Clinical Affairs & Clinical Evaluation
Rigorous clinical evaluation, literature appraisal, PMCF planning, and clinical investigation support — delivering the clinical evidence foundation your medical device needs for EU MDR compliance and sustained market access.
Overview
Clinical evidence is the single most scrutinized element of medical device regulatory submissions under EU MDR 2017/745. The regulation fundamentally elevated the role of clinical evaluation, requiring manufacturers to demonstrate that their devices achieve their intended clinical benefits, that known risks are acceptable relative to those benefits, and that claims made about the device are supported by adequate clinical data. This evidence must be continuously updated throughout the device lifecycle through active post-market clinical follow-up (PMCF). For many manufacturers, the clinical evaluation requirements under MDR represent the most significant compliance challenge in the transition from MDD — and the area most likely to generate notified body findings and delays.
Swiss MPC provides end-to-end clinical affairs support, from initial clinical development strategy through CER authorship, PMCF study design, and ongoing clinical data management. Our clinical evaluation specialists have authored CERs for devices across all risk classes, including Class III implantable devices, active implantable devices, Class IIb drug-device combinations, and high-risk IVDs. We bring deep familiarity with the MEDDEV 2.7/1 Rev 4 methodology, the MDCG 2020-5 and 2020-6 guidance documents on clinical evaluation, and the evolving expectations of notified bodies who are applying increasingly rigorous standards to clinical evidence assessment.
Our literature review and appraisal process follows a systematic, reproducible methodology that satisfies both MEDDEV 2.7/1 Rev 4 requirements and the scientific rigor expected by notified body clinical reviewers. We develop comprehensive search protocols, conduct searches across PubMed/MEDLINE, Embase, Cochrane Library, and other relevant databases, apply predefined selection criteria, appraise the methodological quality of each identified study, and synthesize findings into structured analyses that directly address your device's safety and performance claims. For devices relying on equivalence to an existing device, we prepare detailed equivalence demonstrations addressing the technical, biological, and clinical characteristics required under MDR Article 61(5).
Beyond CER authorship, we support manufacturers with the full spectrum of clinical affairs activities: designing and managing PMCF studies in compliance with MDCG 2020-7 and 2020-8, developing clinical development plans that align regulatory strategy with clinical evidence generation, planning and conducting clinical investigations under ISO 14155, preparing clinical investigation submissions to competent authorities and ethics committees, and integrating clinical data from post-market surveillance, complaint handling, and vigilance reporting into the ongoing clinical evaluation process. Our goal is to build a sustainable clinical evidence strategy that supports not only initial market access but long-term device lifecycle management.
Clinical Affairs Challenges in the MDR Era
Equivalence Demonstration Under MDR
EU MDR Article 61(5) imposes substantially stricter requirements for claiming equivalence to an existing device compared to the MDD. Manufacturers must demonstrate equivalence across technical, biological, and clinical characteristics, and — critically — must have sufficient access to the equivalent device's technical documentation to justify the comparison. For manufacturers relying on competitor devices as equivalents, this access requirement is often insurmountable, forcing a shift toward generating proprietary clinical data through PMCF studies or clinical investigations.
Insufficient Clinical Data for Legacy Devices
Many devices that have been on the market for years or even decades under MDD certificates were originally placed with limited clinical evidence by today's standards. Under MDR, these devices must now demonstrate the same level of clinical evidence as newly developed products. Manufacturers face the challenge of retrospectively building a clinical evidence base — through literature reviews, registry data analysis, PMCF surveys, and sometimes prospective clinical studies — for well-established devices that may have never undergone formal clinical investigation.
PMCF Study Design and Execution
PMCF is no longer a passive activity under MDR — it requires a proactive, planned, and scientifically sound approach to collecting and analyzing clinical data from devices in routine clinical use. Manufacturers must design PMCF activities that generate statistically meaningful data to confirm ongoing safety and performance, detect emerging risks, and identify previously unknown side effects. Designing studies that are methodologically robust, clinically feasible, and proportionate to device risk while managing investigator engagement and data quality presents significant operational challenges.
