Fraser said. “When I read the regulations, I don't see the restrictions that they're implementing in practice, so I think it's too tight for interpretation without finding their way through the system.
 
“If you agree with that, then we should be challenging the lawyers collectively from all the different stakeholders,” Fraser added.
 
Another key topic during the session was on getting feedback from European regulators during the product development stage, similar to the Q-Submission process employed by the US Food and Drug Administration for medical devices. The European Commission and Member States define such feedback as consultancy that goes against its regulations. (Related: Euro Convergence: AI, notified body shortage top health authorities session, 11 March, 2022, Regulatory Focus)
 
Ronald Boumans, a medical regulations consultant with Emergo by UL, recommended the notified bodies should lobby the EMA to define consulting in a way that would allow for early feedback opportunities. He said if they were unified on the issue, it would force the agency to accept such early conversations.
 
“There’s safety in numbers,” he said. “If all notified bodies joined forces (and insisted on doing it), let’s see what happens.”
 
“So basically, what you’re suggesting Ronald is this brave new world, that we step up, that we say to our designating authorities that you’re not overly strict,” said Sabina Hoekstra-van den Bosch, session moderator and regulatory strategy principal at TUV SUD Medical Health Services. “But the signs that we get from the [Medical Device Coordinating Group] is that they are not intending to be a little bit more lenient on this… it really will require a lot of courage.”

*A previous version of this story incorrectly cited the European Medicines Agency (EMA) as the relevant regulator, when the European Commission was the correct authority. Regulatory Focus regrets the error.