Published: 13th July 2026
Reviewed by: David Small BSc (Hons), MSc, MTOPRA (Founder and CEO)
Technical Documentation Quality Matters More Than Ever
The introduction of the European Medical Device Regulation (EU MDR 2017/745) and In Vitro Diagnostic Medical Device Regulation (EU IVDR 2017/746) has fundamentally changed how medical devices and IVDs are assessed before they can be placed on the European market.
Notified Bodies are no longer reviewing technical documentation simply to confirm that the required documents exist. Instead, they assess whether every element of the technical documentation demonstrates a coherent, evidence-based justification that the device is safe, performs as intended and complies with the applicable General Safety and Performance Requirements (GSPRs).
While every conformity assessment is unique, many of the observations raised during technical documentation reviews follow familiar patterns.
In our experience supporting manufacturers with MDR and IVDR technical documentation, the majority of review comments are not caused by missing documents. They arise because different parts of the technical file fail to support one another consistently.
Clinical evidence may not align with risk management.
Post-market surveillance activities may not monitor identified residual risks.
Performance claims may not be fully supported by the available evidence.
Administrative information may differ across documentation.
These issues often result in multiple rounds of questions from the Notified Body, extending certification timelines and increasing project costs.
Fortunately, many of these deficiencies can be identified and corrected before submission.
Below are ten of the most common technical documentation deficiencies encountered during MDR and IVDR reviews.
New to the EU Medical Device Regulation?
This article focuses on common technical documentation deficiencies identified during Notified Body reviews. If you're looking for a complete introduction to the EU MDR, including device classification, General Safety and Performance Requirements (GSPRs), Technical Documentation, Clinical Evaluation, Risk Management, UDI, EUDAMED and post-market surveillance, read our Complete Guide to the EU MDR.
Working with In Vitro Diagnostic Devices?
This article covers common technical documentation deficiencies identified during both MDR and IVDR Notified Body reviews. If you're looking for a complete introduction to the In Vitro Diagnostic Medical Devices Regulation (IVDR), including classification, Performance Evaluation, Technical Documentation, Notified Bodies, UDI, EUDAMED and post-market requirements, read our Complete Guide to the EU IVDR.
1. Weak State of the Art Justification
One of the earliest areas reviewed during Clinical Evaluation or Performance Evaluation is the State of the Art (SOTA).
Unfortunately, many manufacturers still treat this section as a general introduction describing the device or the technology.
Notified Bodies expect considerably more.
A robust State of the Art review should establish the current accepted clinical practice, relevant medical guidelines, existing technologies and measurable performance expectations against which the subject device can be assessed.
Without clearly defining the current standard of care, it becomes difficult to justify claims that the device offers an acceptable benefit-risk profile or performs comparably to existing solutions.
Rather than viewing State of the Art as an isolated chapter, it should provide the scientific foundation for the entire Clinical Evaluation or Performance Evaluation.
Need Help with Clinical Evaluation?
Clinical Evaluation Reports (CERs) remain one of the most frequently scrutinised elements of MDR technical documentation. Learn how to prepare a compliant Clinical Evaluation that demonstrates your device's safety, clinical performance and benefit-risk profile by reading our Complete Guide to Medical Device Clinical Evaluation.
2. Clinical and Performance Claims Are Not Adequately Supported
Manufacturers understandably wish to highlight the strengths of their products.
However, statements such as:
- Improves patient outcomes
- Provides accurate results
- Delivers superior performance
- Reduces complications
must always be supported by objective evidence.
Notified Bodies increasingly scrutinise every performance and safety claim appearing within technical documentation, Instructions for Use, labelling and promotional material.
Where claims cannot be directly supported by clinical evidence, analytical performance data or published literature, clarification requests are almost inevitable.
Strong technical documentation demonstrates not only that evidence exists, but that the evidence directly supports each claim being made.
Consistency between intended purpose, clinical evidence and marketing claims is becoming increasingly important under both MDR and IVDR.
3. Technical Documentation Is Written in Isolation
One of the most common observations raised during conformity assessment has nothing to do with scientific evidence.
