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Medical Devices (MDR) In-Vitro Diagnostics (IVDR)DAkkS · ISO 17025 · ISO 20916

Verification & Validation in Accordance with MDR and IVDR – Risk-Based Testing, Fully Traceable

Many V&V programs result in an enormous testing burden and still leave gaps because requirements, risks, and evidence are not consistently linked. We structure your verification and validation in a risk-based manner and ensure that requirements, risks, tests, and results are fully traceable—anchored in technical documentation and the QMS, without overengineering and without gaps.

25+ years of experience · 300+ V&V projects · accredited laboratory network
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Frequently Asked Questions →
25+
Years of V&V experience
300+
V&V Projects for MD and IVD
IEC 62304 &
ISO 20916
MDR + IVDR
Expertise

Verification and Validation Under the MDR and IVDR: Differences and Requirements

Verification and validation are distinct but inextricably linked mandatory activities under the MDR and IVDR.

Traceability as a Service Concept: Requirements, Risks, and Evidence Seamlessly Linked

Verification and validation are not simply a matter of running through a series of isolated tests. We translate requirements and risks into a risk-based test strategy with verifiable acceptance criteria and consolidate the results in such a way that every requirement and every risk remains fully traceable all the way through to verification—anchored in technical documentation and the QMS, without overengineering and without gaps.

Requirement / Risk    Acceptance Criterion    Risk-Based Test Strategy    Verification & Validation    Verification · TechDoc & QMS & QMS

Feedback: Product changes, revalidation activities, and post-market findings are incorporated in a controlled manner while maintaining traceability.

Instead of treating tests merely as isolated tasks, we coordinate test strategy, execution, and documented evidence management from a single source: Risks determine the depth of testing, acceptance criteria are defined in advance, and the traceability matrix links requirements, risks, tests, and results in a consistent manner—even for software (IEC 62304), usability, and AI systems.

Verification & Validation at Metecon

“V&V with consistent traceability – requirements, risks, and evidence linked in a traceable manner.”

Three Challenges and How Metecon Can Help You

Three practical challenges that a risk-based, traceable V&V solves—and how we implement it for you.

The scope of testing is not risk-based

Either a significant effort with no gain in insight, or gaps that will require rework later on.

For you: We determine the scope of testing and priorities based on risks and acceptance criteria—in a targeted manner rather than a one-size-fits-all approach.

Traceability is missing

Requirements and risks are not consistently linked to tests and results.

For you: We build a comprehensive traceability matrix that ensures changes can be evaluated in a controlled manner.

Unplanned V&V Activities

Unplanned but necessary measures prolong development and increase costs.

For you: We plan verification and validation (V&V) early on to avoid late rework and schedule risks.

The V-Model in the Verification and Validation of Medical Devices

The V-Model is a well-established development and testing model for medical devices and software.
In regulatory projects, it is used in particular in connection with IEC 62304 and IEC 60601-1.

The V-Model According to IEC 62304

Left side = Requirements (specification) · Right side = Tests (Verification & Validation)

Stakeholder Requirements
What the user needs (intended purpose)

Traceability

Validation
Summative usability, clinical performance

System Requirements
What the product must be able to do

System Tests
Verify integration into the overall product

Software Requirements
Functional and non-functional software requirements

Integration Tests
Interaction between software modules

Component Design
Detailed design of modules and units

Unit Tests
Testing individual software components

Verification checks whether requirements are met.
Validation checks whether the product fulfills its purpose.

V&V According to the MDR vs. the IVDR: Differences at a Glance

Both regulations require verification and validation—with different areas of focus. For IVDs, there are additional requirements regarding the performance evaluation.

