Belgium, (Brussels Morning Newspaper) Medical associations, experts and companies are criticising EU rules aimed at preventing health scandals that came into effect last year.
The EU Medical Devices Regulation (MDR) introduced stricter safety criteria in May 2021, requiring producers of some medical devices to launch new clinical trials, according to Reuters reporting on Monday.
This is affecting smaller companies and manufacturers, with some warning that they had to stop making devices or withdraw them from the EU market because they do not have enough money to comply with new rules.
According to eight manufacturers, new rules have stretched the time required for certification of products from several months to up to more than two years.
In addition, the cost of certification has increased threefold to tenfold, with manufacturers warning that they are forced to allow certification of some products to expire, which leaves hospitals unable to use them.
The EC commented on the issue, pledging to do whatever it can to make sure that patients in the EU have access to medical devices.
Negative effects
The Standing Committee of European Doctors (CPME) warned about shortages of medical devices in hospitals in Austria and Denmark.
The French National Agency for the Safety of Medicines and Health Products (ANSM) added that the national healthcare system is facing shortages, in part due to new EU rules.
Nicola Osypka, head of a small German company, pointed out “we cannot afford half a million euro it takes to conduct a clinical study,” stressing that new rules are pushing off the market “products that have been on the market for 30 or 40 years.”
She added that new rules are preventing smaller companies from innovating as costs are prohibitively high, even for products that previously passed clinical trials.
The EC attempted to address the problem earlier this month, proposing to push back the deadline for compliance with new rules from 2024 to 2028 and expressing hope that the move would prevent shortages.
The proposal needs to be approved by EU Parliament and Council before it can come into effect.
Frank Matzek, head of regulatory and government affairs at German medical devices manufacturer Biotronik, pointed out that the proposed delay would not solve the problem.
He noted that the newly increased cost of innovation and doing business remains an obstacle to smaller companies.
