Don’t Get Left Behind: Why Medical Device Regulation (MDR) Compliance Is Critical for Care Providers in the EU
Healthcare is evolving fast – and so are the rules for the digital tools we trust every day. Before the end of 2027, Class III devices and implantable Class IIb devices must be fully compliant with the MDR to be legally placed on the market in the EU. With the MDR now in full force across the Netherlands, many care providers face a pressing question: Do your clinical software tools meet today’s safety and future-readiness standards? What does MDR mean, and why is it critical to pay attention now?
Platform24 is an MDR-compliant software company and will publish a four-part series about MDR regulations and what you need to consider when procuring an MDR or non-MDR solution.
What is MDR?
The Medical Device Regulation (MDR 2017/745) is the European Union’s regulatory framework for medical devices—including digital health software. In force since May 2021, MDR replaces previous rules (MDD) and introduces stricter requirements for safety, performance, and clinical evidence. Any software supporting clinical workflows, diagnostics, or decision-making can be classified as a medical device and must comply with MDR.
Why Should Care Providers Care About MDR?
As a care provider, you rely more than ever on digital solutions: from triage solutions and patient communication apps to telemedicine and clinical decision support. Under MDR, you have a legal and ethical responsibility to ensure the medical technology you use is compliant, up-to-date, and safe.
What Happens If You Ignore MDR?
- Non-MDR Software = No Regulatory Oversight:
Using software that isn’t MDR-certified means there’s no guarantee it meets EU safety standards. There is no external authority that has reviewed its quality, updates, or risk management. - Patient Safety & Service Continuity Risks:
Non-certified tools can introduce hidden risks—for patients and for your own operations. If problems emerge, you cannot rely on regulatory protections or support from the vendor. - No Safe Updates or Modifications:
Once MDR is in effect, non-compliant software cannot be legally updated, improved, or even patched. That means no security fixes, bug resolutions, or feature enhancements—leaving sensitive processes exposed. - No Room for Future Change:
The healthcare landscape is changing faster than ever. Non-MDR-compliant solutions cannot adapt to new regulations or needs, putting your organization at risk of falling behind and limiting your innovation potential.
What now?
MDR is not just a future consideration, it’s already here. Across the Netherlands and the EU, care providers are expected to verify that the health software they use is MDR-certified, properly documented, and audited by Notified Bodies. This is not just best practice – it’s the law.
Healthcare software vendors like Platform24 that have achieved MDR certification, ensure that their solutions continue to evolve, stay secure, and support safer care delivery.
How is Platform working with MDR?
The Swedish health tech company Platform24 is one of the first to receive an MDR certification for its products. An MDR certification is a lengthy and demanding process, and it also continues after the initial certification.
The CE marking indicates that the products comply with the requirements for medical equipment and can be marketed in the EU. The certification also enables expansion and development of the technical platform, which includes updates to the solutions and the addition of new functions. It also clarifies who is responsible for what during use, requirements for technical documentation, benefit-risk evaluation, clinical evaluation, and after-market monitoring. Platform24 has implemented necessary audits and continuous assessments of its products to achieve the MDR certification.
Bottom line
Choosing non-MDR-certified software exposes both patients and your healthcare organization to unnecessary—and avoidable—risks. Now is the time to review your digital toolkit and ensure every solution meets MDR. Your patients’ safety and your organization’s future depend on it!