Lumiform
Features Solutions Resources Templates Enterprise Pricing
Select a language
Englishen
Deutschde
Françaisfr
Españoles
Português (BR)pt-BR
en
Contact salesLog in
Sign up
Back
Englishen
Deutschde
Françaisfr
Españoles
Português (BR)pt-BR
Features Solutions Resources Templates Enterprise Pricing
Free demo
Log in
en
Book a personal demoView video demoContact sales
Explore
Resource hubCentral repository for all Lumiform resourcesCustomer storiesReal-world successes and experiences with Lumiform.
Learn
Template collectionsComprehensive collections of best practice templates.Topic guidesComprehensive safety, quality, and excellence insights.LexiconDefinitions key to quality, safety, and compliance.
Support
Developer's guideTechnical documentation for developers.Help centerAssistance with onboarding and platform mastery.
Featured reads
Explore our collection of 38 free preventive maintenance checklists

Template collection

Explore our collection of 38 free preventive maintenance checklists

Start reading
Your guide to performing and documenting efficient child care observation

Topic guide

Your guide to performing and documenting efficient child care observation

Start reading
Lumiform as customer journey mapping tool in gastronomy

Success story

Lumiform as customer journey mapping tool in gastronomy

Start reading
Book a personal demoView video demoContact sales
By industry
Food and hospitalityManufacturingConstructionRetailTransport and logisticsFacility managementView all industries
By business needs
Health and safety managementQuality managementOperational excellenceRisk management and complianceView all business needs
By use case
Safety management softwareEnergy audit appForklift inspection appBuilding management softwareVehicle inspection appQMS appKaizen method appProperty inspection appRestaurant inspection appElevator management appProject management softwareFire inspection app
View all app uses
Book a personal demoView video demoContact sales
Overview
Template libraryDiscover over 12,000 free, ready-made and expert proofed templates.
Use cases
CleaningMaintenanceRisk assessmentSupply chainIncident management
Business needs
Health and safety managementQuality managementOperational excellenceRisk management and compliance
Industries
Food and hospitalityManufacturingRetailTransport and logisticsConstructionFacility management
Book a personal demoView video demoContact sales
Overview
Product overviewAll features
Capabilities
Digitize
Form builderMobile AppActions
Automate
Workflow automationApprovalsIntegrations
Transparency and accountability
ReportsAnalytics
Orchestrate
Administration
Book a personal demoView video demoContact sales
Templates
EU MDR gap analysis template

EU MDR gap analysis template

Conduct a thorough gap analysis with the EU MDR gap analysis template. Identify compliance gaps, assess current processes, and develop strategies to meet regulatory requirements effectively.

Use this template
or download pdf
EU MDR gap analysis template

Conduct a thorough gap analysis with the EU MDR gap analysis template. Identify compliance gaps, assess current processes, and develop strategies to meet regulatory requirements effectively.

Use this template
or download pdf

About the EU MDR gap analysis template

Using an EU MDR gap analysis template is crucial for identifying compliance gaps in your medical device processes. This template helps you systematically compare current practices against EU MDR requirements, ensuring no critical elements are overlooked. By using this tool, you can efficiently pinpoint areas needing improvement.

A checklist such as the EU MDR gap analysis serves you by providing a clear framework to assess compliance readiness. It helps prioritize actions, ensuring resources are allocated effectively to address deficiencies. This structured approach not only saves time but also enhances your compliance strategy, reducing the risk of regulatory penalties.

By leveraging this EU MDR template, you can optimize your workflow, streamline compliance efforts, and ensure your medical devices meet all necessary standards for market approval. This proactive measure strengthens your product’s credibility and safety in the European market.

Key elements of an EU MDR gap analysis template

Understanding the key elements of this gap analysis template is essential for achieving compliance. This template includes several crucial components that guide you through a thorough evaluation.

  • Regulatory requirements checklist: This section outlines the specific EU MDR standards your processes must meet. By systematically checking each requirement, you ensure that no critical element is missed.
  • Current practices assessment: Here, you document your existing processes and compare them to regulatory standards. This helps you identify discrepancies and areas needing improvement.
  • Gap identification: This component focuses on pinpointing specific compliance gaps. By clearly highlighting these areas, you can prioritize actions and allocate resources effectively.
  • Action plan development: This section guides you in creating a strategic plan to address identified gaps. It ensures that all necessary steps are taken to achieve full compliance.

Customizing your EU MDR gap analysis template

To make the most of an EU MDR gap analysis template, you can tailor it to fit your organization’s specific needs. Start by adapting the regulatory requirements checklist to focus on the standards most relevant to your products. This ensures you address the most critical compliance areas efficiently.

You can also customize the current practices assessment section by including specific processes unique to your organization. This allows for a more accurate comparison and identification of gaps.

Finally, modify the action plan development section to align with your organizational structure. Assign responsibilities and set realistic timelines to ensure effective implementation. By customizing these elements, you optimize the template to better serve your compliance strategy, enhancing both efficiency and effectiveness in achieving regulatory goals.

