Metecon Service
We develop the right PMCF strategy for your product and guide you through the process from planning to implementation—ensuring regulatory compliance while minimizing the workload for your team.
Medical Devices (MDR) In-Vitro Diagnostic Medical Devices (IVDR)
Clinical Evaluation / CER Under the MDR & Performance Evaluation / PER Under the IVDR
Metecon prepares the clinical evaluation or performance evaluation not only for review by the Notified Body, but also as a guiding document for the entire product life cycle—with a clear, robust line of reasoning. We pragmatically prioritize gaps in the evidence and ensure seamless integration with risk management, technical documentation, and PMS. The goal is clinical substance combined with operational feasibility.
20+ years in Clinical Affairs · 150+ CEP & CER · 200+ State of the Art (SotA) Reviews20+
Years of Clinical Affairs Experience
150+
CEP & CER created
200+
State-of-the-Art Research & Literature Reviews
20+
Clinical/RA Experts
Overview
Medical Devices
In-vitro Diagnostics
Clinical Evaluation vs. Performance Evaluation: Clinical Evidence Under the MDR and IVDR
Manufacturers of medical devices and in-vitro diagnostic medical devices (IVDs) must demonstrate that their products are safe, effective, and suitable for their intended purpose. For medical devices, this is demonstrated through clinical evaluation, including a clinical evaluation report (CER); for IVDs, through performance evaluation, including a performance evaluation report (PER). Both documents are mandatory components of the technical documentation under the MDR and IVDR—and at the same time, they are far more than just required regulatory documents: They form the evidence base for safe products, robust regulatory decisions, and sustainable market access.
A robust strategy for clinical evidence does not begin just before marketing authorization. Decisions that directly influence the subsequent clinical evaluation or performance evaluation are made as early as the development phase, during risk management, and while developing the market strategy. Early integration—for example, with risk management, PMS, PMCF/PMPF, product development, biological safety, usability engineering, and quality management—helps identify data gaps in a timely manner and avoid delays in the approval process or with the Notified Body.
Metecon prepares the clinical assessment not only for review by the Notified Body but also as a guiding document for the entire product life cycle. We consolidate, analyze, and evaluate all available (pre)clinical data in comparison with the state of the art (SotA), pragmatically prioritize gaps in evidence, and ensure seamless integration with risk management, technical documentation, and PMS. The goal is to achieve clinical substance combined with operational feasibility—robust enough for evaluation and maintenance throughout the product life cycle.
CER vs. PER: Comparison of the MDR and the IVDR
| Criterion | Clinical Evaluation & CER (MDR) | Performance Evaluation & PER (IVDR) |
| Regulation | MDR (EU) 2017/745 | IVDR (EU) 2017/746 |
| Document | clinical evaluation report (CER) | performance evaluation report (PER) |
| Legal Basis | MDR Art. 61, Annex XIV | IVDR Art. 56, Annex XIII |
| Objective | demonstration of safety and performance, clinical benefit, and a favorable benefit-risk ratio throughout the entire product life cycle | demonstration of safety, performance, scientific validity, analytical and clinical performance, and a positive benefit-risk ratio throughout the entire product life cycle |
| Data sources | Cclinical data, PMS/PMCF data, literature, clinical trials, state of the art (SotA), risk management | scientific validity, analytical performance, clinical performance, PMS/PMPF data, literature, performance studies, state of the art (SotA), risk management |
| Strategic Interfaces | risk management, PMS, PMCF, product development, usability engineering, biological safety | risk management, PMS, PMPF, product development, usability engineering |
| Guidelines | MDCG 2020-1, MDCG 2020-5, MDCG 2020-6, MDCG 2020-7, MDCG 2020-8, MDCG 2020-9 | MDCG 2020-1, MDCG 2022-2 |
| Post-Market | PMCF as part of continuous clinical evaluation | PMPF as part of ongoing performance evaluation |
| Updates | continuously throughout the product life cycle, depending on risk class, PMS/PMCF findings, and regulatory requirements | continuously throughout the product life cycle, depending on risk class, PMS/PMPF findings, and regulatory requirements |
| Metecon Added Value | strategic planning of clinical evaluation, PMCF integration, evidence strategy, literature review, templates, regulatory validation, and holistic assessment | strategic planning of performance evaluation, PMPF integration, evidence strategy, literature review, templates, regulatory validation, and holistic assessment |
3 Common Challenges in Clinical Evaluation / Performance Evaluation—and How Metecon Solves Them
Challenge 1
Product claim cannot be substantiated
The intended purpose (product promise) cannot be convincingly substantiated with the available data.