Notified Body Clinical Scrutiny
Notified bodies have substantially increased their clinical evaluation capabilities and expectations under MDR. Many have hired dedicated clinical assessors — including physicians and clinical research professionals — who review CERs with a level of scientific scrutiny that far exceeds historical practice under MDD. Inadequate clinical evidence is now the most common reason for notified body delays and certificate refusals, making the quality and completeness of clinical evaluation documentation more critical than ever.
State of the Art Determination
Under MDR, the clinical evaluation must demonstrate that the device achieves a benefit-risk profile that is consistent with a high level of protection of health and safety, taking into account the current state of the art. Defining the clinical state of the art for a specific device type requires comprehensive analysis of current treatment alternatives, published clinical outcomes, guidelines, and accepted clinical practice — an analysis that must be updated throughout the device lifecycle as medical practice evolves.
Our Clinical Evaluation Approach
Clinical Evidence Strategy Development
We begin by assessing your device's clinical evidence landscape — existing clinical data, available literature, claims to be supported, and equivalence possibilities — to develop a comprehensive clinical evidence strategy. This strategy defines the optimal path to demonstrating clinical safety and performance, identifies evidence gaps, and outlines the most efficient approach to addressing them, whether through literature-based evaluation, equivalence argumentation, PMCF activities, or prospective clinical investigation.
Systematic Literature Review
Our literature review process follows a rigorous, documented protocol aligned with MEDDEV 2.7/1 Rev 4 Stage 1-3 methodology. We develop search strategies tailored to your device type and intended purpose, conduct comprehensive searches across medical and engineering databases, apply predefined inclusion/exclusion criteria, perform critical appraisal of identified studies using established quality assessment tools, and compile structured data extraction tables. The resulting literature analysis directly feeds the clinical evaluation and provides the evidentiary foundation for safety and performance claims.
Clinical Evaluation Report Authorship
Our CER authors — qualified per MEDDEV 2.7/1 Rev 4 requirements with relevant clinical and scientific expertise — compile the complete clinical evaluation report. The CER integrates all available clinical evidence: literature data, pre-clinical testing results, clinical investigation data (where available), equivalence analysis, post-market surveillance data, and PMCF results. The report includes a structured benefit-risk analysis, evaluation of each clinical claim, and clear conclusions on the device's clinical safety and performance that are traceable to the underlying evidence.
Equivalence Assessment
Where an equivalence-based clinical evaluation pathway is appropriate and defensible, we develop detailed equivalence demonstration documents that systematically compare the subject device with the proposed equivalent device across all three domains required by MDR Article 61(5): technical characteristics (design, specifications, materials, surfaces), biological characteristics (biocompatibility, tissue contact), and clinical characteristics (intended purpose, clinical conditions, patient populations, clinical outcomes). Each comparison is supported by objective evidence and accompanied by a critical analysis of any identified differences.
PMCF Planning and Study Design
We develop PMCF plans in accordance with MDCG 2020-7 guidance, defining specific objectives, methods, timelines, and statistical rationale for each PMCF activity. For devices requiring PMCF studies — whether surveys, registries, or focused clinical follow-up — we design study protocols, develop case report forms, prepare statistical analysis plans, and support ethics committee and competent authority submissions as required. We ensure PMCF activities are proportionate to device risk and designed to generate actionable clinical data.
Ongoing Clinical Data Management
Clinical evaluation is a continuous process under MDR, not a one-time exercise. We establish clinical data management procedures that systematically collect, analyze, and integrate clinical information from all sources — PMCF studies, post-market surveillance reports, vigilance data, published literature updates, and complaint analyses — into periodic CER updates. We define update triggers and review intervals, ensuring your clinical evaluation remains current and your device's benefit-risk profile is continuously validated against the evolving state of the art.
