MDR (EU) 2017/745 IVDR Annexes I, II, III, XIII

Technical Documentation in Accordance with MDR & IVDR – Prepared in a Format Ready for Submission

Technical documentation is only ready for submission once all supporting evidence fits together consistently. We work with you to establish precisely this logical structure of evidence with a clear, consistent thread, in accordance with the MDR and IVDR.

25+ years of TechDoc experience · 200+ technical documentation projects · 100+ GSPR checklists

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Overview

Medical Devices (MDR)

In-Vitro Diagnostic Medical Devices (IVDR)

What is technical documentation—and what role does it play in conformity assessment?

The technical documentation contains the key evidence demonstrating that a medical device or in-vitro diagnostic medical device meets the applicable safety, performance, and conformity requirements. It forms the basis for the conformity assessment procedure and the evaluation by Notified Bodies and must be structured in a complete, consistent, and up-to-date manner in accordance with MDR or IVDR Annexes II and III.

The focus is not on individual technical documentations, but on the traceable linkage of all regulatory evidence: intended purpose, classification, GSPR, clinical evaluation or performance evaluation, verification and validation, labeling, PMS, and SSCP or SSP. Metecon structures this content so that the technical documentation is auditable and ready for submission.

Metecon supports you in the creation, structuring, and updating of MDR- and IVDR-compliant technical documentation with consistent documentation for Notified Bodies and conformity assessment procedures—from gap analysis through development to ongoing maintenance throughout the product life cycle.

EUROPE

CE Marking

MDR / IVDR - Eudamed registration

United States

FDA Approval

21 CFR 820 / QMSR

SWITZERLAND

CE Marking

MepV/IvDV – Swissdamed registration

AUSTRALIA

TGA Approval

ARTG registration

JAPAN

PMDA Approval

JPAL requirements

CANADA

Health Canada

CMDR requirements

Three Problems We Solve with the Technical Documentation

Our USP: Technical documentation with consistent traceability logic—featuring a clear, logical thread and the ability to be updated. What this means for you in concrete terms—and how Metecon supports you in this process:

Complete, but Inconsistent

Your technical documentation appears complete, but contradictory information triggers follow-up inquiries and back-and-forth exchanges with the Notified Body. Metecon creates a consistent documentation framework for you with a clear, coherent thread running through it.

Versions Turn into a Patchwork

Over the years, updates and changes create a patchwork—no one knows for sure which version is valid. Metecon establishes consistent versioning and clear validity for you.

Traceability Is Lost

Numerous or conflicting feedbacks from development, risk management, post-market surveillance, and the QMS can lead to an immense amount of work to implement changes. Metecon optimizes your processes and enables traceable documentation for robust technical documentation.

MDR vs. IVDR: What Are the Differences in the Technical Documentation?

7 Key Regulatory Aspects – Medical Devices vs. In-Vitro Diagnostic Medical Devices at a Glance

Aspect	Medical Devices (MDR)	In-Vitro Diagnostic Medical Devices (IVDR)
Legal Basis	MDR (EU) 2017/745 Annexes I–V & VIII	IVDR (EU) 2017/746 Annexes I–V & VIII
Risk Classes	I, IIa, IIb, III in accordance with MDR Article 51 and Annex VIII	A, B, C, D in accordance with IVDR Article 47 and Annex VIII
Clinical Evidence	clinical Evaluation (CER) in accordance with MDR Article 61 and Annex XIV	performance evaluation (PER) in accordance with IVDR Article 56 and Annex XIII
Post-market Reports	PMS report for class I, PSUR for class IIa and above, SSCP for class III and implants	PMS report for class A/B, PSUR and SSP for class C/D
Regulatory Framework	ISO 13485:2026, ISO 14971:2019, IEC 62366-1:2015 + COR1:2016 + A1:2020, ISO 10993-1:2025-11, IEC 62304:2006 + A1:2015	ISO 13485:2026, ISO 14971:2019, IEC 62366-1:2015 + COR1:2016 + A1:2020, IEC 62304:2006 + A1:2015
Special Features	biocompatibility assessment ISO 10993-1, systems, Procedure Packs	analytical performance, near-patient testing, companion diagnostics, in-house tests
Transition Periods	class III and IIb implants: through December 31, 2027; class I, IIa, IIb (non-implantable): through December 31, 2028	class D through December 31, 2027; class C through December 31, 2028; class B through December 31, 2029

Our 5-Step Methodology for Compliant Technical Documentation

Structured, transparent, and aligned with regulatory processes

Product Overview

intended purpose, classification, variants, target markets (EU + international)

Documentation Structure
structure in accordance with MDR/IVDR Annexes II and III

Documentation
GSPR, CER/PER, V&V, PMS, labeling

Consistency Check
Verification of all documentation prior to review by Notified Bodies

Ongoing Maintenance
updates (PMS, PMCF/PMPF, PSUR, SSCP/SSP, …)

Technical Documentation for MDR & IVDR: Our Services at a Glance

Creation & Maintenance

Complete technical documentation in accordance with MDR/IVDR—from gap analysis and GSPR mapping to digital documentation with an integrated PMS.

