EU-MDR Lurches Towards US-FDA Approach

The EU MDR (Medical Device Regulation) tends to follow the approach of the US FDA (Food and Drug Administration). In the current situation, it tightens the existing regulatory framework for medical devices in Europe. And it does so in a way that is unacceptable to many market participants.

What Is The Current Trend In The US?

According to a Boston Consulting Group poll, the United States have surpassed the European Union as the most important market for medical device makers. 89 Percent of MedTechs planning to prioritize US Food and Drug Administration (FDA) approval in the future. In one of our earlier posts, we summarized the results of this survey. 

EU-MDR Lurches Towards US-FDA Approach.
EU-MDR Lurches Towards US-FDA Approach, Market Contenders Disagree | Graphics: Ellina Goncharova from Alura Group

Are the MDR’s New EU Standards a Considerable Constraint?

UK-based Healthcare Business International (HBI) thinks the economic impact could be very painful. The author of their blog, David Farbrother, states:

“There is a new threat to healthcare businesses across Europe which, HBI hears, has the potential to have a greater impact than Covid or Brexit in terms of costs.”

He continues: “The EU Medical Device Regulation is now in place after a transition period, and it strengthens the existing regulatory system for medical devices in Europe in a way that many companies find distasteful. The new standards could lead to the EU adopting a US-style FDA approach. Then more clinical data will be required before devices can be approved. It can easily be argued that this will impose additional costs.”

Is Additional Paperwork Necessary for Improved Product Safety?

This question is at the root of many fierce debates. On the one hand, there is the group that believes that additional paperwork only increases costs. But it will not increase the safety of the devices. On the other hand, others point to the PiP affair of 2010. Back then, regulatory and quality control procedures failed. Thousands of women suffered from the health risks of PIP breast implants. Either way, when the EU-MDR lurches towards the US-FDA approach, it is likely that costs will rise.

How Is Britain Taking It?

When it comes to medical devices, the UK now has its own regulation. However, it is more or less the same as the EU’s regulatory system. Critics say the options are two-way: either control can be tightened, or control can be loosened. However, the second option is not attractive to international manufacturers. They argue that producing products at two levels is more difficult than producing one standard product at a higher level.

What Is The Preliminary Conclusion?

After the transition phase, the European Union’s MDR is already in place. It tightens the existing regulatory framework for medical devices in Europe. And that in a way that is unacceptable to many market participants. They find the additional paperwork unnecessary and cost-prohibitive. With the new rules, the EU-MDR lurches towards a US-FDA approach and manufacturers, don’t like that.


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