Medical Device Regulation – A decelerator for the medical technology industry?

The European Medical Device Regulation (MDR) has been in force since May 26 2021. Since then, however, the MDR has not been well received. Due to the additional administrative work, development resources are tied up for the MDR, which in turn are lacking for important innovations as the latest Swiss Medtech Sector Study reveals.

Medical technology industry faces major challenges

The objective of the MDR is to improve levels of health protection – and therefore demands significantly higher requirements on clinical safety and product performance. This, however, leads primarily to higher costs and uncertainty regarding legal interpretation, as the Swiss Medtech Industry Sector Study shows. Many companies can hardly cope with the additional administrative and cost-intensive workload of the MDR and are forced to streamline their product portfolio. Available domestic data on the impact of MDR from Swiss Medtech are confirmed by a representative, Europe-wide survey published in July 2022 by the umbrella organisation Medtech Europe. According to this survey, 50 % of manufacturers across Europe said they would downsize their product portfolio due to the MDR; in Switzerland, the number is 60 %.

In view of the Swiss medtech industry, it can be stated that it remains robust despite many challenges such as the introduction of the MDR. This continued expansion is due to the significant efforts and flexibility of companies. New data from the Swiss Medtech Industry Sector Study show that the sector has created 4‘500 new jobs in Switzerland in the past two years. With a workforce of approximately 67,500 employees, the industry achieved a turnover of 20.8 billion Swiss francs in 2021. This is a growth of 7.6 % over the past two years. However, the environment remains challenging with the MDR leading to innovations falling behind and thus endangering the long-term growth of the industry.

SMEs struggle the most

Especially for Small and Medium Enterprises (SMEs), the MDR represents a major hurdle. They simply do not have the capacity for this additional administrative work. Therefore, between 15 % and 30 % still do not have access to an MDR-designated Notified Body. For SMEs, the progress to MDR certification is slower than average, as the Medtech Europe survey reveals.

How to overcome challenges of MDR

The current environment shows that the time span between product conception and market launch is more critical now than ever. A reliable OEM partner who is familiar with MDR regulations can help you speed up time-to-market in a cost-effective way and preserve competitive advantage. As a full solution provider, Brütsch Elektronik AG offers broad competence and professional project management out of one hand. We take responsibility throughout the entire lifecycle of your device – from development to industrialization and production to after-sales support. Get in touch if we can support you in the implementation of the MDR or browse our white paper to find out why a partnership with Brütsch Elektronik is even more worthwhile in times of MDR.

For more information, feel free to visit our medical technology site.