MDR vs. IVDR: V&V Requirements

 

Criterion Medical Devices (MDR) In-Vitro Diagnostic Medical Devices (IVDR)
Legal Basis MDR (EU) 2017/745 Annex I (GSPR) + Annexes II/III IVDR (EU) 2017/746 Annex I (GSPR) + Annex XIII
Standards Framework MDR: IEC 62304, IEC 60601-1, and other product-specific testing standards IVDR: IVDR Annex XIII (SVR, APR, CPR), ISO 20916, CLSI EP documents
V-Model / Process product-specific tests (mechanical, biological, and electrical safety, sterility, etc.) analytical performance evaluation (APR) + clinical performance study (CPR)
Software IEC 62304 mandatory + IEC 82304-1 for standalone software IEC 62304 applies to IVD software
External laboratories biocompatibility, EMC, electrical safety, sterility (DAkkS/ISO 17025) analytical validation, clinical performance studies (ISO 20916)
Process validation validation of relevant manufacturing processes analytical method validation
Key guideline MDCG 2020-1 (software) MDCG 2022-2 (performance evaluation)
Transition periods
 MDR is in effect—current recertifications are underway class D through 2027 · class C through 2028 · class B and A (sterile) through 2029

 

Achieving Audit-Ready V&V Documentation in 5 steps

1

Requirements Analysis
determination of intended purpose, standards, and risk class
2

Test Strategy
scope of testing, GSPR mapping, internal vs. external
3

Verification
in-house testing + accredited external laboratories
4

Validation
check of intended purpose and context of use
5

V&V Documentation
comprehensive documentation and traceability

Our V&V Services at a Glance

Test Strategy & V&V Plan

risk-based scope of testing, GSPR mapping, selection of standards (IEC 62304, IEC 60601-1, etc.), V&V concept, and detailed test specifications

Software Verification and System Testing (IEC 62304)

unit tests, integration tests, and system tests in accordance with IEC 62304; supplemented by IEC 82304-1 as needed

External Laboratories & Coordination

accredited laboratory network (DAkkS, ISO 17025): biocompatibility, EMC, electrical safety, sterility-full coordination

IVD: SVR · APR · CPR

all three IVDR performance evaluation pillars: scientific validity, analytical performance (CLSI), and clinical performance (ISO 20916)

Verification & Validation for Medical Devices in Accordance with the MDR

Verification and validation demonstrate that medical devices meet the defined requirements for safety, performance, and their intended purpose. Metecon supports manufacturers in the planning, coordination, and documentation of regulatory-relevant testing and evaluation activities in accordance with the MDR.

MDR Annex I (GSPR): V&V is mandatory for every product class

The general safety and performance requirements (GSPR) set forth in MDR Annex I must be demonstrated through V&V activities—for all classes I through III.

V&V Planning and Test Strategy: Our Scope of Services

Verification and Validation Plan and Test Strategy in accordance with ISO 13485, Clause 7.3

systematic V&V design: risk-based scope of testing, GSPR mapping, selection of standards (IEC 62304, IEC 60601-1, ISO 10993, etc.), and testing strategy for internal and external testing.

Traceability Matrix

full traceability of requirements, tests, and results—documented in a transparent manner and consistent with the V&V strategy.

Test Specifications and Test Reports

development of test specifications that comply with standards (test cases, test steps, acceptance criteria) and traceable test reports with an evaluation of results.

Design Change Management and Re-Verification

impact analysis for product changes: Which tests need to be repeated or supplemented? A risk-based re-testing approach to avoid unnecessary repeat testing.

Quick Fix: Close V&V Gaps Before the BS Audit

short-term support for V&V gaps, additional requirements, and incomplete test documentation—practical and compliant with regulatory requirements.

Clinical trials in accordance with MDR Annex XV as a V&V option

If preclinical data and existing evidence are insufficient, clinical trials in accordance with Article 62 of the MDR may be required. Metecon provides support with regulatory classification and integration into the V&V strategy.

Software Validation According to IEC 62304: A Common V&V Gap in NB Audits

IEC 62304 requires structured testing at the unit, integration, and system levels—supplemented by IEC 82304-1 for standalone software. Metecon systematically addresses these gaps.