Risk Management & Documentation

Integration of regulatory risk assessments into the technical documentation—including traceability between the risk management file, V&V, CER/PER, and PMS.

Usability Engineering IEC 62366-1

Usability engineering file (UEF) for new and existing products, including formative and summative evaluation with a network of experienced partners.

Electrical Safety & EMC

Support for IEC 60601-1 and IEC 60601-1-2—from test planning and laboratory selection to integration into the technical documentation.

Cybersecurity

Cybersecurity documentation for networked medical devices, including risk assessment, software bill of materials (SBOM), and regulatory compliance with MDR/IVDR.

MDR (EU) 2017/745

Technical Documentation for Medical Devices in Accordance with the MDR

MDR-compliant documentation for medical devices—from GSPR and clinical evaluation to V&V, PMS, SSCP, and submission-ready documentation for Notified Bodies.

The MDR (EU) 2017/745 has replaced Directives 93/42/EEC (MDD) and 90/385/EEC (AIMDD). The first step in any revision of the technical documentation is a gap analysis of the general safety and performance requirements in Annex I to identify any supplementary or new evidence required.

Our Scope of Services for Technical Documentation in Accordance with the MDR

GSPR Mapping in Accordance with MDR Annex I

Systematic mapping of the general safety and performance requirements, including references to standards, verification references, and verifiable traceability within the technical documentation.

Clinical Evaluation (CER)

Preparation and updating of clinical evaluations in accordance with MDR Article 61 and Annex XIV—including literature reviews, clinical data, equivalence assessments, and consistency with PMS/PMCF.

Usability Evidence

Incorporation of evidence of usabillity in accordance with IEC 62366-1 into the technical documentation—as documented evidence of the safe use of the medical device.

Digital Documentation

Structured, searchable, and consistent technical documentation—for more efficient reviews by Notified Bodies and fewer inquiries during the assessment process.

Biological Evaluation EN ISO 10993-1

Incorporation of biological evaluation data in accordance with EN ISO 10993-1 into the technical documentation—aligned with the intended purpose, verification and validation (V&V), and clinical evaluation.

Verification and Validation (V&V) Documentation

Structured preparation of test plans, test results, acceptance criteria, and laboratory reports for technical documentation in accordance with MDR Annex II.

PMS and PSUR Documentation

Incorporation of post-market surveillance (PMS plan, PMS report, PSUR, etc.) into the technical documentation, including update cycles and consistency with the clinical evaluation.

SSCP (Class III + Implants)

Preparation and maintenance of the summary of safety and clinical performance—consistent with the clinical evaluation, PMS/PMCF, and technical documentation.

Consistency Check Before Submission

Verification of consistency between intended purpose, classification, GSPR, clinical evaluation, labeling, V&V, and PMS prior to review by the Notified Body.

Traceability: Seamless traceability between risk management, verification and validation (V&V), usability engineering, clinical evaluation, and PMS/PMCF data.
Risk Analysis: Systematic identification of hazards and hazardous situations, including structured hazard analyses even for complex medical devices.
Risk Assessment and Control: Assessment of probability of occurrence and severity, as well as the definition and verification of appropriate risk control measures.
Risk Management Plan: Definition of methodology, acceptance criteria, responsibilities, and the product life-cycle as the basis for all further risk management activities.
Risk Management Report: Assessment of residual risks and the overall benefit-risk ratio, prepared for review by the Notified Body
Workshops & Training: Support for interdisciplinary teams in implementing regulatory requirements for risk management in accordance with the MDR and ISO 14971—remotely or on-site.
Support for Audits / Nonconformities: Assistance with nonconformities, CAPAs, and inquiries from Notified Bodies—provided promptly and with a practical focus.

Usability Engineering File (UEF)

Complete usability engineering file (UEF) for newly developed products, existing products, and legacy devices in accordance with IEC 62366-1.

