Compliance by design: Booster for the approval of medical devices

(Frankfurt a. M., 22.05.2025) At a time when medical technology is becoming increasingly intelligent, connected and complex, manufacturers are facing a growing challenge: how can innovation be reconciled with increasing regulatory requirements? In the face of increasing bureaucracy and regulation for medical devices, it is becoming clear that only those who take legal requirements into account from the outset can achieve a fast market launch, improved product quality and greater cost efficiency. Small and medium-sized enterprises (SMEs) in Germany in particular are coming under increasing pressure. Dr. Thorsten Prinz, spokesperson for the VDE DGBMT Regulatory Affairs Technical Committee, explains: "Due to their limited human and financial resources, SMEs only have one option for bringing their medical devices to the EU market despite the regulatory hurdles. They must identify and analyze the relevant regulatory requirements for their product at an early stage and incorporate them into the development process."

VDE DGBMT has now published the practical recommendation MD CoDe (Medical Device – Compliance by Design) to provide targeted support for medical technology manufacturers. It shows how compliance by design – i.e. the consistent integration of regulatory requirements directly into the development process – can be implemented efficiently and in a future-oriented manner.

Development with foresight: Practical example shows how manufacturers overcome regulatory hurdles early on

In addition to the stringent requirements of the EU Medical Device Regulation (MDR), medical technology manufacturers are now also confronted with the EU AI Act if they want to bring an AI system onto the EU market as a medical device or as a safety component of a medical device. "Companies are therefore well advised to introduce processes that identify the relevant legal requirements and apply them right from the start of product development," explains Prinz.

"To make it easier to understand the regulatory requirements, we explain how these can be met using a specific use case: In the EU project ThrombUS+, in which the VDE is involved among others, a complex medical device for the diagnosis and prevention of deep vein thrombosis is currently being developed. This system represents the ideal use case, as it contains both various hardware and software components, including AI models," says the VDE Health expert. This makes MD CoDe a practical aid, especially for start-ups that are developing a medical device for the first time. Manufacturers can use it to ensure that their products comply with regulatory requirements and that the development process is both innovative and efficient.

Cross-industry alliance for practice-oriented solution

Representatives from industry, research and notified bodies as well as experts from the VDE DGBMT Regulatory Affairs Technical Committee contributed to the new recommendation. "The experts have contributed their combined expertise and experience in implementing the compliance-by-design approach to MD CoDe," says Prinz.

The overarching aim is to support the medical technology industry and simplify the path from product to patient care. To this end, the VDE recommendation MD Comp (German version) on the safe integration of medical devices and non-medical devices and the VDE SPEC MD CRAFTS (Medical Devices - Risk Management: Framework of a Computerized Risk Analysis Format for Transmission and Submission) have already been published in recent years.

About the VDE recommendation MD CoDe

The VDE recommendation "MD CoDe – Compliance by Design as a key concept for meeting the European regulatory requirements for medical devices" resulted from the collaboration between the EU project ThrombUS+ and the VDE DGBMT Regulatory Affairs Technical Committee. It can be downloaded here free of charge.

About the German Society for Biomedical Engineering within VDE (VDE DGBMT)

The German Society for Biomedical Engineering within VDE (VDE DGBMT) is the scientific and technical society for medical technology in Germany. It was founded in Frankfurt am Main in 1961.  

The DGBMT in the VDE brings together experts from all areas of technology applications in medicine and deals with the entire range of topics in biomedical technology. It organizes conferences and workshops for expert audiences and is the sponsor of two international scientific journals: Biomedical Engineering and Current Directions in Biomedical Engineering published by Walter de Gruyter. Position papers, statements and expert contributions discuss current topics independently and neutrally. In addition, the DGBMT awards promotional prizes for young scientists, for scientific excellence and innovation, and for patient safety in biomedical engineering. Last but not least, it represents German biomedical engineering in international bodies.  

For more information, visit www.vde.com/dgbmt

About VDE

VDE, one of the largest technology organizations in Europe, has been regarded as a synonym for innovation and technological progress for more than 130 years. VDE is the only organization in the world that combines science, standardization, testing, certification, and application consulting under one umbrella. The VDE mark has been synonymous with the highest safety standards and consumer protection for more than 100 years. 

Our passion is the advancement of technology, the next generation of engineers and technologists, and lifelong learning and career development “on the job”. Within the VDE network more than 2,000 employees at over 60 locations worldwide, more than 100,000 honorary experts, and around 1,500 companies are dedicated to ensuring a future worth living: networked, digital, electrical.  
Shaping the e-dialistic future. 

The VDE (VDE Association for Electrical, Electronic & Information Technologies) is headquartered in Frankfurt am Main. For more information, visit www.vde.com