Clinical Affairs Deliverables
- Clinical evidence strategy and gap analysis report
- Literature search protocol with database search strategies
- Systematic literature review report with data extraction tables and quality appraisals
- Clinical Evaluation Report (CER) per MEDDEV 2.7/1 Rev 4 and MDCG guidance
- Clinical Evaluation Plan (CEP) with defined scope, methodology, and update schedule
- Equivalence demonstration document (technical, biological, clinical comparison)
- State of the art review and analysis
- Benefit-risk analysis with structured methodology
- Post-Market Clinical Follow-up (PMCF) plan per MDCG 2020-7
- PMCF study protocol, case report forms, and statistical analysis plan
- PMCF evaluation report per MDCG 2020-8
- Clinical Development Plan (for new devices or expanded indications)
- Periodic Safety Update Report (PSUR) clinical sections
- Summary of Safety and Clinical Performance (SSCP) for Class III and implantable devices
Applicable Standards & Regulations
EU MDR 2017/745
Articles 61-82 and Annex XIV establish the clinical evaluation and clinical investigation requirements for medical devices. Article 61 defines clinical evaluation methodology and evidence requirements, including the stringent conditions for equivalence-based evaluation. Annex XIV Parts A and B specify the requirements for clinical evaluation and PMCF respectively.
MEDDEV 2.7/1 Rev 4
The foundational guidance document for clinical evaluation of medical devices, establishing the staged methodology (Stages 0-5) for defining scope, identifying and appraising clinical data, analyzing evidence, and drawing conclusions on device safety and performance. While originally developed under MDD, its methodology remains the accepted standard for CER authorship under MDR.
ISO 14155:2020
The international standard for good clinical practice in clinical investigations of medical devices for human subjects. ISO 14155 defines requirements for clinical investigation planning, conduct, recording, and reporting, including ethical considerations, investigator responsibilities, sponsor obligations, and data management requirements.
MDCG 2020-5
Medical Device Coordination Group guidance on clinical evaluation under the MDR, providing practical interpretation of Article 61 requirements including clinical evaluation planning, selection of clinical data sources, assessment of clinical evidence adequacy, and specific considerations for different device types and risk classes.
MDCG 2020-6
MDCG guidance on sufficient clinical evidence for legacy devices, addressing the specific challenges manufacturers face when demonstrating clinical compliance for devices transitioning from MDD to MDR. The guidance provides a framework for assessing whether existing clinical evidence is sufficient or whether additional clinical data generation is required.
MDCG 2020-7 and 2020-8
Companion MDCG guidance documents on Post-Market Clinical Follow-up. MDCG 2020-7 provides the template and content requirements for the PMCF plan, while MDCG 2020-8 provides the template and content requirements for the PMCF evaluation report. Together they establish the framework for proactive, planned clinical data collection throughout the device lifecycle.
MDCG 2020-13
MDCG guidance on clinical evaluation assessment reports, defining the process and criteria notified bodies use to assess clinical evaluation documentation during conformity assessment. Understanding this guidance helps manufacturers anticipate notified body expectations and prepare documentation that addresses likely review questions proactively.
MDCG 2019-9 Rev 1
Guidance on the Summary of Safety and Clinical Performance (SSCP) required under MDR Article 32 for Class III and implantable devices. The SSCP must be validated by the notified body and made publicly available through EUDAMED, providing patients and healthcare professionals with transparent information about device safety and clinical performance.
Frequently Asked Questions
Related Services
Technical Documentation & CE Marking
Technical files, Design History Files, EU MDR/IVDR submissions, and FDA 510(k)/PMA
Learn moreRegulatory Strategy & Compliance
Regulatory roadmaps, pathway identification, MDR/IVDR transition, and notified body interaction
Learn moreM&A Due Diligence
Regulatory compliance audits, documentation reviews, and risk assessment for acquisitions
Learn moreReady to Accelerate Your Regulatory Compliance?
Schedule a free consultation with our senior regulatory experts