Metecon Solution: We systematically cross-check product claims against the available evidence—and identify gaps in the data early on.
Challenge 2
Evidence is not systematically linked
Existing evidence is not systematically evaluated and linked to the state of the art—clinical reasoning remains incomplete and open to criticism.
Metecon Solution: A documented literature review process and a transparent evidence assessment as a robust line of reasoning.
Challenge 3
Documents tell different stories
Clinical evaluation/performance evaluation, risk management, and technical documentation tell different stories and lead to follow-up questions.
Metecon Solution: Consistent messages so that the CER/PER, risk file, and TechDoc all support the same line of reasoning.
Clinical Evaluation & Performance Assessment: All Clinical Affairs Services at a Glance
We support manufacturers of medical devices and in-vitro diagnostic medical devices with clinical and performance-related evidence throughout the entire product life cycle.
Create CERs & PERs
Strategic planning, preparation, and updating of clinical evaluations (CER) in accordance with the MDR and performance evaluations (PER) in accordance with the IVDR—regulatorily sound, evidence-based, and tailored to the product, risk class, and overall regulatory strategy. From the early development phase through long-term maintenance across the entire product life cycle.
Literature Review & Evidence Assessment
Systematic literature reviews in accordance with MDR, IVDR, and MEDDEV 2.7/1 requirements, including an assessment of clinical evidence, state of the art (SotA), data quality, and regulatory validity—as a robust foundation for CER, PER, and clinical and performance-based strategies.
Templates & Processes
Development of standardized templates and efficient clinical affairs processes for CER, PER, PMCF, and PMPF—to ensure consistent documentation, structured updates, and robust, sustainable regulatory processes, as well as integration into existing workflows, quality management processes, and digitalization strategies.
Training & Consulting
Practical training and strategic consulting on clinical evaluation, performance evaluation, CER, PER, PMCF, and PMPF—tailored to products, processes, and regulatory challenges. For regulatory affairs, clinical affairs, quality management, and interdisciplinary project teams.
Clinical Evaluation Under the MDR: CER Preparation & PMCF
Through the clinical evaluation, you, as the manufacturer, demonstrate compliance with the general safety and performance requirements for your medical device. You provide evidence that the product delivers the medical benefits promised in its intended purpose and the product information—the clinical effect and safety over the expected service life are the subject of the assessment.
The clinical evaluation is based on clinical data from the scientific literature and/or the manufacturer’s own clinical trials. It is part of the technical documentation and must be conducted in accordance with Article 61 of the MDR, regardless of the risk class.
Principle of Equivalence Under the MDR: When Is a Literature Review Sufficient?
Under the MDR, clinical data from similar (equivalent) products may only be used under certain conditions. The product must be demonstrated to be equivalent from a technical, biological, and clinical standpoint. The manufacturer must have contractually guaranteed access to the technical documentation of the equivalent product (MDR Art. 61(5)). We will assess which evidence pathway is optimal for you.
CER Preparation:
Our Scope of Services for MDR
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planning and conducting a scientific, documented literature review
in accordance with MEDDEV 2.7/1 Rev. 4 -
evaluation and analysis of current clinical data and literature
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analysis of PMS data and findings from market surveillance
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evaluation of clinical trial results in accordance with MDR Annex XV
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equivalence analysis: technical, biological, and clinical in accordance with MDR Article 61 (5) and MDCG 2020-5
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preparation of the clinical evaluation plan (CEP) and the clinical evaluation report (CER)
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classification with regard to the state of the art
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templates for CEP, CER, PMCFP, and PMCFR for independent maintenance
PMCF: Post-Market Clinical Follow-up According to the MDR – Process and Activities
Clinical evaluation is an ongoing process. The MDR requires regular updates to the relevant documents throughout the entire product life cycle—supported by structured PMCF (post-market clinical follow-up) activities. PMCF complements the initial clinical evaluation: While clinical evidence is initially provided at the time of approval, PMCF ensures the continuous confirmation of safety and performance after the product is placed on the market.
PMCF Activities: Which Methods Are Available?
