The USA simplifies regulations while the EU complicates them

One of the most significant take-aways from this year’s MedTech Forum in Brussels is that, while we in the EU have made the regulatory framework for medical devices more complicated, our principal competitor, the USA, has simplified regulations.

FDA co-operative

The changes in the USA have taken place at the request of patient associations, corporate organisations and politicians, while in the EU, it is politicians who have pushed for the changes – which go in the opposite direction to those in the USA. Today, the US Food and Drug Administration (FDA) is co-operative and keen for a constructive dialogue with the industry about what data is and similar issues.

These regulatory changes, which in the long term could give the USA major competitive advantages, we learned about during the CEO session that began the second day of the conference. The session involved Jean-Luc Belingard from French FEFIS, Bernd Montag from Siemens Helthineers and Nadim Yared from CVRx. One of the three CEOs on the panel said (freely translated) “What you call lobbying I call training. You have to get the (often clueless) decision makers to give up their fear of the unknown.” The same person told us that he spends a lot of time knocking on the doors of Capitol Hill.

It may take years to effect changes, but it is necessary to have decision-makers around the table together with patients and business partners when discussing future policies, in order for laws not to block development.

(To the original Swedish language text.)