Software Verification and System Testing in Accordance with IEC 62304 and IEC 82304-1

  • IEC 62304 Software Life Cycle and V&V Activities

    IEC 62304 defines the mandatory test activities depending on the software safety class (A, B, C): unit tests (components), integration tests (modules), and software system tests (entire system). According to Amendment 1 (2015), software system tests are mandatory for all classes. Metecon plans, designs, and documents all required test activities—in compliance with standards and suitable for Notified Bodies. ISO 14971 measures regarding software are verified, regardless of the safety class.

  • IEC 82304-1: Standalone Software (SaMD)

    Software as a Medical Device (SaMD) is additionally subject to IEC 82304-1 for health software. Metecon provides support for validation in accordance with MDCG 2020-1 and for demonstrating clinical performance for SaMD products.

  • Computer System Validation (CSV)

    ISO 13485 clause 4.1.6 requires the validation of QMS software. Metecon creates CSV plans, CSV decision matrices, and IQ/OQ/PQ protocols for ERP, eQMS, LIMS, and production software.

  • Cybersecurity in the V&V Context

    IEC 81001-5-1 and MDCG 2019-16: security testing (penetration testing, SBOM analysis) as part of software V&V activities. Integration into the technical documentation in accordance with MDR Annex II.

  • AI Act & ML Validation for SaMD

    AI-based software classified as a medical device imposes additional requirements for verification, validation, and performance monitoring. Metecon takes current regulatory requirements such as MDCG 2020-1 and the EU AI Act into account in the V&V context.

External Laboratories: Coordination Is the Key Time Factor

Laboratory bottlenecks can delay approval by months. Metecon coordinates your entire external testing program—selection, scheduling, sample management, and results evaluation—all from a single source.

External Laboratories: Accredited Testing Network for Medical Devices

Metecon does not operate as a laboratory—we coordinate. Our network of accredited testing institutes (DAkkS, ILAC members, ISO 17025) covers all key testing areas:

What Metecon Does as a Coordinator

Laboratory selection · Technical coordination of test specifications · Sample and equipment coordination · Interface management · Regulatory interpretation of results · Structured provision of test reports for V&V documentation.

Biological Evaluation ISO 10993 – GLP-Compliant Laboratories

Coordination of regulatory-relevant testing in accordance with ISO 10993 at accredited testing laboratories.

EMC & Electrical Safety

IEC 60601-1-2 (EMC), IEC 60601-1 (Electrical Safety), IEC 60601-1-11 (home healthcare environment): test planning, laboratory selection, and integration of results in TechDoc.

Sterilization & Packaging

Validation of sterilization and packaging processes is performed in accordance with relevant standards, depending on the product, packaging system, and intended purpose. Metecon provides support with test coordination and the documentation of regulatory evidence.

DAkkS Accreditation & ISO 17025 / GLP

Only DAkkS-accredited laboratories or those accepted as equivalent (ILAC members). Biocompatibility testing is conducted exclusively in GLP-certified laboratories. Metecon verifies the scope and validity of accreditation prior to placing an order.

Physical & Mechanical Tests

Coordination of mechanical and physical tests: for example, compressive strength, fatigue tests, protection class (IP rating) according to IEC 60529, drop tests, vibration, and environmental testing.

Process Validation: Manufacturing Processes and QMS Software as a Mandatory Requirement

ISO 13485 clause 7.5.6 requires the validation of all processes whose results cannot be, or are not, fully verified through subsequent monitoring.

Process Validation and Computerzed System Validation (CSV) in the Context of V&V

  • Manufacturing Process Validation (ISO 13485 Clause 7.5.6)

    Mandatory validation for processes without complete verification of results: sterilization, coating, welding, filling of sterile products, bonding. IQ/OQ/PQ protocols, statistical validation approaches.

