Medical devices and diagnostics are key components of modern and reliable healthcare. The medical technology sector is also an important part of the industrial healthcare industry in Europe. SMEs in particular play a key role here: around 93% of medtech companies are SMEs. They are often less visible, but in many cases are world market leaders and drivers of innovation in their specialist field. "Our SMEs make an indispensable contribution to the healthcare sector and are also an important job engine," say BVMed and VDGH. "We therefore support the EU Commission's announcement to take targeted measures to strengthen the competitiveness of European industry with a special focus on SMEs."
To this end, the two MedTech associations are proposing concrete measures in five fields of action:
1. updating the SME definition and creating the "mid-cap" category
The current SME criteria were established in 2003 and have not been adjusted since. Taking into account inflation for the period 2003 to 2024, BVMed and VDGH propose raising the threshold values for annual turnover and annual balance sheet by 57 percent. In addition, two further company categories ("small mid-cap" and "mid-cap") with corresponding thresholds should be introduced, which are larger than SMEs but smaller than large companies. These companies with up to 3,000 employees should benefit from simplifications in the legislation in the same way as SMEs. In future, the thresholds should be updated every five years.
2. strengthen the representation of SMEs in Europe
BVMed and VDGH are calling for a high-ranking SME representative to represent the interests of SMEs, who should be based directly with the President of the EU Commission. This person should be equipped with the necessary authority to reduce bureaucracy. In addition, the SME voice in the "Medical Devices Coordination Group" (MDCG7) should be included in a much more targeted manner through permanent representation.
3. give greater consideration to SME interests in legislative procedures
The two MedTech associations BVMed and VDGH advocate an SME impact assessment and appropriate regulations in EU legislation. This is because, in practice, the implementation of regulatory requirements often results in higher overall burdens for SMEs. It is also important to reduce reporting obligations for SMEs if the requirements cannot be met with reasonable effort or if SMEs are at a disadvantage compared to larger companies.
4. support measures for SMEs for certification costs
In the USA, there is a centrally controlled reduction in fees for SMEs by the federal authority FDA. A reduction in certification fees for SMEs also makes sense in the EU, but must be regulated differently due to the decentralized structures. BVMed and VDGH advocate that companies should be able to register as SMEs with a central EU authority. By classifying as an SME, this would fulfill the requirements for MDR/IVDR certification costs to be reimbursed on a pro rata basis through unbureaucratic EU funding measures in the form of grants. This process should be as streamlined as possible and be limited to proof of the number of employees and annual turnover.
5 Fair opportunities for SMEs in public tenders
BVMed and VDGH also see a need for improvement in the public procurement process. Tenders should be designed in such a way that they promote innovation, prioritize quality aspects over costs and avoid unnecessary bureaucracy. An EU-wide digital procurement platform should be created to promote harmonization and reduce the administrative burden.
"SMEs in the medical technology sector are drivers of innovation and the heart of the industry. We must support them and focus more on them, especially in legislative procedures at European level, in order to strengthen Europe as a business location," say the two Managing Directors Dr. Marc-Pierre Möll and Dr. Martin Walger.
With the position paper, VDGH and BVMed are sending a clear signal to the European Commission: The competitiveness of the medtech industry depends to a large extent on how medium-sized structures are taken into account in legislation. The EU is now called upon to back up its announcements on strengthening SMEs with concrete measures.
The detailed SME position paper can be downloaded at www.bvmed.de/kmu-position and www.vdgh.de/kmu-position can be downloaded.
The German Medical Technology Association (BVMed) BVMed represents over 300 manufacturers and suppliers in the medical technology industry, providers of medical aids and homecare providers, as well as the medical specialist and wholesale trade. In 2024, the medical technology industry (manufacturers of medical devices and medical products including micro-enterprises) employed a total of 212,100 people in Germany and generated gross value added of 19.7 billion euros, according to the WifOR Institute's Health Economic Accounts (GGR). According to economic statistics, there were 1,510 medical technology manufacturers with more than 20 employees in Germany in 2024, generating a total turnover of over 41 billion euros (55 billion euros with micro-enterprises). 68% of medical technology turnover comes from international business. Around 9 percent of turnover is invested in research and development. 93 percent of the companies are SMEs.
As a trade association, the German Diagnostics Industry Association (VDGH) represents the interests of more than 100 companies operating in Germany with a total turnover of 6.2 billion euros in 2024. They manufacture examination systems and reagents for the diagnosis of human diseases, which generate a turnover of more than 2.4 billion euros, as well as instruments, reagents, test systems and consumables for research in the life sciences, which generate a turnover of 3.8 billion euros.
BVMed media contact:
Manfred C. Beeres | Head of Communications, Press Spokesman
beeres@bvmed.de | +49 172 615 7426 | www.bvmed.de
VDGH media contact:
Torsten Kiesner | Head of Press and Communications
kiesner@vdgh.de | +49 30 2005 99-43 | www.vdgh.de