Analysis of the Usage Environment

Analysis of user profiles, use scenarios, and risks associated with user errors—as the foundation for all further usability activities.

Formative Evaluation

Usability evaluations conducted throughout the development process to identify design strengths and weaknesses, as well as usability and interface issues, at an early stage—carried out iteratively to ensure efficient product development.

Summative Evaluation

Validation of usability under realistic conditions of use—to demonstrate safe use and manageable risks associated with use.

Integration into Risk Management

Integration of the results from formative and summative evaluation with risk analysis and risk control in accordance with EN ISO 14971, including complete traceability.

Planning Your Studies with a Partner Network

Planning and coordination of laboratory, simulation, and application studies with validated partners, including project management by Metecon.

Electrical Safety & EMC: IEC 60601-1 and IEC 60601-1-2

For electrical medical devices, compliance with the IEC 60601 series is a key requirement for the technical documentation under the MDR.

Electrical safety and electromagnetic compatibility (EMC) are part of the general safety and performance requirements (GSPR) as specified in MDR Annex I and form the basis for every assessment conducted by the Notified Body.

IEC 60601-1 Electrical Safety

Demonstration of compliance with essential safety requirements—including protection against electric shock, mechanical hazards, and overheating.

IEC 60601-1-2 Electromagnetic Compatibility

Verification of electromagnetic compatibility (EMC), including immunity test levels for medical electrical devices and systems.

IEC 60601-1-11: Medical Care in the Home Environment

Requirements for medical devices used in home healthcare settings. Relevant for digital health devices, wearables, and home-use products.

Test Strategy and Laboratory Selection

Development of the testing strategy, selection of accredited testing laboratories, and integration of the test results into the technical documentation.

IEC 60601-1-6 Usability of Electrical Medical Devices

Linking the Usability Engineering File (UEF) to the requirements for electrical safety and risk control.

IEC 60601-1: Reports

Preparation of product-specific electrical safety reports as part of the technical documentation for active medical devices.

Cybersecurity: IEC 81001-5-1 and MDCG 2019-16

With the increasing connectivity of medical devices, cybersecurity is no longer an optional additional requirement but a regulatory component of the technical documentation. The MDR explicitly requires cybersecurity measures in Annex I, Section 17. MDCG 2019-16 specifies the expectations of Notified Bodies regarding connected medical devices and software as a medical device (SaMD).

IEC 81001-5-1 Cybersecurity for Healthcare Software

Cybersecurity requirements throughout the software life cycle, including threat analysis and risk assessment (TARA), cybersecurity requirements, verification, and documentation of the results.

TARA – Threat Analysis & Risk Assessment

Systematic analysis of threat scenarios, vulnerabilities, and attack vectors—a regulatory requirement for the technical documentation of networked medical devices and SaMD.

SBOM – Software Bill of Materials

A complete list of software components, dependencies, and SOUP libraries for software of unknown origin—increasingly required by Notified Bodies, the FDA, and international cybersecurity guidelines.

Cybersecurity Documentation in Technical Documentation

Integration of safety evidence into the technical documentation required under MDR Annex II, including interface documentation, labeling, and a patch management strategy.

MDCG 2019-16

Implementation of the European cybersecurity guidelines as the basis for assessment by Notified Bodies, including a regulatory gap analysis and a documentation strategy.

Cybersecurity, Risk Management & AI Act

Integration of safety risks into risk management in accordance with ISO 14971, as well as alignment of MDR, AI Act, and cybersecurity requirements within the technical documentation.

Note on the AI Act & Cybersecurity:

The AI Act imposes additional requirements on cybersecurity, risk management, and technical documentation for AI-based medical devices. Metecon provides support for the integrated implementation of MDR, AI Act, and cybersecurity requirements within a consistent technical documentation.

SSCP Requirement for Class III and Implants:

The summary of safety and clinical performance (SSCP) is a publicly available mandatory document under the MDR. It is validated by the Notified Body and published via EUDAMED. Metecon creates and maintains SSCPs as an integrated part of existing post-market surveillance processes.