The MDR permits various PMCF activities. The choice depends on the risk class, product type, and available data:
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Systematic Literature Review: continuation of the initial CER literature review in accordance with MEDDEV 2.7/1 Rev. 4—a mandatory component of every PMCF plan
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User Surveys: structured surveys of patients and healthcare professionals regarding product safety and performance in clinical practice
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Long-term Observations: registry studies or long-term cohort studies for products with a relevant long-term safety profile
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Post-Market Clinical Follow-up Studies (PMCF Studies): market surveillance studies for CE-marked products within their intended purpose—in accordance with ISO 14155
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Analysis of PMS data: complaints, vigilance reports, customer feedback
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Database searches: EUDAMED, MAUDE (FDA), BfArM database on similar products
PMCF Studies Under the MDR: Post-Market Clinical Data
Clinical data must be proactively collected and evaluated after the device has been placed on the market to determine whether the original clinical evaluation needs to be updated. The PMCF methods used for this purpose include conducting post-market surveillance studies with the CE-marked medical device. EN ISO 14155 specifies the requirements for the design, conduct, and reporting of clinical trials and must be applied to these studies.
Metecon supports you in planning, drafting the clinical investigation plan (CIP), preparing reports, applying for ethics committee approval, and submissions to regulatory authorities.
SSCP and PSUR: Additional Reporting Requirements Under the MDR
For devices in class IIa and above, additional reports must be submitted regularly in addition to the PMCF report:
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PSUR (Periodic Safety Update Report) – Class IIa and Above: Regular safety report including a benefit-risk assessment, PMCF findings, and sales data. The update interval depends on the risk class (MDR Art. 86).
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SSCP (Summary of Safety and Clinical Performance) – Class III and Implants: A publicly accessible mandatory document that summarizes the clinical evaluation. It is validated by the Notified Body and published in EUDAMED (MDR Art. 32). The SSCP must be updated at least once a year.
Metecon supports you in preparing both documents—integrated into your PMCF strategy and CER update cycles.
Metecon Service
We can assist you in preparing both documents—integrated into your PMCF strategy and CER update cycles.
PMCF: Metecon's Scope of Services
- development of a PMCF strategy: identification of appropriate activities for your product and risk class
- PMCF plan according to MDCG 2020-7: objectives, methods, responsibilities, timeline
- PMCF report in accordance with MDCG 2020-8: evaluation of PMCF data, update of the CER
- PMCF study planning: preparation of the CIP in accordance with ISO 14155
- systematic literature review in the PMCF cycle according to MEDDEV 2.7/1 Rev. 4
- PSUR preparation for class IIa and above (regular update cycles)
- SSCP preparation for class III Devices and implants
- templates for your team to independently maintain PMCF documentation
Applicable Standards & Guidelines: Clinical Evaluation According to the MDR
- MDR (EU) 2017/745 – Article 61, Annex XIV (clinical evaluation)
- MEDDEV 2.7/1 Rev. 4 – Clinical Evaluation (guidance on clinical evaluation)
- MMDCG 2020-5 – Guidance on Clinical Evaluation & Equivalence
- MMDCG 2020-6 – Sufficient Clinical Evidence for Legacy Devices
- MDCG 2020-7 – Guidance on the PMCF plan template
- MDCG 2020-8 – Guidance on the PMCF evaluation report template
- ISO 14155 – Clinical investigation of medical devices for human subjects – good clinical practice
Product Life Cycle Reporting: Plans and Reports Working Together
The MDR defines a series of interrelated plans and reports spanning the entire product life cycle. Some follow fixed intervals, while others must be integrated into the cycle in a meaningful way.
The collection of clinical data must be planned as early as the development phase —after the CE marking, the manufacturer enters a continuous process of reporting and plan adjustments. The interdependencies between the documents are crucial:
To ensure that all requirements are met on time, every step must be carefully coordinated. Metecon provides support for both the strategic planning and the effective implementation of this reporting cycle.
Following a free initial consultation, you’ll receive a transparent quote from Metecon with a well-founded estimate of the work involved. Billing is based on actual time spent, so you retain full control over your budget at all times. Contact us for a no-obligation assessment.
CEP → CER
The clinical evaluation plan (CEP) defines the methods and data to be used to demonstrate clinical safety, performance, and clinical benefit; the clinical evaluation report (CER) presents the results and is continuously updated with PMCF data to demonstrate ongoing compliance with the general safety and performance requirements (GSPR).
PMS Plan & PMCF Plan
The PMS plan defines the nature and scope of post-market surveillance; the PMCF plan describes the proactive collection of clinical data following the medical device’s market release. Both take into account the findings from the CER and are updated as new aspects or findings arise.