  • Computerized System Validation (CSV)

    ISO 13485 clause 4.1.6: Validation of all QMS-relevant software tools; 7.5.6 Process validation for manufacturing; 7.6 Software validation for monitoring and measuring equipment; CSV Decision Matrix; IQ/OQ/PQ for eQMS, ERP, LIMS, PLM. GAMP 5 principles as a reference. Metecon creates the complete CSV plan and provides support during implementation.

  • Summative Usability Evaluation (IEC 62366-1)

    Support for summative usability evaluations in accordance with IEC 62366-1, including test planning, execution, and integration of the results into the V&V documentation.

Standards & Guidelines: Verification and Validation of Medical Devices (MDR)

  • MDR (EU) 2017/745 – Annex I (GSPR), Annex II (technical documentation)
  • MDR (EU) 2017/745 Article 62 + Annex XV – clinical investigations as a V&V option
  • EU AI Act Regulation (EU) 2024/1689 on artificial intelligence (high-risk AI Systems: V&V requirements for SaMD with ML)
  • IEC 62304:2006 + A1:2015 – Software life-cycle processes (unit, integration, and system tests)
  • IEC 82304-1:2016-10 – Health software—Part 1: General requirements for product safety (standalone software (SaMD))
  • IEC 60601-1:2005 + Cor1:2006 + Cor2:2007 + A1:2012 + A1:2012/Cor1:2014 + A2:2020 – Medical electrical equipment – Part 1 (electrical safety of medical equipment)
  • IEC 60601-1-2:2014 + A1:2020 – Medical electrical equipment – Part 1-2: Collateral standard: Electromagnetic disturbances – Requirements and tests (Electromagnetic compatibility (EMC))
  • IEC 60601-1-6:2010 + A1:2013 + A2:2020 – Medical electrical equipment – Part 1-6: Collateral standard: Usability (active electrical medical devices)
  • IEC 60529:1989 + A1:1999 + A2:2013 – Degrees of protection provided by enclosures (IP Code) (physical testing)
  • ISO 10993-1:2025-11 – Biological evaluation of medical devices – Part 1 (risk-based)
  • ISO 11135:2014 + Amd.1:2018 Sterilization of health-care products—Ethylene oxide
  • ISO 11137-1:2006 + Amd. 1:2013 + Amd. 2:2018: Sterilization of health care products—Radiation—Part 1 (EO, radiation)
  • ISO 11137-2:2013 + Amd 1:2022: Sterilization of health care products—Radiation—Part 2 (sterilization dose)
  • ISO 11607:2019 + Amd. 1:2023  Packaging for terminally sterilized medical devices — Part 1
  • ISO 13485:2016 Medical devices—Quality management systems—Requirements for regulatory purposes (4.1.6 Validation of QMS software, 7.5.6 Validation of manufacturing software, 7.6 Validation of measuring equipment software)
  • ISO 14971:2019 + A11:2021 Medical devices — Application of risk management to medical devices (basis for V&V scope of testing)
  • ISO/TR 80002-2:2017-06 Medical device software—Part 2: Validation of software for use in quality assurance for medical devices
  • IEC 81001-5-1:2021 – Healthcare Software and Healthcare IT Systems: Safety, Effectiveness, and Security – Part 5-1: Security – Activities Throughout the Product Life Cycle (IT Security / Cybersecurity)
  • GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition) (CSV)
  • MDCG 2020-1 – Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software
  • MDCG 2019-16 Guidance on Cybersecurity for Medical Devices

Verification & Validation for IVDs under the IVDR

IVDR Annex XIII defines requirements for scientific, analytical, and clinical performance evidence. Metecon provides support for the planning, coordination, and documentation of this evidence in accordance with MDCG 2022-2.

IVDR Transition Periods:

Extended transition periods apply to certain IVDR legacy devices under defined conditions. Evidence of compliance should be prepared well in advance.

Demonstration of Scientific Validity and Analytical and Clinical Performance in Accordance with the IVDR

The pieces of evidence complement each other depending on the product type, intended purpose, and risk class.

