Unlocking the Power of Post Market Clinical Follow Up for Orthopaedic Devices with Eclevar

The Challenge

Problems such as stiffness, pain, or loosening often take years to appear after an implant is placed. While patients may recover quickly at first, the true test is whether those improvements last a decade or more, which makes it hard for manufacturers to design timely PMCF programs.

The Implication

Regulators and payers still expect earlier confirmation of safety and performance, leaving a gap if manufacturers rely only on late outcomes.

Solution Pathways

Surrogate endpoints such as implant migration (RSA), national joint registries, digital monitoring with wearables, and imaging repositories can provide early signals while building the long-term evidence base.

The Challenge

Clinical evidence is scattered across different places. Registries capture revisions, hospitals store imaging, and patients enter PROMs into apps or digital tools that often do not connect back to hospital systems.

The Implication

Without bringing these data streams together, manufacturers end up with incomplete evidence that is difficult to present to regulators and slows the detection of safety or performance issues.

Solution Pathways

• Link registry data with hospital records so revision events can be understood in the context of imaging and patient symptoms.
• Use digital platforms that integrate PROMs directly into the same database, ensuring patient-reported outcomes sit alongside clinical findings.
• Provide coordinators and clinicians with simple dashboards that highlight missing follow-up data so gaps can be closed quickly.

The Challenge

Orthopaedic outcomes are strongly influenced not only by the implant but also by how it is used. Surgical approaches differ (cemented vs uncemented fixation, anterior vs posterior hip), rehabilitation protocols range from aggressive early mobilisation to slow recovery, and patient populations vary widely in age, weight, activity, and comorbidities.

The Implication

These variations make it difficult for manufacturers to interpret pooled PMCF data. A knee system that performs well in a Scandinavian registry may look very different in US or Asian settings if surgical technique or patient profile is not accounted for. Without stratification, true device performance can be hidden by regional or practice-based differences.

Solution Pathways

Design PMCF studies with pre-planned subgroup analyses by geography, surgical approach, and patient risk factors. Build investigator networks across regions to ensure data diversity. Use adaptive cohorts that capture under-represented groups, helping manufacturers understand not just if an implant works, but where and for whom it performs best.

The Challenge

For orthopaedic implants, which fall into the highest risk classes, Notified Bodies examine not just the outcomes but also the methods behind them. They expect predefined objectives that map directly to manufacturer claims in the clinical investigation plan or PMCF study protocol, a justified sample size that is transparent in the PMCF plan, and prespecified statistical methods clearly laid out in the clinical evaluation report (CER).

The Implication

If methods or documentation are weak, NBs request corrective actions, extra PMCF, or escalate reviews. Class III and implantable devices face additional ongoing scrutiny through annual PSURs, and certain high‑risk devices can trigger an expert panel consultation under Article 54 of the MDR.

Solution Pathways

Align claims, objectives, and endpoints before protocol finalisation, then justify sample size using reference rates from registries or literature, and prespecify subgroup and sensitivity analyses relevant to surgical technique and patient risk. Build the PMCF plan using the MDCG template, ensure the PMCF evaluation report closes the loop, and prepare an audit‑ready clinical evaluation package consistent with NB best‑practice guidance.

The Challenge

Once patients regain mobility and feel better, many stop attending follow-up visits. This leads to missing data at the very time when long-term evidence on implant safety and durability is most valuable.

The Implication

Drop-outs weaken the statistical power of PMCF studies and leave gaps in evidence. Notified Bodies often flag poor follow-up rates as a major weakness in orthopaedic submissions, since missing patients could hide early signs of implant failure.

Solution Pathways

• Combine clinic visits with remote options such as telehealth check-ins to reduce the burden on patients.
• Use digital tools (apps, SMS reminders, secure web portals) that let patients easily enter PROMs and symptom updates from home.
• Provide feedback dashboards showing progress (e.g. walking distance, pain score trends) so patients see value in continued participation.
• Partner with registries that run long-term follow-up, ensuring data continues to flow even if patients change hospitals.