Why MDR Certification Matters & Lessons from moveUP’s Journey
In digital health, trust is everything. Whether you’re a patient recovering going through a treatment for a chronic condition, a clinician overseeing recovery after a surgical intervention, or a hospital evaluating new tools, you want to know: is the tech safe? Is it effective? Is it compliant with the latest regulations?
One perspective to answer these questions is MDR (Medical Device Regulation) certification.
moveUP’s Certifications at a Glance
- MDR Certification (Class IIa)
moveUP’s platform is MDR certified for medical device applications related to Knee Arthroplasty, Hip Arthroplasty, COPD and obesity surgery. This confirms that our solution meets the stricter safety, performance, and post-market requirements introduced under the new MDR framework.
- MDD Certification (Class I)
Medical device applications running on the moveUP platform in other domains remain certified under MDD certification (Medical Device Directive). This ensures ongoing compliance while we complete the transition to MDR across all applicable modules.
- Non-Medical Device Applications
moveUP also supports non-medical device use cases. These remain outside the scope of MDR/MDD but follow the same rigorous internal quality, privacy, and security standards.
MDR vs. MDD – What’s Changed
The European Medical Device Regulation (MDR) replaced the older Medical Device Directive (MDD). MDR imposes stricter requirements for:
- Safety and performance
- Clinical evaluation and evidence
- Post-market surveillance
- Data protection and cybersecurity
- Risk management and transparency
Any digital health solution marketed in the EU and making medical claims generally needs to comply with MDR.
Current Transition Timelines
The EU has introduced staggered transition deadlines to allow companies to move from MDD to MDR:
- Class IIa, IIb and III devices under valid MDD certificates can continue to be placed on the market until 31 December 2027 if certain conditions are met (no significant design changes, quality systems maintained, notified body involved).
- Class I devices that up-classify under MDR have until 31 December 2028 under similar conditions.
In practice, this means manufacturers like moveUP must maintain their MDD certificates while progressively obtaining MDR certification for each intended use.
moveUP’s MDR Journey
Our journey shows what it takes:
- 2017: Initial clinical research (mHealth study) with ~200 knee and hip arthroplasty patients validated safety and effectiveness.
- Since 2017: CE marking under MDD.
- Since 2019: ISO 13485 certified (quality management for medical devices).
- Since 2020: ISO 27001 certified (information security).
- 2022–2023: MDR audit stages, additional clinical studies (prospective, randomized, real-world) validating outcomes in knee and hip arthroplasty, COPD, and obesity surgery.
- 2025: Achieved MDR Class IIa certification for these indications; continuing to maintain MDD Class I certification for other uses and in full MDR transition before the EU deadlines.
What This Means for Patients, Clinicians, and Hospitals
- Safety & Effectiveness: MDR certification signals that the moveUP platform has been rigorously assessed for clinical benefit and risk management.
- Ongoing Compliance: Our certification ensures continuity and regulatory compliance.
- Future-Proofing: We’re actively aligning all relevant applications of our platform with MDR to meet the upcoming 2027/2028 deadlines.
Lessons for Other Digital Health Tools
- Start with strong clinical evidence in each application.
- Implement robust quality and software lifecycle processes early (ISO 13485, IEC 62304).
- Bake in data protection and cybersecurity from the start (ISO 27001, GDPR).
- Plan for MDR audits, ongoing post-market surveillance, and recertification.
Takeaway
For any digital health tool, MDR compliance is more than a legal checkbox — it’s a signal of trust, safety, and effectiveness.
moveUP’s journey shows that with careful planning, clinical evidence, and rigorous quality systems, it’s possible to meet MDR’s higher bar while continuing to innovate and deliver real patient benefits.