PMCF Report → CER Update
The PMCF report summarizes the data from the post-marketing clinical performance monitoring. Relevant findings are incorporated into the clinical assessment, so the CER must be updated accordingly. The PMCF report must also include a conclusion as to whether regulatory or technical follow-up actions are necessary.
PMS Report / PSUR & SSCP
A PMS report is prepared for class I devices; for class IIa, IIb, and III devices, a PSUR is prepared, including a benefit-risk conclusion and PMCF findings. For class III devices and implants, the SSCP—which is updated annually and publicly available via EUDAMED—is also required.
Performance Evaluation Under the IVDR: PER, Performance Studies, and PMPF
As a manufacturer of an in-vitro diagnostic medical device (IVD), you must evaluate all relevant data on scientific validity, analytical performance, and clinical performance to verify that your product complies with the essential safety and performance requirements set forth in Annex I of the IVDR.
The performance evaluation report (PER) summarizes the clinical evidence for your IVD and is a prerequisite for the conformity assessment under the IVDR. The PER must be updated as needed for classes A and B, and at least annually for classes C and D (IVDR, Art. 56).
The Three Pillars of Performance Evaluation Under the IVDR
1
Scientific Validity
demonstration of the relationship between the analyte and a specific clinical or physiological condition
2
Analytical Performance
demonstration of the IVD’s ability to correctly detect or measure a specific analyte
3
Clinical Performance
demonstration that the IVD can provide results that correlate with a clinical condition or a physiological or pathological process or condition in a specific target population and among specific intended users
PER Development: Our Scope of Services for IVDs
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development and evaluation of the performance evaluation plan (PEP)
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providing evidence that the scientific validity, analytical performance, and clinical performance of the product are sufficiently demonstrated for its intended purpsoe.
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evaluation of analytical performance data: sensitivity, specificity, accuracy, limit of detection, precision, interferences, cross-reactions
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preparation of the performance evaluation report (PER) in accordance with IVDR Annex XIII
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consulting on performance studies and their regulatory requirements (IVDR Annex XIII, Part B)
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common specifications (CS) for class D IVDs – review and application
Applicable Standards & Guidelines: Performance Evaluation According to the IVDR
- IVDR (EU) 2017/746 – Article 56, Annex XIII (performance evaluation + PMPF)
- IVDR Annex I – general safety and performance requirements
- MDCG 2022-2 – Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs)
- MDCG 2022-2 – Guidance on IVDR Performance Evaluation
- cCommon specifications (CS) for class D IVDs
- ISO 20916 – Clinical performance studies using specimen from human subjects – Good study practice
- CLSI Standards – methods for analytical performance evaluation
- GHTF/SG5/N6:2012 – Clinical Evidence for IVD: Key Definitions
- GHTF/SG5/N7:2012 – Scientific Validity & Performance Evaluation
Clinical Performance Studies Under the IVDR: When, Why, and How?
Evidence of an IVD’s clinical performance can be based on various sources: peer-reviewed literature, published routine diagnostic data, or the manufacturer’s own clinical performance studies in accordance with IVDR Annex XIII, Part B. In-house performance studies are always required when no other sufficient clinical performance data are available.
Do I Need a Performance Study? The Decision-Making Framework
The need for a dedicated clinical performance study depends on three factors. Metecon can help you by conducting a gap analysis of your existing clinical data—so you can determine early on whether any studies are required for your product, and if so, which ones.
Risk Class
The higher the risk class (A → D), the more stringent the requirements regarding the scope and robustness of the clinical evidence. For products in higher risk classes, it may be necessary to generate additional data through clinical performance studies if the existing evidence is insufficient for the intended purpose.
Degree of Standardization of the Test
For established and standardized tests, existing literature and routine data may be sufficient. For new biomarkers, companion diagnostics, or innovative technologies, additional performance studies are usually necessary.
Availability of Legacy Data
Clinical data from the IVDD era may continue to be used under certain conditions. However, this data is often insufficient to fully meet the requirements of the IVDR.
Clinical Performance Studies According to ISO 20916: Planning and Conduct
Clinical performance studies for IVDs are conducted based on a clinical performance study plan (CPSP). ISO 20916 defines good study practice for the planning, design, conduct, documentation, and reporting of these studies.
