The burdens that small and medium-sized companies are currently facing when implementing the EU-MDR and the corona pandemic were discussed in BVMed's online medium-sized companies forum.
The topic of the EU Medical Devices Regulation is currently at the top of the agenda for many medtech companies, but the corona pandemic also poses many challenges for the industry. Medium-sized companies in particular have to struggle with this double burden: on the one hand due to the financial effects of the corona pandemic, for example due to postponed operations, on the other hand due to the completely new legal framework of the EU-MDR, which will apply from May 26, 2021. Against this background, many players in the industry are now campaigning for simplifications. The state government of Baden-Württemberg has just sent an appeal to Berlin and Brussels to start a structured dialogue about possible steps that can be taken and to implement simplifications for the industry in a timely manner.
Exchange at the Mittelstandsforum
The BVMed business association also sees a lot of potential here. "Our medical technology SMEs need more support and pragmatic solutions here," said BVMed Managing Director Marc-Pierre Möll at the digital BVMed SME forum, which took place on March 80, 11 with around 2021 companies. Philipp Birkenmaier from the Federal Ministry of Economics promised support with pragmatic solutions, for example with the possibility of virtual MDR audits. "In the BMWi we are ready to fight for such pragmatic solutions, especially for medtech SMEs," says Birkenmaier at BVMed.
BVMed is convinced that small and medium-sized companies in particular need support. “The medical technology industry is strongly characterized by medium-sized companies. Around 93 percent of medical technology companies employ fewer than 250 people,” says BVMed Managing Director Möll. Last but not least, against this background, BVMed founded a “SME and economic policy” department in 2019 in order to focus the association’s work on medium-sized medtech companies and their special interests and challenges and to create new service offerings. The presentation will be headed by Clara Allonge, who organized and moderated the BVMed SME forum this year.
BMWi pledges support to SMEs
At the event, Philipp Birkenmaier, Head of the SME Strategy Working Group (AstMi) at the BMWi, highlighted the economic policy challenges for medium-sized medical technology companies caused by the EU-MDR and the Corona Pandemic. He described the medical technology industry as an "important factor in the German economy" and he also sees the double burden of the new legal framework and the pandemic. “You have to do justice to this double burden. We need pragmatic solutions for small and medium-sized businesses," says Birkenmaier.
Christina Ziegenberg, deputy managing director and head of the Regulatory Affairs department at BVMed, addressed the SME-specific risks involved in implementing the MDR. The start of application of the EU regulation has been postponed by one year to May 2021, but the end of the transition period in May 2024 and the end of the sell-off period in May 2025 have remained the same. There are currently 19 notified bodies, "that's still not enough," says Ziegenberg. At the present time, only 5 of 50 possible legal acts have been issued by the EU Commission. There will also be no harmonized standards when they come into force. The expert committees are not yet operational. In addition, there are delays in EUDAMED, the digital backbone of MDR. The problem for medium-sized medical technology companies: The requirements and costs are increasing more and more without being compensated for. The biggest expense driver is the re-certification of existing products. "Particularly affected are niche and special suppliers with small quantities," says the BVMed expert. In addition, there are the financial effects of the corona pandemic and the associated lack of resources to implement the MDR. This creates a hindrance to the ability to innovate, which politics must have on the screen. Experts see a major challenge, especially in the coming years, when further bottlenecks become apparent.
Source: Press release medtech-zwo from March 12.03.2021th, XNUMX