Metecon plans and supports PMCF under the MDR and PMPF under the IVDR as a continuation of the clinical evaluation or performance evaluation—risk-based, pragmatic, and clearly integrated with PMS, risk management, and CER/PER. The goal is a PMCF/PMPF file that is robust and has an impact on the market—without overengineering.
Risk-based / without overengineeringPMCF under the MDR and PMPF under the IVDR are not isolated processes, but rather a continuation of clinical evaluation and performance evaluation, respectively, for products on the market. Metecon plans PMCF/PMPF on a risk-based approach, derives the research questions from CER/PER and post-market findings, and ensures that the results are fed back into CER/PER, risk management, and decision-making—without overengineering.
Challenge 1 · Formal Rather Than Substantive
Documents exist, but the connection to open clinical questions, remaining uncertainties, and post-market signals is missing.
Metecon Solution: A PMCF/PMPF plan based on specific open issues identified through CER/PER and post-market surveillance (PMS) findings—derived not generically, but specifically for each product.
Challenge 2 · Not Feasible
Plans that look good on paper but fail in practice due to issues with the recruitment pathway, study sites, or existing data flows.
Metecon Solution: A pragmatic choice of methods based on real-world feasibility—surveys, registries, or routine data are preferred over complex studies whenever possible.
Challenge 3 · No Impact
PMCF/PMPF reports are generated but not systematically integrated into downstream regulatory processes.
Metecon Solution: Closed evidence cycle – PMCF/PMPF results are systematically fed back into CER/PER updates, risk management, PSURs, and, where applicable, CAPAs.
PMCF is the structured post-market clinical follow-up of medical devices—a requirement under Article 83 and Annex XIV, Part B of the MDR. The goal is the ongoing confirmation of safety, performance, and the benefit-risk profile under real-world conditions. PMCF updates the clinical evaluation report (CER) and, for classes IIa, IIb, and III, is incorporated into the PSUR.
PMPF is the IVD equivalent of PMCF: ongoing confirmation of the safety, performance, and scientific validity of in-vitro diagnostic medical devices on the market in accordance with IVDR Article 78 and Annex XIII, Part B. PMPF updates the performance evaluation report (PER) and, for classes C and D, is incorporated into the PSUR.
Collect proprietary data in a targeted manner: where appropriate, clinical trials in accordance with ISO 14155, user surveys, patient registries, and real-world data. Suitable for unresolved clinical questions, new indications, high-risk categories, or in case of insufficient evidence.
Evaluate existing sources: literature, adverse event reports and pharmacovigilance data, EUDAMED, and trends from post-market surveillance. Cost-effective and fast—a mandatory component of every PMCF plan, often supplemented by proactive measures.
The scope and methodology of PMCF/PMPF activities depend on the product class, the available evidence, and the risks associated with the product and its users. Metecon uses a risk-based approach to select data sources that are methodologically appropriate and operationally feasible—not necessarily the most resource-intensive ones.
Both follow the same principle (ongoing evaluation of products on the market), but the selection of data sources differs fundamentally:
PMCF for medical devices is based on clinical studies, user experience, and epidemiological data, while PMPF for IVDs is also based on performance studies and, if applicable, proficiency tests.
Complete PMCF plans in accordance with MDCG 2020-7: Section A (manufacturer contact details), Section B (product description and specification), Sections D–G (additional information). For all risk classes.
PMCF reports in accordance with MDCG 2020-8: Analysis of the PMCF activities conducted, evaluation of the results, conclusions for the CER update, PSUR update, and—for class III devices—input for the SSCP.
Design of PMCF studies in accordance with EN ISO 14155:2020 (Clinical investigation of medical devices for human subjects): study design, benefit versus risk, comparators, sample size planning, endpoint definition—pragmatic and tailored to the specific product.
Cost-effective user surveys as an alternative to clinical PMCF studies: Structured surveys of physicians, nurses, and, where applicable, patients—compliant with regulations and suitable for NB, quickly implementable with a well-established clinical foundation.