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Preparation of the Clinical Performance Study Plan (CPSP) in accordance with ISO 20916
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Statistical Study Planning: sample size calculation, definition of clinical endpoints and performance parameters (sensitivity/specificity)
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Coordination with study sites, laboratories, and sample suppliers (e.g., sera, plasma, human samples)
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Support with ethics committee procedures and communication with regulatory authorities
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Oversight of Study Conduct and quality assurance of collected data
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Clinical Performance Study Report: analysis of the data and preparation of the report, as well as integration of the study data into PER, PMS, and technical documentation
PMPF: Post-Market Performance Follow-up Under the IVDR – Process and Activities
IVDR Annex XIII, Part B governs post-market performance follow-up (PMPF)—the IVD equivalent of the PMCF process under the MDR. PMPF is a continuous process designed to monitor the performance of an IVD throughout its entire life cycle under real-world conditions and in the current scientific context (state of the art). The performance evaluation report (PER) is continuously updated using the collected data. As a manufacturer, you are required to develop a PMPF plan and submit regular PMPF reports —as part of your PMS system.
PMPF combines pre-market clinical evidence with findings from post-market surveillance and is an integral part of the PMS process. PMPF complements performance evaluation; it does not replace it.
PMPF Activities: Methods for Post-Market Performance Monitoring
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Proficiency Testing (External Quality Assurance): participation in proficiency testing as an efficient method for validating analytical performance in comparison with other laboratories
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Systematic Literature Review: continuous monitoring of the state of the art in science and technology and new clinical evidence regarding your analyte
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User Surveys: surveys of laboratory staff and healthcare professionals regarding the product’s performance in routine diagnostics
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Evaluation of Routine Diagnostic Data: internal data from ongoing laboratory use, provided it is regulatory-compliant and reliable, as the evidence base for the PMPF assessment
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Long-term Monitoring: continuous monitoring of diagnostic performance over the product life cycle
- PMPF Studies: performance studies for CE-marked IVDs in accordance with ISO 20916, if other PMPF activities are insufficient
PMPF & Performance Studies: Scope of Services at Metecon
- development of PMPF strategies based on risk class and product type
- preparation of a PMPF plan in accordance with IVDR Annex XIII, Part B: methods, timeline, responsibilities
- preparation of a PMPF report to evaluate the collected data and update the PER
- conducting gap analyses of clinical performance data: Is an additional performance study required?
- planning of performance studies: CPSP in accordance with ISO 20916
- coordination of study sites and laboratories: sample management, communication with ethics committees and competent authorities
- updating the PER with PMPF results—regulatorily sound for Notified Bodies
Dr. Grit Kasper
Team Lead Clinical Affairs (Medical Devices) · Metecon GmbHDr. Grit Kasper leads the Clinical Affairs team for medical devices at Metecon. Her team collates, analyzes, and evaluates all available (pre)clinical data against the state of the art, derives the benefit-risk ratio, and pragmatically prioritizes gaps in evidence—with clear interfaces to risk management, technical documentation, and PMS. Key areas of focus: clinical assessments in accordance with the MDR and MEDDEV 2.7/1 Rev. 4, PMCF, and SSCPs. The team coordinates with external medical experts to ensure the technical validity of the assessment.
"We prepare the clinical evaluation not only for review by the Notified Body, but also as a guiding document throughout the entire product life cycle. The goal is to provide robust clinical evidence that is operationally feasible, enabling efficient interaction with the Notified Body as well as sound regulatory and strategic decisions."
– Dr. Grit Kasper, Team Lead Clinical Affairs (Medical Devices), Metecon
Dr. Sandra Reuter
Team Lead IVD · Metecon GmbHDr. Sandra Reuter leads the IVD team at Metecon, which provides all clinical affairs services for IVDs from a single source. A biologist with a Ph.D., she has more than 20 years of experience in the development and regulatory evaluation of IVDs. Together with her team, she develops strategies for performance evaluation and integrates scientific validity, analytical performance, and clinical performance into a consistent assessment in accordance with the IVDR. In doing so, she systematically assesses the state of the art, existing evidence, and potential data gaps. Clear interfaces with risk management, PMS, and PMPF ensure that performance evaluation can be continued throughout the entire product life cycle.
"A performance evaluation combines scientific validity, analytical performance, and clinical performance into a consistent evidence base that is continuously refined in line with the product and the state of the art."
– Dr. Sandra Reuter, Team Lead IVD, Metecon
Frequently Asked Questions About Clinical Evaluation and Performance Evaluation
Answers to the most important questions about CER, PER, MDR, and IVDR.When is the right time to begin the clinical evaluation/performance evaluation—and when does starting later become a structural problem?
