Annex XIV Part B requires every CE-marked medical device manufacturer to maintain a continuous Post-Market Clinical Follow-Up program. This hub covers the full PMCF landscape — from survey design to clinical investigations, registry integration, and the four therapeutic verticals Eclevar MedTech specialises in.
Not every PMCF program requires a clinical investigation. The right architecture depends on your device class, indication, and the unresolved data gaps in your CER. Eclevar designs PMCF programs that are defensible at Notified Body renewal — not just compliant on paper.
High-quality Level 4 PMCF surveys are the most cost-effective PMCF method for many Class IIa and IIb devices. To qualify as Level 4, surveys must use validated, disease-specific questionnaires, be conducted at clinical sites with confirmed device use, and be governed by a formal PMCF protocol with ethics committee oversight. Eclevar's survey platform — powered by MILO Health — delivers Annex XIV-mapped data capture from Day 1.
For devices requiring long-term real-world evidence beyond what surveys can provide, prospective observational PMCF studies offer a structured, multi-center approach without the intervention requirements of a pivotal trial. Eclevar manages observational programs across France, Germany, UK, Italy, and Spain — with full ISO 14155:2020 governance, in-house CRA monitoring, and MILO Health data capture.
National implant registries are increasingly the primary long-term PMCF data source for Class IIb and III implantable devices. Eclevar's registry strategy covers NJR (UK), EPRD (Germany), and Swespine (Sweden/Denmark) — with UDI linkage, EUDAMED registration, and MILO Health registry integration for seamless data reconciliation with the clinical study eCRF. Registry participation must be established at protocol design, not post-market.
A PMCF Plan without a direct gap-mapping to the CER is a non-conformity waiting to happen. Eclevar's medical writers — reviewed by former Notified Body assessors — produce PMCF Plans and Reports that are structured for Notified Body scrutiny from page one. Every plan includes a formal data gap table with explicit PMCF activity assignments, timeline, and success criteria aligned to the PSUR cycle.
Generic PMCF methodology does not survive Notified Body review in specialist therapeutic areas. Each vertical has specific endpoint standards, registry ecosystems, and clinical evidence expectations. Eclevar's teams are structured by vertical — not generalist.
Cardiovascular PMCF programs operate under the most demanding endpoint framework in EU MDR. Valve Academic Research Consortium (VARC-3) defines the mandatory composite endpoints for structural heart devices — any PMCF protocol deviating from VARC-3 without explicit justification will be challenged at Notified Body review. For TAVI and structural heart devices, the transition from Investigator-Initiated Studies (IIS) to formal PMCF programs is a critical regulatory moment — data collected under IIS without formal PMCF governance may not be accepted as PMCF evidence.
Eclevar's cardiovascular team manages multi-center PMCF programs across France, UK, Germany, and Italy, with in-house CRA monitoring and MILO Health EDC configured for VARC-3 endpoint capture, adjudication workflows, and MACE coding aligned with Notified Body expectations.
Wound care PMCF is complicated by the heterogeneity of patient populations — chronic diabetic foot ulcers, pressure injuries, and complex surgical wounds require different PMCF methodologies and endpoint frameworks. The European Wound Management Association (EWMA) clinical guidelines define the state-of-the-art against which your device's benefit-risk profile will be benchmarked. Eclevar's EWMA collaboration gives our wound care team direct access to the clinical leadership shaping these standards.
For NPWT systems, bioengineered tissue substitutes, and antimicrobial dressings, Eclevar designs Level 4 PMCF surveys with validated wound outcome instruments (PUSH tool, BWAT, Wound-QoL) and multi-center prospective observational programs with sites across France, UK, and Germany. Prof. Luc Teot leads our wound care clinical expert network.
For orthopedic and spine implants under EU MDR, registry-based PMCF is no longer optional for Class IIb and III devices — it is the expected architecture. The National Joint Registry (NJR, UK), the German Endoprothesen Register (EPRD), and Swespine collectively cover tens of millions of implant records and represent the most credible long-term evidence source available for joint reconstruction and spine fusion devices.
Led by Dr. Nikhil Khadabadi — former TUV SUD Senior Reviewer specialising in Class IIb/III implantable device clinical evidence — Eclevar's orthopedic practice covers NJR and EPRD registry linkage, radiographic measurement charter design, Annex XIV-compliant eCRF build for implant-specific data fields, and 10-year PMCF architectures for Class III AIMDs in robotics-assisted surgery.