1

Scientific Validity (SVR)

Scientific performance data support the demonstration of the medical and diagnostic relevance of an IVD in its intended context of use.

2

Analytical Performance (APR)

Analytical performance studies evaluate the technical performance parameters and reliability of an IVD under defined test conditions.

3


Clinical Performance (CPR)

Clinical performance data support the demonstration of an IVD’s diagnostic performance in the intended target population.

Scientific Validity (SVR): How Metecon Supports IVD Manufacturers

Systematic Literature Review According to MDCG 2022-2

Protocol-based literature search in medical databases (PubMed, EMBASE, etc.) to demonstrate the analyte-status relationship. Assessment of data quality, currency, and relevance according to MDCG 2022-2 requirements. Fully documented for the PER.

Documentation of Scientific Validity Evidence in Accordance with MDCG 2022-2

Complete SVR in the MDCG 2022-2-compliant format: description of the analyte, target population, diagnostic question, literature summary, state of the art, assessment of scientific validity, and conclusion.

SVR Update in the PMPF Cycle

Existing scientific evidence can be updated with new literature and post-market surveillance data.

APR According to CLSI Protocols: Demonstration of Analytical Performance for IVD

CLSI EP protocols are the internationally recognized standard for analytical performance studies. CLSI-compliant APR reports make it easier to demonstrate compliance with the state of the art.

APR – Analytical Performance Report According to CLSI Protocols

Metecon provides support for the planning, coordination, and regulatory documentation of analytical performance testing in accordance with CLSI EP protocols.

CLSI EP17-A2

Determine LOD & LOQ

Limit of detection (LOD) and limit of quantitation (LOQ)—determined precisely according to the CLSI protocol for each matrix.

CLSI EP5-A3

Precision (Repeatability & Reproducibility)

Intra-laboratory precision and inter-laboratory precision according to CLSI EP5: repeatability, within-lab precision.

CLSI EP9-A3

Comparison of Methods & Accuracy

Comparison of test method vs. reference method: systematic deviations, proportionality errors.

CLSI EP6-A

Linearity & Measurement Range

Verification of the linear measurement range and analytical measurement interval (AMI) according to CLSI EP6.

CLSI EP7-A2

Interferences & Cross-Reactivities

Systematic testing for potential interfering substances (hemoglobin, bilirubin, lipids, etc.) and cross-reactivities.

CLSI EP25-A

Shelf Life & Stability

Reagent shelf life under various storage conditions – required for IVDR compliance.

ISO 20916: Clinical Performance Study for IVD—When and How?

If APR and literature data are insufficient, a clinical performance study conducted in accordance with ISO 20916 provides the necessary evidence. Metecon provides support for the regulatory planning, design, and classification of clinical performance studies in accordance with ISO 20916.

CPR – Clinical Performance Evidence in Accordance with ISO 20916

Clinical Performance Parameters: Sensitivity, Specificity, PPV/NPV, ROC

Evidence of diagnostic performance in the target population: clinical sensitivity and specificity (vs. the reference standard), predictive values (PPV/NPV at realistic prevalence), ROC curve analysis. Fully documented in the clinical performance report (CPR) in accordance with IVDR Annex XIII 1.2.3.

Clinical Performance Study Plan (CPSP) in Accordance with ISO 20916

Support in planning clinical performance studies in accordance with ISO 20916, including study design and data analysis strategy.

Ethics Review, Regulatory Approval, and Study Registration

Support with regulatory requirements for clinical performance studies, including ethics committee and regulatory agency processes.

Study Conduct and Sample Management

Coordination of regulatory-related processes in the context of clinical performance studies.

Statistical Analysis and Clinical Performance Report

Support for the analysis and documentation of clinical performance data in a regulatory context.

PMPF: CPR Update Through Post-Market Performance Follow-up

Post-market surveillance data can supplement and update existing performance data.

