Unlocking the Power of Post Market Clinical Follow Up for Orthopaedic Devices with Eclevar
Post-market clinical follow-up, usually shortened to PMCF, has become a central pillar of evidence generation under the European Union Medical Device Regulation. Under this legislation, all orthopaedic implants must be continually assessed after they reach the market to confirm that they continue to perform as intended and remain safe to use in the real-world setting. There is often a tendency to view PMCF as a one-off exercise carried out only to meet regulatory requirements. The real need is to design PMCF in the most effective way for both the manufacturer and the patient, so that implants can continue to be used with confidence on both sides.
Why regulatory pathway for Orthopaedics devices Is Different?
There is no separate pathway for orthopaedic devices under the EU MDR. The same framework applies, but its practical application is more stringent for these implants because of their higher risk profile. Orthopaedic implants are invasive and remain in the body for many years. They face cyclic loads across varied anatomies and activity levels, so important risks can emerge late in real-world use. This is why PMCF is defined in Annex XIV as a continuous process that keeps the clinical evaluation up to date beyond pre-market studies. When PMCF has been weak in orthopaedics the consequences have been serious, as seen with the 2010 metal-on-metal hip recall by DePuy and the 2015 Zimmer Persona Trabecular Metal tibial plate recall, both linked to early failures and costly revisions.
Five Persistent Challenges
Challenge 1: Long Observation Windows
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.
Challenge 2: Fragmented Clinical Data Sources
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.
Challenge 3: Variability in Global Practice
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.
Challenge 4: Regulatory scrutiny of methodology
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 DR .
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.
Challenge 5: Sustained Patient Engagement
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.
A Modern Framework for PMCF Success in Orthopaedics
Manufacturers who fail to plan PMCF carefully risk missing safety signals that only appear years later, leading to recalls, regulatory setbacks, and lasting damage to reputation. A forward-thinking approach treats PMCF as a continuous learning loop, balancing investment with efficiency while protecting both patients and the brand. The process begins with a gap analysis that maps every safety and performance claim to the available evidence. Where gaps remain, targeted activities are designed to close them:
- Registry surveillance provides broad coverage at relatively low cost, tracking revision events, infections, and survivorship across large populations.
- Prospective cohorts add depth by capturing PROMs, mobility indices, imaging, and wearable sensor data from focused patient groups.
- Digital platforms unify these streams in real time, reducing manual workload and creating dashboards that highlight anomalies before revision rates rise.
- Adaptive analytics convert raw inputs into actionable insights that feed directly into risk management, instructions for use, and future design refinements.
How Eclevar Medtech Unlocks Value for Orthopaedic Manufacturers
Strategic design
Eclevar Medtech’s regulatory and PMCF experts work with practising orthopaedic surgeons to define study objectives that meet both compliance and business needs. Sample size calculations are guided by benchmarks from European and international registries, ensuring designs are defensible and aligned with Notified Body expectations. The manufacturer retains overall responsibility as the study sponsor, while Eclevar provides the design expertise.
Regulatory navigation
Eclevar interprets MDR Annex XIV and MDCG guidance and translates them into clear, practical steps for the manufacturer. Drawing on experience as former Notified Body reviewers, the team manages ethics submissions and addresses NB queries on the sponsor’s behalf, ensuring fast and precise responses.
Clinical data capture
Through the partnership with Milo Health, manufacturers deploy a secure cloud platform to capture patient-reported outcomes, imaging metadata, and wearable sensor feeds. Eclevar sets up and oversees the capture process, while Milo Health provides the technology backbone. Automated checks within the platform flag missing or inconsistent entries so study teams can correct them quickly.
Real world linkage
Eclevar manages the integration of PMCF study records with external data sources under agreements and ethical approvals. This includes national joint registries, hospital discharge data, device identifier files, and payer claims. All linkages are handled in compliance with privacy law and local ethics. Where direct linkage is not possible, Eclevar coordinates structured surgeon surveys and follow-up calls to close evidence gaps.
Analytics and visualisation
Data collected and unified through Milo Health are transformed into interactive dashboards configured by Eclevar. These dashboards show survival curves, implant migration trends, and site-level performance, making outliers easy to detect. From the same system, manufacturers can generate regulator-ready reports that translate evidence into insights for risk management, IFUs, and design refinements.
A Proven Track Record
Eclevar has delivered PMCF programmes across a wide range of medical device technologies, helping manufacturers secure MDR renewals, expand indications, and enter new markets. With the addition of practising orthopaedic expertise to the team, this structured approach is now directly applied to implants and joint systems. By combining frontline clinical knowledge with regulatory insight and digital data capture, Eclevar is positioned to help orthopaedic manufacturers generate the robust evidence needed to demonstrate safety, performance, and long-term value.
Conclusion
PMCF for orthopaedic implants is complex but also profoundly valuable. When planned well, it moves beyond a regulatory obligation and becomes a living knowledge system that protects patients, supports surgeons, and drives sustainable growth for manufacturers. With regulatory expertise, digital capabilities, and orthopaedic insight, Eclevar is ready to partner with innovators across the full product lifecycle, ensuring that every implant delivers durable outcomes for many years to come.