Instead, it relates to consistency.
Large technical documentation projects often involve multiple authors working independently.
Clinical specialists prepare the Clinical Evaluation.
Engineers maintain Risk Management.
Quality teams update Post-Market Surveillance documentation.
Regulatory teams complete the GSPR Checklist.
If these documents are developed separately, inconsistencies quickly emerge.
Examples include:
- Different intended purpose statements
- Inconsistent device descriptions
- Different patient populations
- Conflicting performance claims
- Residual risks appearing in one document but not another
Although each document may appear acceptable on its own, the technical documentation should function as one integrated body of evidence.
Before submission, manufacturers should perform a comprehensive cross-document review to ensure terminology, claims and evidence remain consistent throughout the entire technical file.
4. Literature Reviews Cannot Be Reproduced
A robust literature review remains one of the strongest sources of clinical or performance evidence within technical documentation. Unfortunately, it is also one of the areas most frequently questioned during Notified Body reviews.
Many literature reviews contain extensive references but fail to demonstrate how those publications were identified, screened and selected. Without a transparent methodology, reviewers cannot determine whether the evidence has been selected objectively or whether important studies have been overlooked.
Common observations include:
- Missing database search strategies
- Incomplete Boolean search strings
- No documented search dates
- Undefined inclusion and exclusion criteria
- Missing justification for excluded studies
- Failure to follow a recognised methodology such as PRISMA
Notified Bodies increasingly expect literature reviews to be fully reproducible. A reviewer should be able to repeat the documented search strategy and achieve substantially the same results.
This level of transparency demonstrates scientific rigour and reduces concerns regarding selection bias.
Preparing a Clinical Evaluation Report?
A transparent literature review is one of the foundations of a compliant Clinical Evaluation Report (CER). Learn how to structure your CER, appraise clinical evidence and meet the latest EU MDR requirements by reading our Complete Guide to Clinical Evaluation Report (CER) Requirements.
5. Clinical Evidence Does Not Fully Support the Manufacturer's Conclusions
One of the most challenging aspects of technical documentation is demonstrating that the available evidence genuinely supports the manufacturer’s conclusions regarding safety and performance.
A large volume of published literature does not necessarily equate to strong clinical evidence.
Instead, reviewers assess whether the evidence:
- reflects the intended purpose of the device
- represents the target patient population
- addresses all significant safety concerns
- supports every clinical or performance claim
- remains current and scientifically relevant
For legacy devices, manufacturers sometimes continue relying heavily on historical evidence generated under the Medical Devices Directive (MDD). Under MDR, however, expectations have evolved considerably.
Notified Bodies increasingly expect manufacturers to supplement historical evidence with contemporary clinical data, Post-Market Clinical Follow-up (PMCF), Post-Market Performance Follow-up (PMPF) or robust post-market surveillance activities where appropriate.
The strength of a Clinical Evaluation lies not simply in the number of publications reviewed, but in the scientific justification connecting those publications to the safety and performance of the device under evaluation.
Keeping Up with the Latest Clinical Evaluation Guidance?
Clinical Evaluation expectations continue to evolve under the EU MDR. Discover how the latest MDCG guidance impacts clinical evidence, equivalence, PMCF and Clinical Evaluation Reports by reading our Guide to the Latest MDCG Clinical Evaluation Updates.
6. Risk Management Is Not Fully Integrated Throughout the Technical Documentation
Risk Management should never be viewed as a standalone activity completed simply to satisfy ISO 14971.
Instead, it should underpin almost every aspect of the technical documentation.
One of the most common observations raised during Notified Body reviews is incomplete traceability between the Risk Management File and other regulatory documents.
Examples include:
- Residual risks identified within the Risk Management File but not discussed within the Clinical Evaluation.
- Clinical complications identified during literature review but absent from the Risk Management File.
- Risk control measures that cannot be traced to verification or validation activities.
- Post-Market Surveillance activities that fail to monitor known residual risks.
Modern technical documentation should demonstrate complete bidirectional traceability.
