The IVDR and MDR Are Changing How Healthcare Is Delivered

Although many of the requirements have existed previously, they have now been tightened and clarified, particularly with regard to in-house manufacturing. It is no longer sufficient to rely on best practices or historical interpretations and processes; instead, there are now requirements for technical documentation, risk management, quality systems, and traceability. For healthcare providers who modify, develop, or adapt products for internal use, this means more than just a change in regulations—it entails increased legal liability.

Regulatory expertise is becoming an integral part of the healthcare sector’s capacity for innovation, and this requires new ways of working, internal collaboration, and a systematic approach—whether at the regional level, in a university hospital, or at a specialized clinic.

When Healthcare Solutions Fall Under the Manufacturer's Liability

Many healthcare providers today are working to adapt, further develop, or create their own medical technology solutions to meet clinical needs where they feel the market falls short. This may involve a modified assistive device, software solutions, a proprietary analysis tool, or an in-house testing method in the laboratory. However, what is perceived as operational improvement work may, in fact, constitute manufacturing in the regulatory sense.

The MDR and IVDR make no distinction between manufacturers and healthcare providers who produce devices in-house when it comes to patient safety and the general requirements for safety and performance. However, the documentation and follow-up procedures may differ slightly.

Healthcare providers that manufacture medical devices which leave their own organization are subject to stricter manufacturing requirements; however, ultimate responsibility for patient safety applies regardless of whether the device leaves the organization or remains within the hospital.

Regulations as a Framework for Operational Management

Interpreting the MDR and IVDR as purely legal documents is to miss their strategic purpose. They are not written to hinder innovation, but to ensure that it is safe, traceable, and scalable. Therefore, they must also be interpreted in context: How do these regulations affect our existing workflows? What changes when we develop solutions ourselves? What skills need to be available at the intersection of clinical practice, technology, and administration?

Furthermore, the regulations are based on a life-cycle approach to safety, which means that responsibility does not end once a solution is put into use. For healthcare providers who develop or modify products themselves, this means that clinical data, performance evaluation, traceability, and documentation must not only be available but also be an integral part of their daily operations.

A shift that calls for a fresh start and offers leverage

The MDR and IVDR have not only clarified what it means to be a manufacturer; they have also redefined who actually qualifies as one. For healthcare providers, this means that in-house manufacturing is no longer an exception or a gray area, but a clearly defined responsibility. This shift requires a reorientation: a structured assessment of in-house solutions, systematic capacity building around ISO standards such as 13485 and 14971, and an integrated strategy for risk assessment, validation, and documentation.

Above all, however, it requires an organizational understanding that technological innovation in healthcare does not occur outside the regulatory framework, but within it.

Does this apply to us?

A common misconception is that the MDR and IVDR apply only to industrial manufacturers, but in practice, the regulations also cover healthcare providers who create their own solutions, adapt existing technology, or develop diagnostic methods for internal use for clinical purposes. It is not the commercial intent that determines compliance, but rather the actual responsibility for the product’s safety and documentation.

As a healthcare provider, you should consider the following:

• Do we use products we manufacture ourselves in our operations?
• Do we modify existing equipment or software to adapt it to our context?
• Do we have any internal development projects related to diagnostics, sensors, apps, or other medical technology applications?
• Do we operate a laboratory where we develop our own testing methods?
• Is there a clear division of responsibilities between clinical, technical, and administrative functions in these contexts?

If the answer to any of these questions is “yes,” it is likely that you are already operating within the scope of the manufacturer’s responsibilities as defined by the MDR and IVDR. This is a responsibility that arises from practice, not from a strategic decision. How it is integrated into the organization’s way of working thus becomes a critical management and operational issue.

Navigating this landscape is about building a long-term capacity to act with both precision and a holistic perspective. For healthcare providers operating at the intersection of use and development, between clinical practice and technology, the MDR and IVDR represent not only expanded requirements but also a new strategic responsibility. How this is managed going forward will impact innovation capacity, patient safety, and regulatory sustainability.

It’s a complex issue, but it doesn’t have to be solved on your own.
If you’d like to explore in more depth how the regulations affect your specific business, we’d be happy to continue the conversation in whatever way works best for you.