Standards & Guidelines for Technical Documentation in Accordance with the MDR

MDR (EU) 2017/745 Annex II – Technical Documentation
MDR (EU) 2017/745 Annex III – Technical Documentation on Post-Market Surveillance (PMS and PMCF)
ISO 14971:2019 + A11:2021 Medical devices – Application of risk management to medical devices
IEC 62366-1:2015 + COR1:2016 + A1:2020 – Medical devices – Part 1: Application of usability engineering to medical devices
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 60601-1-6:2010 + A1:2013 + A2:2020 – Medical electrical equipment – Part 1-6: (usability engineering)
EN ISO 10993-1:2025-11 – Biological evaluation of medical devices – Part 1 (risk-based)
EN 62304:2006 + A1:2015 – Medical device software – Software life cycle processes (unit, integration, and system tests)
ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes
MEDDEV 2.7/1 Rev. 4 Clinical Evaluation: A Guide for Manufacturers and Notified Bodies under Directives 93/42/EEC and 90/385/EEC
MDCG 2020-5/-6/-7/-8 – MDR Guidelines for clinical evaluation
MDCG 2019-13 – Guidance on sampling of MDR Class IIa / Class IIb and IVDR Class B / Class C devices for the assessment of the technical documentation
IEC 60601-1-2:2014 + A1:2020 – Medical electrical equipment – Part 1-2: Collateral standard: Electromagnetic disturbances – Requirements and tests (Electromagnetic compatibility (EMC))
IEC 60601-1-11:2015 + A1:2020 – Particular requirements for safety, including essential performance – Collateral standard: Requirements for medical electrical equipment and medical electrical systems for home healthcare
IEC 81001-5-1:2021 Health software and health IT systems safety, effectiveness, and security – Part 5-1: Security – Activities in the product life cycle
MDCG 2019-16 Guidance on Cybersecurity for Medical Devices

Ready for submission:

We understand the expectations of the Notified Bodies.

Hourly billing:

Transparent cost estimate following a free initial consultation. Billing based on actual time spent and with maximum budget transparency.

Quick support for nonconformities:

Short-term support for nonconformities, CAPAs, and inquiries from Notified Bodies.

Complete traceability:

Consistency checks for intended purpose, risk management, labeling, and PMS within the TechDoc.

Hands-on support:

Direct collaboration with your team—from risk analysis and usability testing to a technical documentation ready for submission.

Interdisciplinary team:

Expertise in usability, biocompatibility, electrical safety, PMS, and cybersecurity—all integrated into a consistent TechDoc.

International:

Support with international regulatory requirements (such as FDA, TGA, etc.) based on existing documentation.

IVDR Annexes I, II, III, XIII

Technical Documentation under the IVDR: Legacy Devices, SSP, and Evidence of Conformity

The technical documentation under the IVDR imposes significantly higher requirements on performance evidence, PMS/PMPF documentation, and regulatory consistency than the previous directive. Manufacturers of existing IVDD products (legacy devices) must systematically update their technical documentation in accordance with IVDR Annexes II and III and prepare it in a format that can be reviewed by Notified Bodies.

Under the IVDR, Annex I now covers significantly more and more detailed essential safety and performance requirements. The proportion of IVDs whose technical documentation must be assessed by a Notified Body is estimated to rise from around 20% to over 80% (classes B–D). There is no grandfathering provision—from a regulatory perspective, the transition from the IVDD to the IVDR is equivalent to a first-time authorization.

IVDR Transition Periods: Which Products Must Be IVDR-Compliant by When?


Risk Class	NB Application Deadline	End of Transition Period	SSP Required
Class D ( highest risk)	May 26, 2025 (expired)	December 31, 2027	✓ Yes
Class C	May 26, 2026 (expired)	December 31, 2028	✓ Yes
Class B	May 26, 2027	December 31, 2029	No (PMS Report)
Class A (sterile)	May 26, 2027	December 31, 2029	No (PMS Report)

Our Scope of Services for Technical Documentation and Legacy Devices Under the IVDR:

Legacy Device Review: IVDD → IVDR

Systematic assessment of existing IVDD documentation with regard to IVDR requirements—including gap identification, evidence structure, and transition periods.

IVDR TechDoc Preparation

Preparation and structuring of technical documentation in accordance with IVDR Annexes II and III—from intended purpose and classification to a complete documentation trail.

MDCG Monitoring & Documentation Updates

Ongoing evaluation of relevant MDCG guidelines and common specifications—including consideration of regulatory changes for existing IVDR documentation.

Traceability

Consistent links between performance evaluation, PMPF, risk management file, V&V, and product labeling within the technical documentation.

SSP for Classes C & D

Preparation and maintenance of the summary of safety and performance (SSP) for class C and class D IVDs—in accordance with performance evaluation, PMS/PMPF, and MDR requirements.

