Medical Devices Law – Significance, innovations and challenges for the industry

What is the Medical Devices Law (MDL)?

The Medical Devices Law (MDL) regulates the safety, quality and performance of medical devices in Germany. It was originally introduced in 1995 and was in force until it was replaced by the European Medical Device Regulation (MDR) in 2021. Nevertheless, it continues to play an important role, as many of the original requirements have been transferred to the MDR.

Medical devices cover a wide range of products, including

• Diagnostic devices and surgical instruments
• Implants, such as artificial joints or pacemakers
• Medical software, for example for imaging
• Dressings, catheters and many other products

Significance of the MDL for the pharmaceutical and healthcare industry

For decades, the MDL was a central set of regulations for companies in the pharmaceutical and healthcare industry. It defined the approval processes, risk classes and safety standards for medical devices to ensure the protection of patients and users.

Following the introduction of the Medical Device Regulation (MDR), the regulatory requirements have become considerably stricter. Pharmaceutical companies that develop combination products consisting of medicinal products and medical devices must now comply with stricter testing and documentation requirements. Among other things, this concerns clinical evaluation, in which scientific studies must prove that a medical device is safe and effective. Extensive technical documentation is also required, which includes detailed information on manufacturing, materials and risk assessments. In addition, companies must carry out post-market surveillance, i.e. ensure continuous monitoring of their products after market launch.

Medical Devices Law vs. Medical Devices Regulation (MDR)

With the introduction of the MDR, numerous changes were made to increase patient safety and ensure harmonization across Europe. The risk classification of products has been tightened, making many medical devices subject to stricter controls. In addition, a clinical evaluation is mandatory for almost all products, whereas this was not always necessary under the MDL.

Market surveillance has also been strengthened. While it was previously regulated at national level, it is now carried out EU-wide under the control of authorities. The transition periods for manufacturers are much stricter, which requires faster adaptation to new regulations. In addition, there is a clear UDI label that ensures greater transparency and enables better traceability of products.

Effects on companies and market approval

For manufacturers of medical devices, the new MDR regulation means, among other things, longer time-to-market as the testing procedures are stricter. There are also higher costs for clinical studies and certifications, which is a challenge for smaller companies in particular. The documentation effort has also increased, especially for existing products that have already been approved under the Medical Devices Law.

Many companies have had to adapt their strategy to meet the new requirements. While large pharmaceutical and medical technology companies often have existing compliance structures, smaller and medium-sized companies face considerable bureaucratic hurdles.

The future of Medical Device Regulation

The regulation of medical devices will continue to evolve in the coming years. Digitalization in particular will play a decisive role. The use of artificial intelligence (AI) and big data in medical devices requires new standards. In addition, the European database for medical devices (EUDAMED) will play a central role in market surveillance.

Legislators are also working to create more flexible regulations for disruptive technologies such as digital health applications in order to promote innovation without jeopardizing patient safety.

Conclusion: Challenges and opportunities for the industry

For many years, the Medical Devices Law (MDL) has laid the foundation for safe medical devices. With the introduction of the MDR, the requirements have increased, but at the same time new opportunities have arisen for companies that adapt at an early stage.

The main challenges are the increased effort for certifications, rising costs and stricter regulations. At the same time, there are opportunities through improved product safety, greater transparency and a uniform EU market. Companies that adapt well to the new regulatory framework can secure long-term competitive advantages and further strengthen the trust of patients and professionals.