Every identified hazard should be:
- assessed during risk analysis
- controlled through appropriate mitigation measures
- verified through testing
- evaluated clinically where applicable
- monitored throughout the product lifecycle
This integrated approach provides confidence that risks remain acceptable when weighed against the expected clinical benefits.
Need to Understand ISO 14971 Risk Management?
Effective risk management underpins every successful MDR and IVDR submission. Learn how ISO 14971 helps manufacturers identify hazards, evaluate risks, implement risk controls and maintain traceability throughout the entire medical device lifecycle by reading our Complete Guide to ISO 14971 Risk Management.
7. Post-Market Surveillance Is Too Passive
Post-Market Surveillance (PMS) has become one of the fastest evolving areas of MDR and IVDR compliance.
Historically, many manufacturers considered PMS to consist primarily of complaint handling and vigilance reporting.
Today, expectations are considerably higher.
Notified Bodies increasingly expect manufacturers to demonstrate proactive surveillance activities that continually confirm the safety and performance of their devices under normal clinical use.
Passive complaint collection alone rarely provides sufficient evidence.
Instead, robust PMS programmes often include:
- customer feedback programmes
- user questionnaires
- trend analysis
- complaint trending
- Post-Market Clinical Follow-up (PMCF)
- Post-Market Performance Follow-up (PMPF)
- registry data
- published literature monitoring
- periodic benefit-risk reviews
Equally important is demonstrating how the information collected feeds back into the Quality Management System.
For example, PMS findings should influence:
- Risk Management updates
- Clinical Evaluation updates
- Biological Evaluation reviews
- Design improvements
- CAPA activities
- Management Review
Notified Bodies increasingly assess whether manufacturers have established a continuous improvement process rather than simply collecting data for regulatory purposes.
Strong PMS demonstrates that compliance continues long after certification has been achieved.
Need to Understand Post-Market Surveillance?
Effective Post-Market Surveillance (PMS) is essential for demonstrating the ongoing safety, performance and benefit-risk acceptability of your medical device under the EU MDR and IVDR. Learn how to develop compliant PMS Plans, PMS Reports, PSURs and PMCF activities by reading our Complete Guide to Post-Market Surveillance for Medical Devices.
8. Administrative Inconsistencies Delay Technical Documentation Reviews
Not every Notified Body observation relates to complex clinical or scientific evidence. Some of the most avoidable delays arise from inconsistencies in administrative information throughout the technical documentation.
Although these issues may appear minor, they often raise questions regarding document control and quality management.
Examples frequently include:
- Different device names used throughout the technical file
- Inconsistent Basic UDI-DI information
- Outdated standards referenced within documentation
- Conflicting revision numbers between documents
- Mismatched intended purpose statements
- Inconsistent device variants or model numbers
- Expired certificates or declarations
- Labelling that differs from the Instructions for Use
These inconsistencies create unnecessary review comments and often require multiple rounds of clarification before the conformity assessment can progress.
A comprehensive document verification exercise before submission should confirm that every document within the technical file references the same device, intended purpose, applicable standards and revision status.
Maintaining robust document control procedures under an ISO 13485 Quality Management System can significantly reduce these avoidable deficiencies.
Want to Build an Audit-Ready Quality Management System?
Many technical documentation inconsistencies can be prevented with a well-implemented ISO 13485 Quality Management System. Discover how ISO 13485 supports document control, design controls, risk management, CAPA, internal audits and continual improvement by reading our Complete Guide to ISO 13485.
9. Biological Evaluation Lacks Scientific Justification
Biological Evaluation remains one of the most misunderstood elements of MDR technical documentation.
Many manufacturers assume compliance is demonstrated simply by obtaining biological test reports.
However, Notified Bodies increasingly assess the scientific rationale behind the overall Biological Evaluation strategy rather than focusing solely on laboratory testing.
Common observations include:
- Biological endpoints selected without documented justification.
- No Biological Evaluation Plan (BEP).
- Limited consideration of material characterisation.
