EU MDR 2017/745 Gap Assessment, Technical Documentation Review, GSPR Mapping, Clinical Evidence Review & CE Marking Readiness Support

Planning to place your medical device on the European Union market? Already CE marked under MDD and now need EU MDR readiness? Preparing for Notified Body review, technical documentation submission, surveillance audit, or CE marking renewal?

Easy Compliance helps medical device manufacturers, exporters, startups, OEMs, private label brands, contract manufacturers, SaMD developers, diagnostic equipment suppliers, hospital equipment companies, and regulatory teams perform a complete EU MDR Gap Analysis against Regulation (EU) 2017/745.

With 24 years of experience, our team supports companies with MDR gap assessment, technical documentation review, GSPR checklist review, device classification review, clinical evaluation gap assessment, PMS / PMCF review, risk management file review, ISO 13485 QMS alignment, labelling and IFU review, UDI readiness, Notified Body preparation, MDR transition support, gap remediation planning, and CE marking readiness.

Easy Compliance – Simplify Compliance. Secure Growth.

What is MDR Gap Analysis?

An MDR Gap Analysis is a structured assessment of your medical device documentation, quality system, regulatory strategy, clinical evidence, risk file, labelling, PMS, and CE marking readiness against the requirements of EU MDR 2017/745.

In simple words:

MDR Gap Analysis = Checking what you already have, comparing it with EU MDR expectations, finding what is missing, and creating a clear action plan to become MDR-ready.

The purpose is to identify:

• Missing documents
• Weak evidence
• Outdated MDD-era files
• Incorrect classification
• Incomplete GSPR mapping
• Weak clinical evaluation
• Missing PMCF justification
• PMS gaps
• Risk management gaps
• Labelling and IFU issues
• UDI readiness gaps
• QMS process gaps
• Notified Body readiness issues

A good MDR gap analysis gives your team a practical roadmap instead of confusion.

Why MDR Gap Analysis Matters

EU MDR introduced stronger expectations for medical device safety, performance, clinical evidence, post-market surveillance, traceability, technical documentation, and lifecycle compliance.

Many companies still have documents created under the old Medical Device Directive structure. These files may not be enough for MDR technical documentation or Notified Body review.

A proper MDR gap analysis helps your company:

• Understand your actual MDR readiness level
• Identify missing or weak technical documentation
• Prepare for CE marking under EU MDR
• Reduce Notified Body findings
• Avoid delays during technical file review
• Improve GSPR evidence mapping
• Strengthen clinical evaluation and PMCF planning
• Improve PMS and vigilance readiness
• Update risk management and benefit-risk documentation
• Confirm device classification under MDR Annex VIII
• Align QMS processes with MDR expectations
• Plan remediation work by priority and risk
• Support smoother EU market access

MDR gap analysis is especially useful before submitting a technical file, starting Notified Body review, renewing certification, launching a new device, or transitioning legacy devices from MDD to MDR.

Who Needs MDR Gap Analysis?

You may need MDR gap analysis if you are:

• A medical device manufacturer targeting the EU market
• A company transitioning from MDD to MDR
• A manufacturer with legacy CE-marked devices
• A startup preparing first CE marking submission
• A private label medical device brand
• An OEM or contract manufacturer
• A SaMD or digital health company
• A company preparing Notified Body submission
• A company facing Notified Body questions
• A company updating technical documentation
• A company preparing MDR surveillance audit
• A company with outdated CER, PMS, PMCF, risk or GSPR documents
• A company planning EU, UK, USA, India, Canada, Australia, or Saudi Arabia market expansion

If you are unsure whether your file is MDR-ready, a gap analysis is the safest first step.

Easy Compliance MDR Gap Analysis Service Portfolio

1. MDR Regulatory Strategy Review

We start by reviewing your current regulatory strategy and market access plan.

