The German Medical Technology Association, BVMed for short, warns against the implementation of the EU Medical Device Regulation (EU MDR) and the financial impact of the Corona pandemic on small and medium-sized enterprises (SMEs).
The double burden for the medical technology sector is too high to compensate for the new legal framework of the EU MDR at the same time as the negative financial effects of the Covid 19 pandemic, also because niche and specialty suppliers, with the production of particularly small quantities, are suffering in particular.
Although the new legal framework will not be legally effective until May 26, 2021, and its implementation will take another three years thereafter with a transition period, it is already clear that the MedTech industry needs support and pragmatic solutions, explains BVMed, which is making an appeal to politicians.
Philipp Birkenmaier, as head of the SME strategy working group at the German Federal Ministry of Economics (BMWi), is taking up the matter, partly because the state government of Baden-Württemberg is calling for a structured dialog and facilitation for the entire industry.
So-called virtual MDR audits are to help SMEs get out of the predicament. These investigation procedures will have to be used so that processes, requirements, and guidelines that are supposed to meet the required standard can be checked again.
The MedTech industry is dominated by small and medium-sized companies, as 93 percent of them have fewer than 250 employees and have to cope with the double burden. This is why BVMed is calling for relief. BVMed’s association work is also specifically tailored to SMEs, which urgently need new service offerings, such as the newly established „SME and Economic Policy“ department.
At the association’s SME forum, Christina Ziegenberg, deputy managing director at BVMed, also addressed the economic policy challenges facing the industry and explained the specific risks for small and medium-sized enterprises. She criticized above all the scarcity of the so-called Notified Bodies, currently only 19 in number, and delays in EUDAMED, the European medical device database, which is not fully operational. However, it is the basis for a large number of obligations, for example for manufacturers as well as for notified bodies. Additional work and delays are therefore associated with its central role, which also has a negative impact on the innovative capacity of MedTech companies.
Source: Medtech-Zwo