PMPF plans and reports in accordance with IVDR Annex XIII, Part B: User surveys, interlaboratory tests, registries, literature, and EUDAMED data. For all IVD risk classes, with a particular focus on classes C and D and IVDs for self-testing.
Gap analysis of existing PMCF/PMPF activities against MDR requirements (Articles 83–86, Annex XIV) and IVDR requirements (Articles 78–81, Annex XIII). Use of existing evidence, prioritized action plan, and an MDR/IVDR-compliant PMCF/PMPF plan for existing products.
PMCF is an ongoing process for structured post-market clinical follow-up —from planning appropriate data collection methods to the documented evaluation of market data.
PMCF is used to continuously evaluate post-market clinical experiences. The scope and methodology must be transparent and documented in a product-specific manner.
Sections A and B: Manufacturer and product data
Manufacturer contact information and contact persons, product description, identifiers, UDI, intended purpose, indications, contraindications, target groups. Section B ensures that the PMCF plan is product-specific and not generic —a common point of criticism raised by Notified Bodies.
Section C: Definition of planned PMCF activities, including methodology, procedures, and timeline
Core of the PMCF Plan: All planned PMCF activities must be documented, including objectives, selected methodology, timeline, and responsibilities. Section C describes why the chosen method—e.g., study, survey, registry, or literature review—is suitable for clinical post-marketing follow-up and what justifies the need to conduct the PMCF measures. Creating a new risk management file vs. revising an existing file
Sections D–G: Reference to the technical documentation, comparator products, and regulatory requirements
Section D contains references to relevant information from the CER and risk management. Section E contains information on comparable products, and section G contains information on applicable common specifications, standards, and guidelines. Section G specifies the planned date for the PMCF report.
The PMCF report must be prepared at least once a year for class III and implantable devices and documents the current data and its initial assessment. The conclusions are incorporated into updates to the CER and PSUR. If new or unknown risks are identified during the PMCF, they are directly incorporated into risk management and may trigger the CAPA (corrective and preventive actions) process and the change control process. Metecon provides support in linking PMCF findings to the quality management system.
Clinical PMCF Study in accordance with ISO 14155
Clinical data collection under real-world conditions—depending on product class, risk, and evidence base. Requires ethics committee approval, monitoring, and clinical trial staff.
▶ When: unresolved clinical questions, class III, new technology, rare complications
PMCF Survey
Structured user surveys for the supplementary evaluation of safety, performance, and user experience. More cost-effective than a clinical trial, can be conducted quickly, and is compliant with standards based on a well-documented clinical foundation.
▶ When: well-established clinical evidence, ongoing validation
Registry data and routine data
Analysis of data from hospital registries, national prosthetic registries, or routine databases. No additional study effort required—data are analyzed retrospectively.
▶ When: good data availability in registries, implants, frequently used products
Literature Data and EUDAMED
Systematic review of new scientific literature and data from EUDAMED (European Database on Medical Devices) as a PMCF activity. Particularly suitable as a supplement to other methods.
▶ When: as a supplement, when there is a solid literature base
What MDCG 2021-25 Means for Existing MDD Products: For products that were CE-certified under the MDD (93/42/EEC) and are now being transitioned to MDR compliance, PMCF must be established in accordance with MDR requirements. Existing clinical data and PMCF activities can be evaluated and reused as part of the MDR transition, but must be reviewed for MDR compliance and completeness in accordance with MDCG 2020-7.
Metecon reviews existing PMCF documents (from the MDD era) against the MDR requirements and MDCG 2020-7: Which activities are still valid? Which methods need to be expanded? Which clinical questions remain unanswered? Result: a prioritized gap report with a cost estimate.
Based on the gap analysis, Metecon will develop a comprehensive MDR-compliant PMCF plan in accordance with MDCG 2020-7 for the existing product. In doing so, existing evidence will be leveraged to the fullest extent possible to minimize the workload and make efficient use of the transition period.
Missing or outdated PMCF documents are a common cause of nonconformities during MDR audits. Metecon quickly identifies gaps and develops a prioritized action plan—even under tight deadlines.