- Toxicological risk assessments that do not address identified chemical constituents.
- Testing that is disproportionate to the nature and duration of patient contact.
- Failure to justify why certain biological endpoints were not evaluated.
The purpose of a Biological Evaluation is not to perform every available ISO 10993 test. Instead, manufacturers should adopt a risk-based approach that considers:
- Device materials
- Nature of body contact
- Duration of contact
- Existing clinical evidence
- Manufacturing processes
- Available toxicological information
- Chemical characterisation data
A well-structured Biological Evaluation Plan provides the scientific framework supporting this approach and helps demonstrate that biological safety has been evaluated proportionately.
This evidence should also remain aligned with the Risk Management File, Clinical Evaluation and Post-Market Surveillance activities to provide a consistent justification throughout the technical documentation.
Need to Understand Biological Evaluation?
Biological Evaluation is far more than selecting laboratory tests. Learn how to develop a risk-based Biological Evaluation, prepare compliant Biological Evaluation Plans (BEPs) and Biological Evaluation Reports (BERs), and demonstrate conformity with ISO 10993 by reading our Complete Guide to Biological Evaluation of Medical Devices.
10. Software Documentation Does Not Keep Pace with Software Development
As Software as a Medical Device (SaMD) continues to evolve, software lifecycle documentation has become an increasing focus during Notified Body reviews.
Unlike traditional hardware devices, software frequently undergoes updates to introduce new functionality, improve cybersecurity, resolve defects or enhance usability.
Each modification has the potential to affect the safety or performance of the device.
Common observations include:
- Software architecture documentation not reflecting the current software version.
- Missing software change impact assessments.
- Incomplete regression testing records.
- Poor traceability between software requirements and verification activities.
- Cybersecurity documentation that has not been updated following software changes.
- Risk Management documentation not reflecting software modifications.
Notified Bodies increasingly expect manufacturers to demonstrate robust software lifecycle management in accordance with IEC 62304.
Every software modification should be supported by documented change control, verification activities and an assessment of whether the update affects clinical performance, cybersecurity, usability or regulatory compliance.
As artificial intelligence, machine learning and connected medical devices become increasingly common, maintaining accurate software documentation throughout the product lifecycle will continue to grow in importance.
Developing Medical Device Software?
Software documentation is one of the most closely scrutinised areas during Notified Body reviews. Learn how IEC 62304 helps manufacturers develop compliant medical device software, manage software lifecycle processes, maintain traceability and demonstrate software safety by reading our Complete Guide to IEC 62304 Medical Device Software Development.
Preparing Your Technical Documentation Before Submission
Many of the observations discussed throughout this article can be identified long before technical documentation reaches a Notified Body.
A structured internal review helps identify inconsistencies while they remain straightforward to correct.
Before submitting your technical documentation, consider confirming that:
✓ Intended purpose is consistent throughout every document.
✓ Clinical and performance claims are supported by objective evidence.
✓ State of the Art has been clearly established.
✓ Literature reviews are transparent and reproducible.
✓ Risk Management is fully traceable to Clinical Evaluation and Biological Evaluation.
✓ Post-Market Surveillance activities monitor identified residual risks.
✓ Biological Evaluation has been developed using a documented scientific rationale.
✓ Software documentation reflects the current released version.
✓ Administrative information remains consistent across all documentation.
✓ All applicable standards and regulatory references are current.
Investing additional time before submission is almost always more efficient than responding to multiple rounds of regulatory questions after formal review has commenced.
Final Thoughts
Successfully navigating an MDR or IVDR conformity assessment is about far more than producing individual regulatory documents.
Notified Bodies evaluate whether the complete technical documentation provides a coherent, scientifically justified and fully traceable demonstration that the device is safe, performs as intended and complies with the applicable regulatory requirements.
Many of the deficiencies identified during technical documentation reviews are not caused by a lack of technical expertise. Instead, they result from inconsistencies between documents, incomplete scientific justification or insufficient traceability across the product lifecycle.
