Complicated EU approval: Medical products are sometimes in short supply

Clinics in the EU lack the tools or equipment to carry out sometimes vital treatments. The reason is not just supply bottlenecks in times of crisis, but the difficult approval process.

Anyone who thinks of a shortage of supplies in the medical sector in these times of crisis may think of some medicines that could no longer be produced due to gaps in the supply chains or energy shortages. Or the lack of staff in nursing, or still the corona pandemic. But probably less because medical instruments and medical technology could also be missing. But that’s actually the case – at least in some areas where you usually don’t look closely unless you’re affected. And that has nothing to do with the crisis or pandemic, but also with EU regulation that means well, but does not do well.

It’s about things that initially sound bureaucratic and complex, according to European rules. Which seem difficult to understand. In fact, in this case, human lives are at stake.

We are talking about the EU Medical Devices Regulation, the so-called Medical Device Regulation. It is a regulation designed to ensure that only medical devices that have gone through a strict approval process are used in medical practices or hospitals – and this approval process usually has to be renewed every five years.

Deficiency with deadly consequences

Sounds like an attempt to protect the health and life of patients as best as possible, but in case of doubt it does not always have this effect – on the contrary.

Professor Nikolaus Haas is a pediatric cardiologist and specialist in congenital heart disease at the Munich University Hospital. For example, he names a so-called balloon catheter that he and his colleagues need. “We need a balloon like this so that we can carry out an operation in newborns in the incubator – to save a whole lot of children’s lives if a child is born with a specific heart defect,” explains Haas.

But the balloon catheters are currently in short supply because they are hardly ever certified and approved. “The result is that we have to use other products, we have to make do,” Haas continues:

Approval complicated and expensive for manufacturers

For many manufacturers of this special medical product, the approval procedure that applies in the EU is too complicated and too expensive. And that’s why, when in doubt, they prefer to forgo the approval and simply no longer offer it.

As with the balloon catheters, it is also the case with many other things that are necessary in everyday hospital life, says Haas. It’s about hoses, probes or prostheses – and the less often they are used, the greater the shortage. Because with comparatively small quantities in production, certification for production is practically no longer worthwhile, which is particularly noticeable in pediatric cardiology, for example.

CDU calls for a quick proposal for a simpler procedure

Peter Liese is a CDU health politician in the European Parliament. He views the situation with concern and wants the EU regulation to be amended quickly. Liese herself worked as a pediatrician many years ago and was repeatedly involved with the Heart Center in Bad Oeynhausen in North Rhine-Westphalia.

“I now have the feedback from Bad Oeynhausen that specific instruments for the treatment of children with heart disease are missing,” says Liese. This should not remain the case, which is why the EU Commission must quickly make a proposal to simplify the Medical Devices Regulation.

Exceptions for EU countries possible

The EU introduced the regulation in 2017 after the breast implants scandal, when some manufacturers used cheap industrial silicone for such implants – to the detriment of the health of thousands of women in Europe. But now, according to Liese, it is becoming clear that the regulation does not protect people better, but less.

After all: Until the regulation is adapted, member states can override it by means of an exemption in order to prevent dangerous shortage situations. Germany hasn’t done that yet.