Since 26 May 2021, the EU’s new MDR (Medical Device Regulation, 2017/745) applies. The MDR also applies not only to new products but also to seemingly safe products that have been around for decades.
The idea was that it would ensure the safety and performance of medical devices and thereby increase patient safety. But at the same time, the regulation would enable innovations. Was it then?
A difficult task
As so often, the idea was good and it is certainly not an easy task to create a regulatory framework for almost 30 countries if one counts the EEA countries that have also acceded to the regulation.
Meant well but overshot the marks?
Caused, among other things, by the scandal with unhealthy breast implants, the EU wanted to create clear rules. Hard work followed but the question is if the creators of the new rules did’nt overshoot the marks.
Development costs money and takes time. And finally, there must be a product that someone can earn a penny on, among other things to be able to develop the next innovative product – or further develop the existing one.
Here are some examples where MDR’s new, well-meaning, requirements unfortunately cause major problems in a number of medical areas.
Costs limit development
Brigitte Stiller is a professor of pediatric cardiology (heart functions and diseases in child health care) and treats both premature babies and infants. Some of these are born with congenital heart defects and need special heart catheters. As you can easily understand, these need to be extremely small; for a premature baby of approx. 2 kg, the vessels in the groin or neck are barely two millimeters in diameter.
And it is in these places that one inserts and transports individually adapted stents (expanded metal cylinders filled with a balloon) which in the right place in the heart can open and widen narrow sections and thus save the life of the patient.
Together with a small company, the professor developed a stent that can grow with the child. The advantage: you do not have to change the stent through an open heart operation with great risks, but can go into an artery to dilate the stent further with a balloon.
This product would significantly reduce the risk and provide better chances of survival. Would.
As there are not many such interventions, it is simply not profitable to drive the development further. The costs and time frame for hopefully getting an approved product after many sub-steps according to MDR are simply not reasonable.
Professor Wolfram Lamadé is a specialist in abdominal surgery. He was successfully developing a type of tissue adhesive that prevents the contents of the pancreas from attacking surrounding organs during surgery. The usual state of the art treatment is that the secretion is led away to the stomach or small intestine, which is difficult and can be life-threatening.
After a number of successful attempts, the industrial partner, a company with a turnover of billions, backed out, because the financial risk is too great now.
“No one dares to invest in a certification anymore,” says Lamadé, shaking his head.
The same requirements for proven products
But as said, the MDR applies not only to new products but also to existing ones.
What applies to the new development of products can also be seen as a mirror image of existing products. Conformity is not declared for the life of the product but must be regularly re-proven.
With EU-MDR, the requirements for documentation and evidence have also been significantly tightened here – even though a product has been on the market for decades without any changes or incidents. “Manufacturers think twice before deciding to certify the product and especially when it comes to products with limited uses in correspondingly low quantities,” says Yvonne Glienke at Medical Mountains.
The children’s needs are not met
Professor Oliver Muensterer, who runs a pediatric surgery clinic in Munich, gives an example of what has already happened to existing products that are no longer available.
“Until recently, we had a whole arsenal of instruments of different sizes for pediatric surgery from one manufacturer,” he says. “Suddenly, only one standard size was available. The trend is towards products that can be used for both children and adults. Half a millimeter does not seem like much at first, “but it makes a big difference if a baby is operated on with a 3.5 or 3.0 millimeter wide instrument.”
The situation is similar for wound-closing staplers. In the USA, a product with a diameter of five millimeters was launched especially for children – the development of a similar product in Europe was stopped. The calculation does not add up for the manufacturer.
New developments, especially in pediatric surgery, are now significantly hampered. “I can already see us operating like two generations ago,” says Muensterer. “It’s like going back to the Stone Age.”
Priority patient protection – but at the expense of what?
MDR’s new rules mean that it has become more time-consuming and at least twice as expensive to bring new medical technology products to market. Among other things, manufacturers must collect and document more data, provide evidence and – depending on the risk class and degree of innovation – conduct clinical evalutations.
Patient protection always and without a doubt has the highest priority, ”says Julia Steckeler from Medical Mountains. “But if patient protection is at the expense of progressive patient and supply security, then something is wrong with the system.”
Medical Mountains is based in Tuttlingen, in southern Germany. The city is known as “the world center of medical technology”. Over 300 companies manufacture surgical instruments, implants, endoscopes and other medical devices here. “Research and development have been significantly curtailed because there is no clarity about whether investments in innovations will pay off at some point,” says Steckeler’s colleague Yvonne Glienke.
Competitor USA: once approved, always approved
“In the case of existing special products, the cost of a renewed approval can amount to hundreds of thousands of Euros,” says Nikolaus Haas, chairman of the German Association of Pediatric Cardiology and Congenital Heart Disorders.
“Companies in the United States do not have to do this because the principle there is: once approved, always approved. This means a very unequal treatment and a distortion of the market. One consequence is that if products from a German or European manufacturer are withdrawn from the market, they will be replaced by American ones. These can easily cost ten times as much.
In the absence of proven products, pediatric surgery and other areas ar developing backwards, back to ‘old’, riskier methods”, he confirms Oliver Muensterer’s assessment.
For example, in pediatric cardiology, there was a special balloon catheter that had been used around the world for decades to save the lives of newborns with a special heart defect. “This catheter is no longer available because it is no longer profitable for the US company. The result: many children have died because there is no comparable product on the market. “It is five past twelve,” says Nikolaus Haas, calling the situation a minor disaster.
Not the fault of the Medtech companies
The four doctors agree that it is not possible to blame the medical technology companies. But the MDR regulation makes the development of economically viable innovative concepts increasingly difficult.
“Society must ask itself whether it is morally justified not to allow innovations,” says Oliver Muensterer, clarifying the scope and expressing his disappointment: “If we can operate on a child and everything goes smoothly, it may have 70 or 80 good years to live ahead. But if there is a lack of new, improved or even already established instruments, there are consequential costs for health care – not to mention the individual’s loss of quality of life. But these long-term consequences are simply not taken into account enough. In other words, a structuring of the regulations now and in such a way that innovations, especially in niche products, are again feasible, later pays off both materially and ethically.
However, this is counteracted by the ‘economic pressure’, according to Wolfram Lamadé, that is, the systematic requirement to make savings, which weighs on both manufacturers and doctors. “This causes more harm than good,” he said.
Role model USA: old rules for existing products
Julia Steckeler explains that there are already pragmatic solutions. In the USA, a country that places great emphasis on security, there are, for example, so-called ‘Grandfather clauses’ and ‘Pre-amendment Devices’. Simply put, the old rules continue to apply to products that were placed on the market before new rules were introduced.
“Such a system can also be transferred to existing products according to the EU MDR”, suggests Julia Steckeler, provided that there are no defects or serious changes in the product itself. Based on the FDA model, “Orphan Devices” can solve the problem of niche products through unique specifications for medical products manufactured in small numbers and for very special applications. In such cases, it would be conceivable to use CE marked instruments to gradually collect the clinical data required by the EU MDR. Otherwise, clinical evaluations must be initiated. And these costs exceed the profitability calculation for niche products. Then the development ends before it even starts, especially for small and medium-sized businesses.
Patience protection versus innovations
“If nothing changes, new products will either no longer be developed at all or they will be approved primarily or even exclusively in non-European markets,” concludes Julia Steckeler. Each of these aspects ultimately affects patient care across Europe.
Wolfram Lamadé goes one step further in his assessment. It is undisputed that control is needed and safety comes first. However, an obvious over-regulation of new products can no longer be argued away by citing patient protection. Restricting innovation results in death. “