By addressing these common issues before submission, manufacturers can improve the quality of their technical documentation, reduce unnecessary review cycles and increase the likelihood of achieving certification without avoidable delays.
A proactive approach to technical documentation not only supports regulatory compliance but also strengthens the long-term safety, performance and lifecycle management of medical devices and IVDs.
Preparing for Notified Body Review?
Technical Documentation deficiencies are a common cause of questions, nonconformities and delays during conformity assessment. Learn how Notified Bodies assess medical devices under the EU MDR, review Technical Documentation and Quality Management Systems, conduct audits and issue CE certificates by reading our Complete Guide to Notified Bodies.
Need Support with Your MDR or IVDR Technical Documentation?
At Patient Guard, our regulatory consultants support manufacturers throughout every stage of the product lifecycle, including:
- MDR Technical Documentation
- IVDR Technical Documentation
- Clinical Evaluation Reports (CERs)
- Performance Evaluation Reports (PERs)
- Biological Evaluations
- Risk Management Files
- Post-Market Surveillance
- PMCF and PMPF
- ISO 13485 Quality Management Systems
- Software Documentation (IEC 62304)
- Gap Assessments and Pre-Submission Reviews
Whether you are preparing your first MDR or IVDR submission, updating legacy technical documentation or responding to Notified Body observations, our experienced team can help identify documentation gaps before they become costly certification delays.
Frequently Asked Questions
What are the most common deficiencies identified during MDR and IVDR Notified Body reviews?
Many deficiencies relate to inconsistencies within the technical documentation rather than missing documents. Common findings include inadequate Clinical Evaluation Reports, incomplete literature reviews, weak traceability between Risk Management and Clinical Evaluation, poorly justified Biological Evaluations, insufficient Post-Market Surveillance planning and inconsistencies between technical documentation, labelling and Instructions for Use.
How can manufacturers reduce the number of Notified Body observations?
Manufacturers can reduce review observations by carrying out a comprehensive internal technical documentation review before submission. This should verify that all regulatory documents are consistent, evidence supports every safety and performance claim, risk management is fully traceable and all administrative information matches throughout the technical file.
Can I change my EU Authorised Representative?
Yes. Manufacturers can transfer to a new EU Authorised Representative at any time, provided the existing mandate is formally terminated, a new Article 11 mandate is signed, EUDAMED records are updated where applicable, and product labelling is amended to display the new representative's details.
Why do Notified Bodies request additional information during technical documentation reviews?
Notified Bodies request additional information when they require further evidence to demonstrate compliance with the EU MDR or IVDR. Requests often arise where scientific justification is insufficient, documentation contains inconsistencies or the relationship between different parts of the technical file has not been clearly demonstrated.
Does receiving a Notified Body deficiency mean my device has failed certification?
No. Receiving review observations is a normal part of many conformity assessments. Manufacturers are typically given an opportunity to respond to the questions, provide additional evidence or update their technical documentation before the assessment progresses.
Why is traceability so important during a Notified Body review?
Traceability demonstrates that information is consistently linked throughout the technical documentation. For example, hazards identified within the Risk Management File should be evaluated within the Clinical Evaluation, monitored through Post-Market Surveillance and supported by verification or validation activities where appropriate.
How important are literature reviews during MDR and IVDR conformity assessments?
Literature reviews often form a significant part of the clinical or performance evidence supporting regulatory submissions. Notified Bodies expect literature searches to follow a transparent, reproducible methodology with clearly documented search strategies, inclusion criteria and scientific justification for the evidence selected.
What happens after responding to Notified Body review comments?
After reviewing the manufacturer's responses, the Notified Body may accept the evidence provided, request further clarification or raise additional questions if further justification is required. Once all observations have been satisfactorily addressed, the conformity assessment can progress towards certification.
Can Patient Guard review our technical documentation before submission?
Yes. Patient Guard provides independent technical documentation reviews to help manufacturers identify gaps before submission to a Notified Body. Our consultants can assess Clinical Evaluations, Performance Evaluations, Biological Evaluations, Risk Management Files, Post-Market Surveillance documentation and complete MDR or IVDR technical files to help reduce the likelihood of avoidable review observations.