Our review includes:

• Device intended purpose
• Current CE status
• MDD to MDR transition status
• Device class and classification rationale
• Conformity assessment route
• Notified Body requirement
• Applicable MDR annexes
• EC REP requirement
• UDI and EUDAMED readiness
• Technical documentation readiness
• Clinical evidence strategy
• PMS and PMCF strategy
• QMS readiness
• Market and distribution status

We help determine whether your current strategy supports MDR compliance or needs correction.

2. Device Classification Gap Analysis

Device classification under MDR can differ from older MDD assumptions. Incorrect classification can create major compliance and submission issues.

Easy Compliance reviews classification based on:

• Intended purpose
• Duration of use
• Invasiveness
• Active or non-active function
• Implantable status
• Measuring function
• Sterile status
• Reusable surgical instrument status
• Software function
• Diagnostic or therapeutic purpose
• MDR Annex VIII classification rules
• Borderline or accessory status

We identify whether the device classification is justified, documented, and aligned with MDR expectations.

3. Technical Documentation Gap Analysis

Technical documentation is the core evidence package for MDR compliance.

Easy Compliance reviews your technical file against MDR expectations, including:

• Device description
• Product variants and accessories
• Intended purpose
• Manufacturer information
• Design and manufacturing information
• GSPR checklist
• Risk management file
• Benefit-risk analysis
• Verification and validation evidence
• Clinical evaluation documentation
• PMS documentation
• PMCF documentation
• Labels and IFU
• UDI information
• Declaration of Conformity
• Standards list
• Test reports
• Software documentation, where applicable
• Cybersecurity documentation, where applicable
• Usability documentation, where applicable
• Sterilization and packaging evidence, where applicable
• Biological safety evidence, where applicable
• Electrical safety and EMC evidence, where applicable

We identify missing, weak, outdated, inconsistent, or poorly linked documents.

4. GSPR Checklist Gap Analysis

The General Safety and Performance Requirements, commonly called GSPR, are central to MDR technical documentation.

Easy Compliance reviews your GSPR checklist for:

• Applicable and non-applicable requirement justification
• Evidence mapping
• Standards linkage
• Risk management linkage
• Clinical evidence linkage
• V&V evidence linkage
• PMS and PMCF linkage
• Labelling and IFU linkage
• Software and cybersecurity evidence linkage
• Missing evidence
• Weak rationales
• Notified Body review readiness

A strong GSPR checklist should show exactly how your device meets MDR safety and performance requirements.

5. Clinical Evaluation Report Gap Analysis

Clinical Evaluation Report, or CER, is one of the most important MDR documents.

Easy Compliance reviews:

• Clinical Evaluation Plan
• CER structure
• Intended purpose and claims
• Clinical benefit definition
• Literature search methodology
• State-of-the-art review
• Clinical data appraisal
• Equivalence justification, where used
• Access to equivalent device data, where applicable
• PMS and PMCF data integration
• Benefit-risk conclusion
• GSPR linkage
• Risk management linkage
• CER update frequency
• Evaluator qualifications
• Notified Body readiness

We identify whether the CER is strong enough to support MDR conformity.

6. PMCF Gap Analysis

Post-Market Clinical Follow-up, or PMCF, is a major area of MDR scrutiny.

Easy Compliance reviews:

• PMCF applicability
• PMCF justification
• PMCF plan
• PMCF activities
• PMCF survey or study approach
• PMCF Evaluation Report
• PMCF linkage with CER
• PMCF linkage with PMS
• PMCF linkage with risk management
• Data collection methods
• Timelines and responsibilities
• Open clinical data gaps

We help determine whether your PMCF strategy is adequate or needs strengthening.

7. PMS and Vigilance Gap Analysis

Post-market surveillance is a lifecycle requirement under MDR.

Easy Compliance reviews:

• PMS plan
• PMS report
• PSUR, where applicable
• Complaint handling process
• Trend reporting process
• Vigilance procedure
• Serious incident handling
• Field Safety Corrective Action process
• Field Safety Notice process
• Distributor feedback process
• PMS data sources
• PMS indicators and thresholds
• PMS linkage with CER, PMCF, risk management, CAPA, and technical documentation

We help ensure your post-market system is active, documented, and connected to product risk.