Active Implantable Medical Devices (AIMDs) in the neuromodulation space — spinal cord stimulators (SCS), deep brain stimulators (DBS), cochlear implants, and peripheral nerve stimulation devices — face among the most rigorous PMCF requirements under EU MDR. Class III AIMD classification triggers mandatory 10-year PMCF follow-up, with annual reporting to EUDAMED and specific requirements for patient-reported outcome measures (PROMs) at every scheduled visit.
Eclevar's neuromodulation PMCF programs are designed for the full 10-year lifecycle — from PMCF protocol design through annual data collection, interim analysis, and PSUR reporting. MILO Health's long-term follow-up scheduling module automates visit windows, patient contact workflows, and missed visit escalation protocols across multi-country programs spanning up to a decade.
Reporting frequencies, key documents, and Notified Body expectations by device class. Based on EU MDR 2017/745, MDCG 2020-7, and current NB practice.
| Device class | PMCF activity requirement | PSUR / PMSR frequency | Key regulatory reference | Long-term follow-up |
|---|---|---|---|---|
| Class I | PMCF required if justified by the PMS plan. Often limited to structured literature monitoring and complaint analysis. | PMSR — as needed | EU MDR Art. 83 MDCG 2020-7 | Not typically required for non-sterile, non-measuring Class I. |
| Class IIa | Active PMCF required. High-quality Level 4 surveys typically sufficient if methodology is validated and site-based. | PMSR — periodic | Annex XIV Part B MDCG 2020-7 | Minimum 2–5 years for implantable Class IIa. |
| Class IIb | Robust PMCF program required. Surveys, observational studies, or registry participation based on data gap profile. NB expects documented gap-mapping. | PSUR — every 2 years | Annex XIV Part B EU MDR Art. 86 | 5+ years for implantable Class IIb. Registry integration expected. |
| Class III | Comprehensive PMCF program mandatory. Clinical investigations, registry linkage, or both. Notified Body scrutiny highest at this class. | PSUR — annually | EU MDR Art. 61 Annex XIV Parts A&B | 10 years for AIMDs. EUDAMED annual reporting mandatory. |
| Class III AIMD | Maximum scrutiny. 10-year PMCF architecture required from protocol design. EUDAMED registration, annual PSUR, SSCP update at each renewal. | PSUR — annually | EU MDR Art. 32 MDCG 2021-3 | 10 years mandatory. Patient contact workflow at every visit window. |
Compiled by Eclevar MedTech based on EU MDR 2017/745, MDCG 2020-7, and current Notified Body practice. Always verify against the primary regulatory documents. Last reviewed April 2026.
PMCF (Post-Market Clinical Follow-Up) is a continuous clinical data collection process required by EU MDR 2017/745 Annex XIV Part B for all CE-marked medical devices. It requires manufacturers to proactively collect post-market clinical data through structured activities — surveys, investigations, registry participation, or literature monitoring — to confirm the benefit-risk profile established at CE marking and address unresolved data gaps from the CER.
PMS (Post-Market Surveillance) is the overarching system for collecting and analysing post-market data — including complaints, vigilance reports, and literature monitoring. PMCF is the specifically clinical component of PMS: it requires proactive, structured clinical data collection. All PMCF findings feed into the PMS system, which informs the PSUR and triggers CER updates when conclusions change. PMCF cannot be replaced by reactive vigilance alone.
No. For many Class IIa and IIb devices, a high-quality Level 4 PMCF survey is sufficient — provided it uses validated, disease-specific instruments, is conducted at clinical sites with confirmed device use, and is governed by a formal PMCF protocol with ethics committee oversight. Clinical investigations become necessary when existing evidence is insufficient and survey data cannot address critical data gaps — typically for Class III devices or AIMDs with novel mechanisms.
The PMCF Plan must be reviewed as part of the annual CER update cycle for Class IIb and III devices. The PMCF Report — summarising findings from PMCF activities — feeds into the PSUR (Class IIb/III annually or bi-annually) or PMSR (Class I/IIa). Any new PMCF findings affecting the benefit-risk conclusion require an immediate CER update — not a scheduled one. A documented review decision is required even in years where no update is warranted.
This page is the PMCF hub. All PMCF-related service pages and therapeutic verticals link here and receive links back. Use this navigation index to find the most relevant resource for your program.
Eclevar's former TUV SUD reviewers will assess your current PMCF architecture, identify gaps relative to Annex XIV Part B and current Notified Body expectations, and design a defensible program — whatever your device class or therapeutic area.