PMS and PMPF Documentation

Incorporation of the PMS Plan, PMS Report, PMPF Plan, and PMPF Findings into the technical documentation in accordance with the IVDR.

PSUR (Classes C & D)

Preparation of the periodic safety update report (PSUR) for class C and class D IVDs—including a benefit-risk assessment, PMS data, and PMPF findings in accordance with the IVDR.

Communication with Notified Bodies

Preparation of regulatory submissions and structured support in responding to inquiries during the IVDR conformity assessment procedure.

The Three Pillars of Performance Evaluation Under the IVDR

Demonstration of the clinical performance of an IVD in accordance with IVDR Annex XIII is based on three pillars. As outlined in the performance evaluation plan (PEP), these culminate in three reports—scientific validity report (SVR), analytical performance report (APR), and clinical performance report (CPR)—which are consolidated in the performance evaluation report (PER).

All results must be fully documented in the technical documentation:

Scientific Validity

Evidence that the measured analyte is associated with a specific clinical or physiological condition. May be based on peer-reviewed literature, expert consensus, and scientific data.

Analytical Performance

A product’s ability to correctly detect or measure a specific analyte (accuracy, precision, analytical sensitivity, and specificity). Demonstrated through the company’s own studies or published data.

Clinical Performance

The ability of a product to produce results that correlate with a specific clinical condition or physiological or pathological process or condition in a specific target population and among specific intended users. Demonstrated through a clinical performance study in accordance with IVDR Annex XIII, scientific literature, peer review, or experience gained from routine diagnostic testing.

IVDR-specific risk classes:

Based on the intended purpose, devices are classified into risk categories A through D, with class D designated for high-risk devices.
Integration of Performance Evaluation:

Linking performance evaluation (PER) and risk assessment—particularly with regard to potentially erroneous test results and risks of diagnostic misinterpretation.
Link Between PMS and PMPF:

PMPF results and PMS data are continuously incorporated into the risk management file and the clinical performance evaluation.
Analytical validation risks:

Specific risks arising from insufficient limits of detection (LOD), cross-reactivity, and matrix interference are systematically identified and assessed.
FMEA for IVD-Specific Risk Analysis:

Assessment of analytical and diagnostic error risks using a structured FMEA methodology for complex IVD systems.

Usability Engineering File (UEF) for IVD

Complete usability engineering file for new IVD developments and legacy devices—either during development or retrospectively.

IVD-Specific Use Environment

Laboratory use vs. near-patient testing (point of care) vs. self-testing—different performance and safety requirements depending on the context of use.

IVD Studies Partner Network

Coordination of IVD performance studies with validated laboratories and study partners—planning, implementation, and documentation.

PMS/PMPF Integration

Usability findings derived from post-market surveillance (PMPF) are incorporated into the ongoing development of the usability engineering file (UEF)—a continuous process.

SSP Requirement for Classes C and D:

The summary of safety and performance (SSP) is the IVD equivalent of the summary of safety and clinical performance (SSCP) under the MDR. As a publicly accessible mandatory document for class C and class D IVDs, it is validated by the Notified Body and published in EUDAMED. Metecon prepares the SSP as part of your PER update cycle.

Standards & Guidelines for Technical Documentation Under the IVDR

IVDR (EU) 2017/746, Annexes II and III: Technical Documentation
IVDR (EU) 2017/746 Annex XIII – Performance Evaluation
ISO 14971:2019 + A11:2021 Medical devices – Application of risk management to medical devices
IEC 62366-1:2015 + COR1:2016 + A1:2020 – Medical devices – Part 1: Application of usability engineering to medical devices
MDCG 2022-2 – Guidance on general principles of clinical evidence for In Vitro diagnostic medical devices (IVDs)
MMDCG 2020-16 – Guidance on Classification Rules for In Vitro Diagnostic Medical Devices under Regulation (EU) 2017/746
Common Specifications (CS) for class D IVDs
CLSI Standards – Analytical performance

Our IVDR Performance Promise

Legacy Device Review & Update:

IVDD → IVDR: Systematic review and update of existing technical documentation for all risk classes.

MDCG Guideline Monitoring:

Ongoing evaluation of new MDCG guidelines and integration of relevant requirements into your documentation.

SSP for Class C/D:

Brief report on safety and performance, integrated into existing performance evaluation and PMS processes.

Traceability:

Consistent traceability from the product concept, specifications, performance evaluation, and technical documentation through to post-market surveillance.

Communication with Notified Bodies:

Coordination of the IVDR conformity assessment—including communication with Notified Bodies and testing laboratories.

