The Medical Devices Regulations (MDR) in Germany

The medical technology sector in Germany is an important driver of the economical progress. On average, Medtech companies invest 9% of their turnover in research and development. The export share is 65%. The sector is characterized by small and medium-sized companies. 92% of companies have less than 250 employees. In total, the Medtech sector employs about 210.000 fte

The new EU Medical Devices Regulation has been implemented in May 2017. All manufacturers that plan to launch new products in Europe, have to expect dramatically increased requirements. The new regulatory scheme has a huge impact especially for small and medium-sized enterprises since also the certification of existing products needs to be updated. The  Medical Device Regulation (MDR) implement changes in each stage of the CE marking process, from the technical documentation, development, the clinical evaluation to certification, market surveillance and the product identification. 

But how will small and mid-sized Medtech companies and Start-up companies manage this situation?
What is clear is that companies need a longer financial breath to bring new products to the patient. This is also reflected in the results of the current autumn survey on the state of the medical technology industry, conducted by BVMed, the German industry association. The survey identifies the MDR as the biggest barrier to the technological progress.

In many places, the biggest change will affect clinical evaluation. In the future, it will be of greater significance, whereby evidence of safety and benefit will have to be proven in a clinical trial. This is especially true for high-risk devices in risk class III. Compared to other countries, Germany can build upon an excellent infrastructure which enables a cost-efficient implementation of clinical studies.

With the MDR, the requirements will increase, in particular for high-risk products within the medical device sector, which will lengthen the time required for the CE marking process.

Many small and medium-sized enterprises, as well as start-ups, should adjust their business strategies accordingly. Some examples are:

1. In the case of established products, companies want to benefit from the transitional periods as long as possible. 

2. While the MDR no longer allows a practicable solution for equivalence analysis with products already on the market, the US regulatory authority, the FDA, still allows this path by way of the 510k procedure for some products. This might lead to a situation where medical device companies might first try to conquer the US market before they bring innovation to Europe.

3. Some Market experts expect that in the future larger companies with more than 100 employees will be the only ones able to afford the research and development of such medical devices. The development costs and additional time loss resulting from the necessary clinical studies, which will involve increased regulatory effort and expense, will multiply and have to be financed by the companies themselves. But even the larger companies have to scrutinize their portfolio and see if the regulatory effort and expense is worthwhile or not.

In this changing and more demanding situation it is crucial to fully understand all regulatory requirements to successfully maneuver “dangerous waters”. 
Qserve has broad experience in Regulatory, Quality and Clinical Affairs. Our benchmark is the unique combination of a global reach, high-level expertise and staff with field experience. All consultants had former positions at medical device manufacturers, European Notified Bodies, US FDA or Chinese CFDA. We want to support manufacturers locally with a pragmatic approach and therefore decided to open an office in Germany to be closer to manufacturers in the German-speaking countries and support companies to continue to stay ahead of the regulatory changes. 

Medical technology companies of all sizes should familiarize themselves with the MDR as soon as possible and start a compliance program. The time until the end of the transition period in May 2020 is short, especially if clinical trials are needed to meet the new requirements.
If you understand the regulatory requirements like we do, it is a small step to make practical solutions making use of available data.

Stefan

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Stefan Menzl
Post date: April 26, 2018
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