8. Risk Management File Gap Analysis

Risk management must be connected with design, clinical evidence, PMS, labelling, and technical documentation.

Easy Compliance reviews:

• Risk management plan
• Hazard identification
• Risk analysis
• Risk evaluation
• Risk control measures
• Risk control verification
• Residual risk evaluation
• Overall residual risk review
• Benefit-risk analysis
• Production and post-production monitoring
• Risk linkage with GSPR
• Risk linkage with CER
• Risk linkage with PMS and PMCF
• Risk linkage with labelling and IFU
• Risk management report

We help identify whether your ISO 14971 risk file can support MDR expectations.

9. Verification and Validation Evidence Gap Analysis

MDR technical documentation must include suitable evidence to support safety and performance.

Easy Compliance reviews V&V evidence such as:

• Bench testing
• Performance testing
• Software verification and validation
• Electrical safety testing
• EMC testing
• Biocompatibility testing
• Sterilization validation
• Packaging validation
• Shelf-life evidence
• Cleaning and reprocessing validation
• Usability engineering evidence
• Clinical or performance evidence
• Test report traceability
• Acceptance criteria
• Deviations and justifications
• Standards compliance

We help identify missing tests, outdated reports, weak acceptance criteria, and poor traceability.

10. Labelling, IFU and Claims Gap Analysis

Labelling and Instructions for Use must be consistent with the intended purpose, risk file, clinical evidence, and MDR requirements.

Easy Compliance reviews:

• Product labels
• Packaging artwork
• Instructions for Use
• Intended purpose wording
• Indications and contraindications
• Warnings and precautions
• Symbols
• Manufacturer and EC REP information
• UDI information
• Storage and transport conditions
• Sterile or single-use claims
• Marketing claims
• Website and brochure claims
• Consistency with CER and risk file

We help identify claims or wording that may create MDR review issues.

11. UDI and EUDAMED Readiness Gap Analysis

MDR requires strong traceability and device identification planning.

Easy Compliance reviews:

• Basic UDI-DI readiness
• UDI-DI readiness
• Production identifier requirements
• Device variant mapping
• Labelling impact
• Database information preparation
• Economic operator information
• EUDAMED data readiness
• Internal traceability processes

We help organize device identification and traceability before market placement.

12. ISO 13485 QMS and MDR Process Gap Analysis

Technical documentation alone is not enough. MDR also requires quality system processes that support regulatory compliance.

Easy Compliance reviews QMS processes such as:

• Document control
• Record control
• Design control
• Risk management
• Supplier control
• Production control
• Complaint handling
• CAPA
• Change control
• PMS
• PMCF
• Vigilance
• Regulatory change monitoring
• Economic operator control
• Internal audits
• Management review
• Training records
• Clinical evaluation process
• Technical documentation maintenance process

We help align ISO 13485 processes with MDR requirements.

13. SaMD and Software MDR Gap Analysis

Software medical devices face special MDR challenges, including classification, cybersecurity, software lifecycle evidence, and post-market monitoring.

Easy Compliance reviews:

• SaMD qualification
• MDR Rule 11 classification
• Software intended purpose
• Software requirements
• Software architecture
• Software verification and validation
• Software release records
• Version control
• Cybersecurity risk management
• Data protection and access control evidence
• Usability evidence
• Algorithm change control
• Software PMS
• Technical file linkage

We help software teams identify MDR gaps before submission.

14. Notified Body Readiness Review

Before submission, it is important to know whether your file is ready for Notified Body review.

Easy Compliance checks:

• Technical documentation completeness
• File structure and indexing
• Cross-document consistency
• Open gaps and risk level
• Critical missing evidence
• Likely Notified Body questions
• Submission readiness status
• Priority remediation actions
• Timelines and resource needs

We help your team submit with more confidence.

Our MDR Gap Analysis Process

Step 1: Product and File Intake

We collect product information, intended purpose, current CE status, device class, technical documentation, QMS documents, clinical evidence, risk file, PMS documents, labels, IFU, and existing certificates.