Performance Evaluation According to the IVDR:

Scientific validity, analytical performance, and clinical performance are fully documented.

PMPF Integration:

PMPF findings are continuously integrated into performance evaluation, risk management, and the usability engineering file.

Stefan Kemmann

Team Lead, Regulatory Affairs & Technical Documentation · Metecon GmbH

Stefan Kemmann leads the Regulatory Affairs & Technical Documentation team at Metecon. The team supports manufacturers in the area of technical documentation by carrying out gap analyses and providing structured documentation development, from clear evidence management in accordance with MDR/IVDR Annexes II and III to technical documentation ready for submission. The team considers maintenance, traceability, future changes and expansion into new markets from the outset.

Meet all our experts

“Technical documentation can be formally complete yet still inconsistent, unclear, and poorly organized—and thus waste a lot of unnecessary time during the assessment. We’ll build a verification framework for you with a clear, consistent thread that anticipates inquiries from the Notified Body and also enables long-term maintenance of the technical documentation.”

– Stefan Kemmann, Team Lead, Regulatory Affairs & Technical Documentation, Metecon

What elements make up the technical documentation—and why is completeness alone not enough?

According to MDR/IVDR Annexes II and III, among other things, the product description, GSPR mapping, risk management, V&V, clinical evaluation or performance evaluation, labeling, and PMS must be included. However, consistency among these parts is crucial: Even if the technical documentation is formally complete, it can still contain contradictions—and that is precisely what leads to follow-up questions and iterative cycles during the evaluation process, ultimately resulting in delays in placing the device on the market.

How important is the structure of technical documentation—and how much flexibility is allowed in its design?

The MDR and IVDR specify the exact content requirements. What matters most is a clear, searchable structure with a logical thread that is aligned with the expectations and requirements of your Notified Body. Metecon develops a documentation structure tailored to your product portfolio and QMS—robust evidence-based logic rather than a document landscape that has evolved haphazardly over time.

How can you tell if existing technical documentation is consistently linked to the quality management processes?

Key indicators include consistent versioning, clearly defined document validity periods, and traceability that links requirements, risks, verification and validation (V&V), and claims. When documents are not linked to one another, questions arise. In a gap analysis, Metecon examines whether the document control and change management processes of your QMS are aligned with your technical documentation—and closes any gaps.

How can risk management results be integrated in a way that ensures changes remain traceable?

Risk analysis, risk control, and residual risk assessment in accordance with ISO 14971 are linked to V&V, clinical evaluation or performance evaluation, usability, and PMS. This ensures that, for every change, it is clear which supporting documentation is affected. Metecon embeds these links in the QMS and in the technical documentation, ensuring that changes are evaluated and consistently tracked—without a patchwork approach.

How can evidence from verification and validation be reliably incorporated into the technical documentation?

Test plans, acceptance criteria, and test reports must be traceable to requirements, risks, and claims. Metecon structures the verification and validation documentation so that the Notified Body can trace the chain from the requirement through the test to the result.

How can we restore the reliability of patchwork documentation that has evolved over time?

Typical symptoms of patchwork documentation that has evolved over time include unclear responsibilities, conflicting content, and a lack of traceability. Metecon consolidates such records into a consistent documentation framework with a clear overarching theme. The starting point is a gap analysis that prioritizes what needs to be supplemented, corrected, or newly linked.

How can technical documentation remain consistent when PMS, vigilance, or CAPA trigger changes?

Findings from PMS and PMCF/PMPF, vigilance, and CAPA must be incorporated into risk assessment, clinical evaluation or performance evaluation, labeling, and, where applicable, SSCP/SSP. Metecon sets up the QMS and technical documentation to be updatable, ensuring that market-driven changes are incorporated in a structured and traceable manner—the file remains a living, valid document.

Which components make up the technical documentation—and why is completeness alone not enough?

According to MDR/IVDR Annexes II and III, among other things, the product description, GSPR mapping, risk management, V&V, clinical evaluation or performance evaluation, labeling, and PMS are included. However, consistency among these parts is crucial: A formally complete technical documentation can still contain contradictions—and that is precisely what leads to inquiries and iterative cycles during the evaluation.

Which factors determine the cost of creating or revising a project at Metecon?

The key factors are risk class, product complexity, the quality and recency of the available data, and the extent of the gaps. Metecon begins with a gap analysis and then prepares a cost estimate—one that is predictable and budget-transparent. The process starts with a free initial assessment.

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