Unlocking the Power of Post Market Clinical Follow Up for Orthopaedic Devices with Eclevar
Post-market clinical follow-up, usually shortened to PMCF, has become a central pillar of evidence generation under the European Union Medical Device Regulation. Under this legislation, all orthopaedic implants must be continually assessed after they reach the market to confirm that they continue to perform as intended and remain safe to use in the real-world setting. There is often a tendency to view PMCF as a one-off exercise carried out only to meet regulatory requirements. The real need is to design PMCF in the most effective way for both the manufacturer and the patient, so that implants can continue to be used with confidence on both sides.
Why regulatory pathway for Orthopaedics devices Is Different?
There is no separate pathway for orthopaedic devices under the EU MDR. The same framework applies, but its practical application is more stringent for these implants because of their higher risk profile. Orthopaedic implants are invasive and remain in the body for many years. They face cyclic loads across varied anatomies and activity levels, so important risks can emerge late in real-world use. This is why PMCF is defined in Annex XIV as a continuous process that keeps the clinical evaluation up to date beyond pre-market studies. When PMCF has been weak in orthopaedics the consequences have been serious, as seen with the 2010 metal-on-metal hip recall by DePuy and the 2015 Zimmer Persona Trabecular Metal tibial plate recall, both linked to early failures and costly revisions.
Five Persistent Challenges
Challenge 1: Long Observation Windows
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.
Challenge 2: Fragmented Clinical Data Sources
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.
Challenge 3: Variability in Global Practice
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.
Challenge 4: Regulatory scrutiny of methodology
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 DR .
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.
Challenge 5: Sustained Patient Engagement
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.
A Modern Framework for PMCF Success in Orthopaedics
Manufacturers who fail to plan PMCF carefully risk missing safety signals that only appear years later, leading to recalls, regulatory setbacks, and lasting damage to reputation. A forward-thinking approach treats PMCF as a continuous learning loop, balancing investment with efficiency while protecting both patients and the brand. The process begins with a gap analysis that maps every safety and performance claim to the available evidence. Where gaps remain, targeted activities are designed to close them:
- Registry surveillance provides broad coverage at relatively low cost, tracking revision events, infections, and survivorship across large populations.
- Prospective cohorts add depth by capturing PROMs, mobility indices, imaging, and wearable sensor data from focused patient groups.
- Digital platforms unify these streams in real time, reducing manual workload and creating dashboards that highlight anomalies before revision rates rise.
- Adaptive analytics convert raw inputs into actionable insights that feed directly into risk management, instructions for use, and future design refinements.
How Eclevar Medtech Unlocks Value for Orthopaedic Manufacturers
Strategic design
Eclevar Medtech’s regulatory and PMCF experts work with practising orthopaedic surgeons to define study objectives that meet both compliance and business needs. Sample size calculations are guided by benchmarks from European and international registries, ensuring designs are defensible and aligned with Notified Body expectations. The manufacturer retains overall responsibility as the study sponsor, while Eclevar provides the design expertise.
Regulatory navigation
Eclevar interprets MDR Annex XIV and MDCG guidance and translates them into clear, practical steps for the manufacturer. Drawing on experience as former Notified Body reviewers, the team manages ethics submissions and addresses NB queries on the sponsor’s behalf, ensuring fast and precise responses.
Clinical data capture
Through the partnership with Milo Health, manufacturers deploy a secure cloud platform to capture patient-reported outcomes, imaging metadata, and wearable sensor feeds. Eclevar sets up and oversees the capture process, while Milo Health provides the technology backbone. Automated checks within the platform flag missing or inconsistent entries so study teams can correct them quickly.
Real world linkage
Eclevar manages the integration of PMCF study records with external data sources under agreements and ethical approvals. This includes national joint registries, hospital discharge data, device identifier files, and payer claims. All linkages are handled in compliance with privacy law and local ethics. Where direct linkage is not possible, Eclevar coordinates structured surgeon surveys and follow-up calls to close evidence gaps.
Analytics and visualisation
Data collected and unified through Milo Health are transformed into interactive dashboards configured by Eclevar. These dashboards show survival curves, implant migration trends, and site-level performance, making outliers easy to detect. From the same system, manufacturers can generate regulator-ready reports that translate evidence into insights for risk management, IFUs, and design refinements.
A Proven Track Record
Eclevar has delivered PMCF programmes across a wide range of medical device technologies, helping manufacturers secure MDR renewals, expand indications, and enter new markets. With the addition of practising orthopaedic expertise to the team, this structured approach is now directly applied to implants and joint systems. By combining frontline clinical knowledge with regulatory insight and digital data capture, Eclevar is positioned to help orthopaedic manufacturers generate the robust evidence needed to demonstrate safety, performance, and long-term value.
Conclusion
PMCF for orthopaedic implants is complex but also profoundly valuable. When planned well, it moves beyond a regulatory obligation and becomes a living knowledge system that protects patients, supports surgeons, and drives sustainable growth for manufacturers. With regulatory expertise, digital capabilities, and orthopaedic insight, Eclevar is ready to partner with innovators across the full product lifecycle, ensuring that every implant delivers durable outcomes for many years to come.