Related categories

  • Risk management and compliance templates
  • Health care templates
  • Templates for manufacturing processes
Preview of the template
Regulatory Requirements
Has your organization identified all applicable requirements of the EU MDR?
Have you documented the EU MDR requirements that apply to your organization?
Have you assigned responsibilities for addressing each EU MDR requirement?
Current Compliance Status
Have you assessed your organization's current state of compliance with the EU MDR?
Have you identified gaps between your current practices and the EU MDR requirements?
Have you prioritized the identified compliance gaps based on risk and urgency?
Action Plans
Have you developed action plans to address the identified compliance gaps?
Have you assigned responsibilities and deadlines for executing the action plans?
Have you implemented a process to monitor the progress of your action plans?

More templates like this

EU MDR Checklist
EU MDR Checklist
The EU MDR checklist is designed to help your team systematically manage compliance with the European Medical Device Regulation.
Templates for manufacturing processes
EU MR Documents Template
EU MR Documents Template
Follow the quality and safety requirements of the EU MDR with this free EU MDR Must-Have Documents Template, and feel confident that you and your team followed all mandatory protocol.
Templates for manufacturing processes
EU MDR Clinical Evaluation Report
EU MDR Clinical Evaluation Report
The EU MDR clinical evaluation report template provides a framework for documenting clinical data and evaluations.
Templates for manufacturing processes
GMP Audit Checklist For Pharma
GMP Audit Checklist For Pharma
Ensure compliance with Good Manufacturing Practices (GMP) in the pharmaceutical industry using this checklist. It covers quality control, documentation, and facility standards.
Quality assurance templates
Pharmaceutical process validation protocol template
Pharmaceutical process validation protocol template
Tailored for the pharmaceutical industry, this template ensures that each stage of your drug manufacturing process meets regulatory standards.
Quality assurance templates
Pharmaceutical due diligence checklist
Pharmaceutical due diligence checklist
Streamline pharmaceutical acquisitions with this checklist, focusing on regulatory compliance, financial evaluations, and market assessments.
Risk assessment templates

Related resources

Access a complete set of resources aimed at maximizing safety, quality, and operational excellence, including detailed guides, related templates, and real-world use cases.

Topic guides

Read in-depth guides covering key topics related to this article.

Navigating medical device regulations: Key steps for compliance A beginner’s guide HIPAA polices and proceduresInfection control guide: Best practices and strategiesCE Marking: Guide to European Conformity CertificateGap analysis: A complete guide with tools for strategic improvement
See all topic guides

Template collections

See comprehensive collections of best practice templates related to this topic.

Top 4 EU MDR checklist templates for complianceTop 6 free ISO 45001 audit checklist templates6 free contact tracing forms45 free risk assessment templates for every industry 10 powerful free health and safety policy templates
See all template collections

Use cases

Check out how the Lumiform software can be utilized for related use cases.

Apply Lumiform's workflow automation platform to all use casesSafety Management SoftwareRisk assessment softwareCompliance audit softwareConduct inspections with Lumiform's customizable workflow software
See all use cases

Other resources

Explore all the additional resources we offer to assist you in mastering this topic.

4 types of gap analysisHow to evaluate compliance measures5 ways workflow automation streamlines healthcare administrationThe New Normal: A Look at the World Three Years Post-COVID

Frequently asked questions

What is an EU MDR gap analysis template and why is it important?

An EU MDR gap analysis template helps you identify compliance gaps in your medical device processes. It’s crucial for ensuring all regulatory requirements are met, reducing the risk of non-compliance and enhancing your product’s safety and market readiness.

How can I effectively conduct a gap analysis for EU MDR compliance?

To conduct an effective gap analysis, compare your current practices with EU MDR standards, identify discrepancies, and develop a strategic action plan. Regular reviews and updates ensure you address all compliance areas effectively, minimizing risks and enhancing efficiency.

What common challenges do companies face with EU MDR compliance?

Companies often struggle with complex documentation, frequent regulatory updates, and resource constraints. Overcoming these challenges requires staying informed, investing in training, and utilizing structured templates to streamline compliance


This template, developed by Lumiform employees, serves as a starting point for businesses using the Lumiform platform and is intended as a hypothetical example only. It does not replace professional advice. Companies should consult qualified professionals to assess the suitability and legality of using this template in their specific workplace or jurisdiction. Lumiform is not liable for any errors or omissions in this template or for any actions taken based on its content.
Lumiform logo
Platform
HomeSign upProductAll featuresPricingEnterpriseTrust and securityCustomer success offeringsDownload the app
Solutions
IndustriesFood and hospitalityManufacturingConstructionRetailTransport and logisticsFacility management
Business needsHealth and safety managementQuality managementOperational excellenceCompliance and risk management
Uses cases
Learn
Template collectionsTopic guidesLexiconHelp centerJournalInfographicsVideos
Resources
Lumiform templatesby industryby use caseby business needAll categories
Customer storiesDeveloper APIResource hubIntegrations
Company
AboutJobsLegalBook a demoContact sales
© 2025 LumiformTerms and conditionsPrivacyData processingSitemap
App StoreGoogle play