MDCG 2022-2: The Key Guideline for all IVDR Performance Evaluations

Notified bodies evaluate PER documents against MDCG 2022-2. Metecon Standard: All SVR, APR, and CPR reports are prepared in accordance with MDCG 2022-2.

MDCG 2022-2: Requirements for Performance Data Under the IVDR

  • What is MDCG 2022-2?

    MDCG 2022-2, “Guidance on general principles of clinical evidence for IVDs,” specifies the IVDR requirements for SVR, APR, and CPR from a NB perspective: acceptable data sources, distribution of the burden of proof by risk class, and minimum requirements for literature data and studies.

  • Scope of Clinical Evidence by Risk Class

Class A: literature data is usually sufficient. Class B/C: literature data is often supplemented by proprietary studies. Class D: literature data, proprietary studies, involvement of EU reference laboratories. Metecon is familiar with the NS expectations for each class.

  • Acceptable Data Sources According to MDCG 2022-2

    Peer-reviewed literature, routine diagnostic data, proprietary performance studies (ISO 20916), registry data, post-market data. Metecon evaluates your existing data and identifies gaps—before you undertake a costly study.

  • PER Structure According to MDCG 2022-2

    Performance evidence must be structured in a traceable manner and documented consistently.

Standards & Guidelines: Verification and Validation of In-Vitro Diagnostic Medical Devices (IVDR)

  • IVDR (EU) 2017/746 – Annex XIII (SVR, APR, CPR as the basis for V&V)
  • MDCG 2022-2 – Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs)
  • ISO 20916:2019 – In vitro diagnosticmMedical devices — Clinical performance studies using human specimens — Good study practice
  • CLSI EP17-A2 – Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures (Determination of LOD and LOQ)
  • CLSI EP5-A3 – Evaluation of Precision of Quantitative Measurement Procedures (precision performance, experimental designs)
  • CLSI EP9-A3 – Measurement Procedure Comparison and Bias Estimation Using Patient Samples (method comparison and accuracy)
  • CLSI EP6-A – Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach (linearity and analytical measurement range)
  • CLSI EP7-A2 – Interference Testing in Clinical Chemistry (interferences and cross-reactivities)
  • IEC 62304:2006+A1 – Software Life Cycle Processes (unit, integration, and system tests)
metecon-julian-raum

Julian Raum

Expert Regulatory Affairs & Technical Documentation, Medical Devices · Metecon GmbH

Julian Raum is a seasoned Metecon expert specializing in the verification and validation of medical devices. Since 2016, he has been supporting projects from the derivation of regulatory, normative, and product-specific requirements through the development of suitable test strategies to the execution and documentation of verification and validation. Our V&V team’s focus: to consistently link requirements, risks, tests, and results, and to ensure that the necessary traceability is consistently reflected in the technical documentation and the quality management system.

Meet all our experts

"Requirements, risks, and evidence clearly and traceably linked—together with you, we’ll develop the verification and validation (V&V) strategy that’s right for you, with consistent traceability."

– Julian Raum, Expert Regulatory Affairs & Technical Documentation, Metecon

metecon-sandra-reuter

Dr. Sandra Reuter

Team Lead, IVD · Metecon GmbH

Dr. Sandra Reuter leads the IVD team at Metecon and has more than 20 years of experience in the development and regulatory evaluation of in-vitro diagnostic medical devices, including several years as a regulatory affairs manager in the industry. Together with her team, she supports manufacturers in planning, conducting, and documenting verification and validation activities for IVDs. A key focus is on analytical performance studies and the consistent alignment of performance requirements, study design, results, and performance evaluation.

Meet all our experts

"Performance studies provide reliable evidence only if performance requirements, study design, acceptance criteria, and evaluation are consistently aligned. It is precisely this alignment that must subsequently be reflected in the performance assessment."