PMCF activities may also be required for certain products without a medical purpose as defined in MDR Annex XVI
MDR Annex XVI lists products without a medical purpose that are nevertheless covered by the MDR—including contact lenses without vision correction, fillers for skin grafts, and liposuction devices. For these products, PMCF is expressly required according to MDR Article 61(9), even if no medical benefit needs to be demonstrated. The PMCF plan for Annex XVI products focuses on safety evidence: tissue compatibility, long-term safety, and adverse reactions. Metecon develops PMCF strategies for Annex XVI products.
PMCF results are incorporated into further regulatory processes and post-market surveillance documents.
PMPF according to IVDR Annex XIII, Part B refers to the IVD-specific performance follow-up. PMPF under IVDR supports the ongoing evaluation of the performance, safety, and scientific validity of in-vitro diagnostic medical devices on the market.
PMPF is mandatory for all IVDs under the IVDR. Manufacturers must prepare a PMPF plan and a PMPF report. PMPF updates the performance evaluation report (PER) and is incorporated into the PSUR for class C and D IVDs.
MDCG 2022-2 describes the general principles of clinical evidence and appropriate PMPF activities for IVDs under the IVDR
MDCG 2022-2, “Guidance on general principles of clinical evidence for in vitro diagnostic medical devices,” is the central guideline for PMPF activities. It defines which data sources can be used for PMPF: user surveys, customer feedback, external quality control programs (proficiency testing), literature data, and EUDAMED data.
User surveys are the most common PMPF method for IVDs: general usage aspects (handling, usability, overall satisfaction), general clinical performance data (sensitivity/specificity in field use), and assessment of specific clinical endpoints (e.g., clinical decision support). Metecon develops questionnaires and performs statistical analyses of the results.
Proficiency tests involve multiple laboratories measuring identical (homogeneous) subsets of a sample. They can also be a component of the PMPF. Consistency of results is evidence of analytical accuracy and reproducibility under routine conditions. Metecon evaluates this data to prepare the PMPF report.
Prospective or retrospective studies to confirm analytical and clinical performance under real-world conditions (e.g., in specific patient populations or new clinical settings).
Analysis of published findings and new market information to assess the state of the art and scientific validity. Changes in prevalence, incidence, or pathogen spectrum (e.g., for infectious disease IVDs) must be addressed, as they could affect clinical performance.
MDCG 2022-8 key message for existing IVDD products: The PMPF requirement also applies to legacy IVDs (products with a valid certificate of conformity under the IVDD). However, manufacturers are not required to prepare a PMPF report retroactively. PMPF activities must, however, be initiated, and their results will be incorporated into future PERs. Metecon develops the PMPF plan for legacy IVDs in accordance with regulatory requirements.
PMPF results form the basis for updating the PER (IVDR Annex XIII). For class C and D IVDs, PMPF results are also incorporated into the PSUR (Periodic Safety Update Report). Metecon consistently prepares the PMPF plan, PMPF report, PER, and PSUR from a single source.
Class C (e.g., blood group determination, detection of sexually transmitted pathogens or infectious agents, prenatal screening tests) and class D (e.g., hepatitis tests, HIV tests) are subject to particularly stringent PMPF requirements: PMPF results are incorporated annually into PSURs and PERs. For class D devices, the updated PSURs are reviewed by Notified Bodies. Metecon develops a PMPF strategy for class C and D IVDs with clear guidelines on objectives, methodology, and criteria.
Both point-of-care IVDs and devices for self-testing require specific PMPF activities: the focus is particularly on usability and the interpretation of results. Metecon designs user surveys and performs statistical analyses of the data.
Dr. Grit Kasper leads the Clinical Affairs team for medical devices at Metecon. Key areas of focus in PMCF: risk-based PMCF plans (MDCG 2020-7) and PMCF reports (MDCG 2020-8) for medical devices of all classes under the MDR. Grit and her team integrate planning, data collection, analysis, and conclusions in a way that ensures results can be consistently fed back into clinical evaluation, post-market surveillance (PMS), and risk management—using a pragmatic approach rather than overengineering. Additional areas of expertise: PMCF surveys and related documents such as CERs and SSCPs.