Step 2: MDR Applicability and Scope Review

We define the gap analysis scope based on device type, classification, conformity route, and current readiness level.

Step 3: Requirement-by-Requirement Review

We review your documentation against MDR expectations, relevant annexes, GSPR, technical documentation requirements, PMS requirements, clinical requirements, and QMS process needs.

Step 4: Gap Identification

We identify missing documents, weak evidence, inconsistent claims, outdated files, unlinked evidence, and high-risk compliance gaps.

Step 5: Gap Severity Rating

We classify gaps based on risk and impact:

• Critical gaps
• Major gaps
• Minor gaps
• Improvement opportunities

Step 6: Remediation Roadmap

We create a clear action plan showing what needs to be corrected, why it matters, priority level, owner, estimated effort, and recommended next step.

Step 7: Remediation Support

We support documentation updates, GSPR mapping, CER updates, PMS/PMCF improvements, risk file updates, labelling corrections, QMS process updates, and technical file restructuring.

Step 8: Final Readiness Review

After remediation, we review the updated file and provide readiness feedback for Notified Body, CE marking, or internal compliance purposes.

MDR Gap Analysis Deliverables

Depending on the project scope, Easy Compliance can provide:

• MDR gap analysis report
• Technical documentation checklist
• GSPR gap matrix
• Clinical evaluation gap report
• PMS / PMCF gap report
• Risk management gap report
• Labelling and IFU review comments
• UDI readiness checklist
• QMS process gap report
• SaMD / software documentation gap report
• Notified Body readiness summary
• Remediation action plan
• Priority-based compliance roadmap
• Management summary for leadership

Common MDR Gaps We Find

Many companies face MDR readiness problems such as:

• MDD technical file not upgraded for MDR
• Incorrect device classification
• Weak classification rationale
• Incomplete GSPR checklist
• Missing evidence for GSPR requirements
• Outdated CER
• Weak clinical benefit definition
• Poor state-of-the-art review
• Weak equivalence strategy
• Missing PMCF plan
• Incomplete PMS plan
• Missing PSUR, where required
• Risk file not aligned with MDR
• Risk controls not linked to evidence
• Missing benefit-risk analysis
• Labelling claims not supported by clinical evidence
• Missing UDI planning
• Software documentation gaps
• Cybersecurity evidence gaps
• QMS processes not updated for MDR
• Weak technical file structure
• Inconsistent information across documents

Easy Compliance helps convert these gaps into a structured remediation plan.

Why Choose Easy Compliance?

24 Years of Experience

Our experience helps medical device companies identify MDR gaps quickly and build practical remediation plans.

Complete MDR Coverage

We review technical documentation, clinical evaluation, risk management, PMS, PMCF, GSPR, labelling, UDI, QMS processes, SaMD documentation, and Notified Body readiness.

Practical Gap Reports

We do not only list problems. We explain what the gap is, why it matters, how serious it is, and how to fix it.

Strong MDR Evidence Mapping

We connect GSPR, CER, risk management, PMS, PMCF, V&V, labelling, and QMS evidence.

Support for Legacy and New Devices

We support both MDD-to-MDR transition files and new MDR technical documentation.

Remediation Support

After identifying gaps, we can help update and strengthen the documents needed for MDR readiness.

Easy Compliance MDR Gap Analysis Advantage

MDR Technical File Review

We assess whether your technical documentation is complete, structured, and submission-ready.

GSPR Evidence Mapping

We identify missing or weak evidence against applicable GSPR requirements.

CER, PMS and PMCF Review

We check whether clinical and post-market documents support MDR expectations.

Risk Management File Review

We review risk documentation and its connection with design, clinical evidence, PMS, labelling, and GSPR.

SaMD and Cybersecurity Gap Review

We support software medical device documentation, Rule 11 classification, validation, cybersecurity, and lifecycle monitoring.

QMS Process Review

We assess whether your ISO 13485 QMS processes support MDR lifecycle compliance.

Notified Body Readiness

We help identify likely review questions before submission.