References
This guide is based on the EU Medical Device Regulation (MDR), EU In Vitro Diagnostic Medical Device Regulation (IVDR), European Commission guidance and Medical Device Coordination Group (MDCG) guidance relating to Technical Documentation, Clinical Evaluation, clinical evidence, Post-Market Clinical Follow-up and Notified Body conformity assessment.
| Organisation | Reference | Why it's relevant |
|---|---|---|
| European Union | Regulation (EU) 2017/745 – Medical Device Regulation (MDR) | Establishes the regulatory requirements for medical devices in the European Union. Article 10 requires manufacturers to prepare and maintain Technical Documentation, while Annexes II and III define the required content for Technical Documentation and Post-Market Surveillance documentation. Annexes I, IX and XIV also contain key requirements relating to GSPRs, conformity assessment, Clinical Evaluation and PMCF. |
| European Union | Regulation (EU) 2017/746 – In Vitro Diagnostic Medical Device Regulation (IVDR) | Establishes the corresponding regulatory framework for in vitro diagnostic medical devices. It sets requirements for Technical Documentation, Performance Evaluation, risk management, Post-Market Surveillance and conformity assessment, all of which may be examined during an IVDR Notified Body review. |
| European Commission / MDCG | MDCG 2020-13 – Clinical Evaluation Assessment Report Template | Provides a structured framework used to support Notified Body assessment of Clinical Evaluations under the MDR. It provides useful insight into the areas reviewers examine, including clinical evidence, State of the Art, benefit-risk conclusions, equivalence, PMCF and consistency between the Clinical Evaluation and other Technical Documentation. |
| European Commission / MDCG | MDCG 2020-5 – Guidance on Clinical Evaluation: Equivalence | Provides guidance on demonstrating equivalence under the MDR, including the technical, biological and clinical characteristics that must be considered. It is particularly relevant where a Clinical Evaluation relies on data from an equivalent device and where inadequate equivalence justification may lead to Notified Body observations. |
| European Commission / MDCG | MDCG 2020-6 – Guidance on Sufficient Clinical Evidence for Legacy Devices | Provides guidance on the level of clinical evidence expected for legacy medical devices under the MDR. It is particularly relevant when determining whether historical clinical data remains sufficient and whether additional clinical evidence, PMCF or other post-market activities may be necessary. |
| European Commission / MDCG | MDCG 2020-7 – Post-Market Clinical Follow-up (PMCF) Plan Template | Provides guidance on preparing a structured PMCF Plan in accordance with the MDR. PMCF should be linked to Clinical Evaluation, risk management and Post-Market Surveillance, making consistency between these documents an important consideration during Technical Documentation review. |
| European Commission / MDCG | MDCG 2020-8 – Post-Market Clinical Follow-up Evaluation Report Template | Provides guidance for documenting and evaluating the results of PMCF activities. The conclusions of PMCF should feed back into the Clinical Evaluation, risk management documentation and Post-Market Surveillance system, making effective traceability between these documents important during conformity assessment. |
| European Commission | MEDDEV 2.7/1 Revision 4 – Clinical Evaluation: A Guide for Manufacturers and Notified Bodies | Provides detailed guidance on the planning, identification, appraisal and analysis of clinical data and preparation of Clinical Evaluation Reports. It also addresses literature searching, State of the Art, risk-benefit assessment and the relationship between Clinical Evaluation, risk management and Post-Market Surveillance. |
| European Commission / MDCG | MDCG Guidance Documents – Medical Devices and IVDs | Provides the European Commission's current collection of MDCG guidance supporting implementation of the MDR and IVDR. Manufacturers should review applicable guidance when preparing or updating Technical Documentation because regulatory expectations and guidance continue to develop. |
Technical Documentation should be maintained as a coherent and continuously updated body of evidence throughout the device lifecycle. Manufacturers should ensure that current versions of applicable regulations, MDCG guidance, harmonised standards and Common Specifications are considered when preparing documentation for Notified Body review.
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