"Effective PMCF generates robust clinical evidence throughout the entire product life cycle. It is therefore not merely a formal activity of the clinical or regulatory department, but rather combines regulatory compliance with genuine added value for marketing, product management, and R&D."
– Dr. Grit Kasper, Team Lead Clinical Affairs (Medical Devices), Metecon
Dr. Sandra Reuter leads the IVD team at Metecon and supports manufacturers in planning and implementing PMPF activities in accordance with the IVDR. Her team analyzes post-market data and ensures that PMPF results are consistently incorporated into performance evaluation and risk management: Linking these areas is not a given, but rather the result of structured processes.
“PMPF provides evidence of how an IVD’s performance and safety are validated in the market and where new areas for action arise. It is crucial that the results are systematically incorporated into performance evaluation, risk management, and other post-market activities.”
– Dr. Sandra Reuter, Team Lead IVD, Metecon
The choice depends on the product, the available data, and the risk class. PMCF surveys
(user or patient surveys) are often sufficient for established products with a good safety profile and sufficient literature. Clinical PMCF studies become necessary when the clinical assessment reveals data gaps—for example, in the case of new indications, high-risk products, or findings from PMS and pharmacovigilance that require systematic data collection. Metecon derives the decision from the clinical evaluation and risk management file—in a risk-based manner and without overengineering.
PMCF/PMPF is not an isolated process, but rather the continuation of the post-market clinical/performance evaluation—with direct feedback into CER/PER and the risk management file. The requirements arising from clinical/performance evaluation, and risk management determine the PMCF/PMPF strategy; the results are fed back into these evaluations. Metecon establishes the processes in such a way that a verifiable data cycle is created.
The PMCF plan describes objectives, methods, data sources, a timeline, and responsibilities. MDCG 2020-7 structures this using mandatory fields: from justifying the methodology to linking it to clinical evaluation, the PMS plan, and risk management. A good PMCF plan is specific enough for a Notified Body to understand the data strategy and streamlined enough for the team to implement it effectively. Metecon creates MDR-compliant plans in accordance with MDCG 2020-7—pragmatic and auditable.
The spectrum ranges from structured user surveys and patient registries to real-world data analyses and post-market clinical studies. The choice is risk-based: the greater the data gap, class risk, and PMS findings, the more robust the method must be. Metecon selects the method that is both regulatory-compliant and operationally feasible—without overengineering.
PMCF results are the driving force behind all post-market clinical documents: The CER is updated with every PMCF report. The PSUR (periodic safety update report) for class IIb/III includes PMCF conclusions. The SSCP (summary of safety and clinical performance) for class III must reflect PMCF findings. Metecon prepares all four documents and ensures consistency in their content.
PMPF (post-market performance follow-up) evaluates the performance of IVDs on the market—using IVDR-specific requirements for analytical and clinical performance, data sources (laboratory data, performance studies, real-world evidence), and the integration of these findings into the performance evaluation (PER). The MDR, on the other hand, focuses on the clinical safety and performance of medical devices in patients. Metecon plans PMPF/PMCF on a product-specific basis, even if a manufacturer operates in both areas.
According to the MDR/IVDR, legacy devices require a PMCF/PMPF strategy—even if, historically, there is very little systematic clinical data available. The pragmatic approach involves a structured assessment (What do we already have? Where are the gaps?), risk-based data collection, and step-by-step consolidation. Metecon supports the transition for legacy devices—pragmatically and efficiently.
The cost depends on the product, the available data, the methodology, and the target audience. Following a free initial consultation with Dr. Caroline Arnold, Metecon will provide a transparent, fixed-price quote.
PMCF/PMPF is not a standalone process, but is embedded in a closed evidence cycle. These interfaces ensure that outcomes have an impact.
Start with a free initial consultation and get a clear assessment—PMCF plan, choice of methods, legacy gap analysis, or PMPF concept.
Your contact:
Dr. Caroline Arnold
Head of Sales
T: +49 621 123469-037
caroline.arnold@metecon.de