Actionable Remediation Roadmap

We provide clear next steps, priority levels, and practical correction guidance.

Related Services

You may also be interested in:

CE Marking Consulting

EU MDR / IVDR compliance, technical documentation, GSPR, Notified Body support, EC REP coordination, and EU market access.

Clinical Evaluation Report Consulting

CER, Clinical Evaluation Plan, literature review, state-of-the-art, PMCF, GSPR linkage, and Notified Body readiness.

Risk Analysis and ISO 14971 Support

Risk management file, hazard analysis, FMEA, benefit-risk analysis, PMS linkage, and ISO 14971 documentation.

Medical Device QMS Consulting

ISO 13485, FDA QMSR, MDSAP, eQMS, CAPA, audit readiness, and quality system implementation.

Design History File Consulting

DHF, design controls, V&V records, traceability matrix, design transfer, and design change control.

SaMD Regulatory Support

Software medical device classification, technical documentation, cybersecurity, validation, risk and PMS readiness.

UKCA and MHRA Support

UK MDR 2002 compliance, UKCA marking, MHRA registration, UKRP coordination, and Great Britain market access.

Global Medical Device Market Access

Regulatory planning for EU, UK, USA, India, Canada, Australia, Saudi Arabia, UAE, and other markets.

Frequently Asked Questions

What is MDR Gap Analysis?

MDR Gap Analysis is a structured review of your medical device documentation, QMS processes, regulatory strategy, clinical evidence, risk file, PMS, labelling, and technical file against EU MDR 2017/745 requirements.

Who needs MDR Gap Analysis?

Manufacturers preparing CE marking, transitioning from MDD to MDR, responding to Notified Body questions, updating technical files, or planning EU market entry should consider MDR gap analysis.

What documents are reviewed in MDR Gap Analysis?

Common documents include technical file, GSPR checklist, CER, PMS plan, PMCF plan, risk management file, labels, IFU, V&V evidence, UDI plan, QMS procedures, software documentation, and Declaration of Conformity.

Is MDR Gap Analysis required by law?

MDR gap analysis itself is not a separate legal certificate. It is a practical compliance assessment used to identify and correct gaps before submission, audit, or market entry.

What is the difference between MDD and MDR gap analysis?

MDD-to-MDR gap analysis checks whether legacy documentation created under the older directive is updated to meet stronger MDR expectations, including clinical evidence, PMS, PMCF, GSPR, UDI, and lifecycle requirements.

Can Easy Compliance help after identifying gaps?

Yes. Easy Compliance can help with remediation, including CER updates, GSPR mapping, PMS/PMCF documents, risk file updates, QMS process updates, labelling review, and technical file restructuring.

Does MDR Gap Analysis include CER review?

Yes. CER review is one of the most important parts of MDR gap analysis because clinical evidence is heavily reviewed under MDR.

Does MDR Gap Analysis include SaMD?

Yes. Easy Compliance supports MDR gap analysis for SaMD and software medical devices, including Rule 11 classification, software lifecycle evidence, cybersecurity, validation, risk and PMS linkage.

Can MDR Gap Analysis reduce Notified Body findings?

It can help reduce avoidable findings by identifying weak evidence, missing documents, inconsistent claims, and technical file problems before Notified Body submission.

How can Easy Compliance help?

Easy Compliance helps review your MDR readiness, identify gaps, prioritize remediation, update documentation, strengthen evidence mapping, and prepare your file for CE marking or Notified Body review.

Need MDR Gap Analysis for Your Medical Device?

If you are preparing for CE marking, transitioning from MDD to MDR, updating your technical file, responding to Notified Body questions, or checking whether your documentation is MDR-ready, Easy Compliance can help.

Talk to our MDR Gap Analysis experts and get a clear action plan for your next step.

Contact Easy Compliance

Call: 9877194003
Email: ecomplaince@gmail.com
Email: info@easycomplaince.com
Website: https://easycomplaince.com/

Easy Compliance
Simplify Compliance. Secure Growth.