– Dr. Sandra Reuter, Team Lead IVD, Metecon

Frequently Asked Questions About the Verification and Validation of Medical Devices and IVDs

What is the difference between verification and validation with regard to medical devices?

Verification checks whether a product meets the specified requirements (e.g., Does the defibrillator deliver 3,000 V?). Validation verifies whether the product fulfills its intended purpose and meets the needs of users in the target environment (e.g., Is the heart beating after use?). Together—V&V—they are mandatory components of the technical documentation according to MDR Annex I and IVDR Annex I.
What is the V-Model, and how does it apply to medical devices under the MDR?

The V-Model is the reference model for structured medical device development in accordance with IEC 62304 and IEC 60601-1. The left side describes the requirement levels (from stakeholder requirements to component design), while the right side describes the corresponding test activities (from unit tests to validation). Each requirement has a direct test activity. Traceability between requirements and tests is mandatory.
What is software validation according to IEC 62304?

IEC 62304 governs the software lifecycle for medical devices and IVDs. Software validation includes unit tests (components), integration tests (modules), and system tests (entire system). According to Amendment 1 (2015), system tests are mandatory for all safety classes. IEC 82304-1 provides additional requirements for standalone medical device software (SaMD). CSV in accordance with ISO 13485 Section 4.1.6 applies to the QMS infrastructure.
What are the three pillars of the IVDR performance evaluation (SVR, APR, CPR)?

IVDR Annex XIII defines three types of mandatory evidence:

1) Scientific validity (SVR): Relationship between analyte and medical condition based on a literature review.

2) Analytical performance (APR): Technical parameters such as LOD/LOQ, sensitivity, specificity, and precision, e.g. according to CLSI protocols.

3) Clinical performance (CPR): Diagnostic performance in the target population, if applicable, through a clinical performance study in accordance with ISO 20916.
What is ISO 20916, and when is a clinical performance study required for IVDs?

ISO 20916 (good clinicalpPractice for clinical performance studies) is the standard for the planning, conduct, and documentation of clinical performance studies for IVDs. A dedicated study is required if there are insufficient literature data, routine diagnostic data, or historical data to demonstrate clinical performance. Metecon prepares the clinical performance study plan (CPSP) and coordinates the ethics committee approval and study conduct.
What is MDCG 2022-2, and why is it important for IVD manufacturers?

MDCG 2022-2 is the EU’s key guideline on the performance evaluation of IVDs under the IVDR. It specifies the NB’s expectations regarding SVR, APR, and CPR: the distribution of the burden of proof by risk class, acceptable data sources, minimum requirements, and the PER structure. All Metecon performance evaluation reports are based on MDCG 2022-2.
What is a test strategy, and how does it differ from a V&V plan?

The test strategy (V&V concept) defines the overall testing approach: applicable standards, test methods, risk classes, scope of testing, and internal vs. external testing. The V&V plan specifies these details for a specific product: concrete test cases, test specifications, and acceptance criteria.
What are CLSI protocols, and why are they relevant to analytical IVD validation?

CLSI (Clinical and Laboratory Standards Institute) EP protocols are the international standards for analytical IVD validation: EP17 (LOD/LOQ), EP5 (precision), EP9 (interlaboratory comparison), EP6 (linearity), EP7 (Interferences). Notified bodies expect CLSI-compliant APR reports make it easier to demonstrate compliance with the state of the art.
Which external laboratories are suitable for testing medical devices?

Accredited testing laboratories (DAkkS in Germany, ILAC members internationally) conduct tests in accordance with ISO 17025, such as biocompatibility (ISO 10993), EMC (IEC 60601-1-2), electrical safety (IEC 60601-1), and sterilization (ISO 11135/11137). Therefore, laboratories that can demonstrate this accreditation for the relevant test methods are generally suitable. Metecon coordinates the selection of laboratories, manages interfaces, and integrates laboratory reports into the technical documentation.

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T: +49 621 123469-040
milan.weiss@metecon.de

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