The clinical evidence strategy should begin during the product’s design and development phases, not just shortly before registration. Decisions related to development, risk management, usability engineering, and biological safety directly influence the subsequent clinical/performance evaluation. Those who start too late only discover data gaps when rework is costly and timelines are tight. An early, structured approach identifies gaps in the evidence while they are still manageable. Metecon therefore gets involved in the early development phase and provides ongoing support for changes and PMS updates.
How does Metecon ensure that the clinical/performance evaluation remains consistent in the event of product changes or new PMS findings, and does not have to be rebuilt from scratch each time?
From the outset, the planning for the clinical/performance evaluation is structured to create a maintainable master document that can be used throughout the entire product life cycle—with a clear line of reasoning and well-defined interfaces to risk management, technical documentation, and PMS. Product changes and new PMS/PMCF findings are incorporated in a targeted manner, rather than rebuilding the document from scratch each time. This ensures that the planning rationale remains consistent and the maintenance effort remains predictable.
How can a manufacturer determine whether its existing clinical/performance evaluation will stand up to the next evaluation?
Three indicators: (1) Every product promise and claim is supported by robust clinical evidence in line with the state of the art (SotA). (2) The available evidence has been systematically evaluated, and the literature review process has been transparently documented. (3) Clinical/performance evaluation, risk management, and technical documentation all tell the same story. If any of these points lack robustness, the Notified Body will typically raise questions during the evaluation. Metecon verifies this robustness as part of a gap analysis.
How are verification and validation evidence related to clinical/performance evaluation evaluation, and where do inconsistencies typically arise?
V&V evidence demonstrates that the product meets the specified requirements; the clinical evaluation/performance evaluation places this evidence in the context of safety, performance, and benefit-risk. Inconsistencies typically arise when design changes or corrective actions are not properly documented and evaluated, or when the intended purpose, claims, and V&V results do not fully align. Metecon ensures that V&V results and the clinical/performance evaluation are consistent with one another.
What role does the medical expert play in preparing the clinical evaluation?
The medical expert provides the medical-technical perspective: He or she assesses the clinical relevance of the data, interprets the evidence and the state of the art from a medical standpoint, and lends professional authority to the clinical evaluation. According to the MDR, the clinical evaluation must be prepared or reviewed by appropriately qualified individuals. Metecon coordinates and strategically engages external medical experts to ensure the technical validity of the evaluation.
To which extent do marketing claims play a role in clinical evaluation / performance evaluation?
Any claim regarding safety, performance, or clinical benefit is considered part of the intended purpose and must therefore be supported by evidence—this is a key requirement of the MDR/IVDR. Marketing claims that go beyond the proven performance and safety are a common reason for inquiries from the Notified Body. Metecon systematically compares claims and statements with the available evidence and identifies early on where a claim cannot be substantiated or requires additional data.
Which role does clinical evaluation/performance evaluation play in relation to PMCF/PMPF—and when is an additional clinical trial/performance study actually necessary?
Clinical evaluation/performance evaluation demonstrates the safety and performance of a medical device or IVD. PMCF/PMPF specifically collects data to confirm this safety and performance after the product has been placed on the market. Not every gap in evidence automatically leads to a clinical trial or performance study: The need to conduct such studies arises when sufficient data are not available or when the existing data are not transferable to the specific product. Metecon pragmatically reviews the available data, assists in determining whether additional studies are necessary, and thus avoids unnecessary effort that adds no value.
How much does a clinical evaluation by Metecon cost?
The effort involved depends on several factors: risk class and product complexity, the available data and the maturity of the existing evidence, the scope of the required literature review and equivalence assessment, the number of product variants, and the desired level of support. A pragmatic prioritization of evidence gaps reduces overall costs. Following a free initial consultation, Metecon provides a transparent quote with a well-founded estimate of the effort required. Billing is based on actual time spent, ensuring that clients retain full control over their budget at all times.
Related Services:
PMCF, PMPF, and Clinical Trials under the MDR
Clinical Evaluation / Performance Evaluation: Start the process for clinical evidence now
The more context you provide, the more accurately we can assess your request and recommend an efficient evidence-gathering process. The initial consultation is free of charge.
No-obligation initial consultation: 30 minutes free of charge • Response within 2 business days • Confidentiality guaranteed
Your contact:
Dr. Caroline Arnold
Head of Sales
T: +49 621 123469-037
caroline.arnold@metecon.de
