...
+91-7490017774 (For Enquiry Only) +91-7490017774 (For Enquiry Only) +91 9429952147 (For Career Only)
enquiry@mavenprofserv.com
Maven
Template
Gap Analysis

Gap Analysis

  2. Services
  3. CE Certification Consultancy
  4. MDD Vs MDR - Gap Analysis

A gap analysis is a helpful tool that helps you figure out where you are right now, where you want to go, and how to get there. It is often used at the start of the certification process to compare what is already in place with the requirements that need to be met for certification.

This analysis can be applied to various regulatory and quality management system documentation, such as:

  • IVDD vs IVDR gap analysis: to be performed while transitioning from the IVD directive to IVDR regulation
  • IVDR gap analysis: Get your IVDR submissions reviewed before the notified body submission
  • MDD to MDR gap analysis: to be performed while transitioning from the MD directive to the EU MDR regulation
  • EU MDR gap analysis: Check the compliance of your EU MDR documentation to be in line with the notified body's expectations.
  • Quality Management System (QMS) gap assessment: It can include reviewing your existing QMS for its adequacy or integrating the requirements of other QMS standards like 21 CFR Part 820 or MDSAP
  • New product or testing standard gap analysis: Whether you need to re-perform product testing or prepare justifications, or comply with additional requirements can be decided based on gap analysis.

In general, by performing a gap analysis, you can identify areas that need improvement and create a plan to meet the necessary standards for certification.

Gap-Analysis-is-a-strategic-planning-tool

Gap analysis for MDD to EU-MDR:

Gap-analysis-for-MDD-to-EU-MDR

The EU-MDR (Medical Device Regulation) was introduced in April 2017 to ensure higher levels of patient and user safety. This regulation sets strict standards for demonstrating the quality and safety of medical devices.

If you’re currently certified under the MDD (Medical Device Directive) 93/42/EEC, your certification will soon expire. It’s smart to start planning your transition to EU-MDR now to avoid delays due to Notified Body backlogs or availability issues.

A thorough MDD vs MDR Gap Analysis is the first step. It helps identify where your current documentation, processes, and quality system fall short of MDR requirements—so you know exactly what needs to be updated.

If you’re unsure where to begin, Maven can help.

We offer thorough gap analysis services to review your technical documentation, processes, and Quality Management System (QMS), helping you navigate the shift to EU-MDR. Our expert gap analysis includes a review of:

  • Technical files and design documents
  • Product classification
  • Clinical evaluation reports
  • Risk management reports
  • Instructions for Use (IFU) and labels
  • Post-market surveillance (protocols, plans, and reports)
  • European Authorised Representative (EC REP) agreements
  • Supplier and distributor documents (agreements and procedures)
  • Product testing (both internal and external)
  • Vigilance procedures

We help you streamline the transition from MDD to MDR and ensure you’re fully compliant with the latest regulations.

Gap analysis for IVDD to IVDR:

The In Vitro Diagnostics Directive (IVDD) 98/79/EC was updated to create a more reliable and predictable system for regulating in vitro diagnostic medical devices. This new system ensures higher safety and health standards while encouraging innovation.

The In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746 came into effect on 25 May 2017, with a five-year transition period for manufacturers and operators. The goal of the IVDR is to strengthen the regulatory framework for in vitro diagnostic devices, making sure they meet high health protection standards for both patients and users.

The IVDR introduces major changes to how in vitro diagnostic devices are regulated, including:

  • Device reclassification based on risk levels
  • Expanded product scope
  • More detailed scientific validity and performance evaluations.
  • Post-market surveillance systems and practices to collect Post-market Performance Follow-ups.

Other updated requirements for in vitro diagnostic devices like compliance with the Common Specifications.

If you’re currently certified under the IVDD and your certificate is about to expire, or if you want to stay ahead by complying with the latest regulations, Maven can assist you. Our team of experts is experienced in performing a detailed IVDD to IVDR gap analysis, tailored to your product, certification cycle, and notified body.

We conduct a thorough review of your technical documentation, procedures, processes, and quality management system (QMS). Our gap analysis covers:

Gap-analysis-for-IVDD-to-IVDR
  • Product classification
  • Performance evaluation report review
  • Risk management review
  • Technical files and design files
  • Information materials (IFU/Labels)
  • Post-market surveillance activities (Protocols, plans, procedures)
  • European Authorized Representative (EC REP) agreements
  • Supplier & distributor documents (Agreements, procedures)
  • Testing (Internal & External)
  • Compliance with Common Specifications

Gap Analysis of Quality Management System for EU MDR & IVDR Compliance

Gap-Analysis-of-Quality-Management-System

The new EU MDR and IVDR regulations introduce a range of updates that medical device companies need to take seriously. These include changes to device classification, expanded technical documentation requirements, and significant updates to how your Quality Management System (QMS) is structured and maintained.

Having ISO 13485 certification is still the foundation for CE marking, but that’s no longer enough on its own. Your QMS now needs to fully align with the latest EU MDR and IVDR requirements. That means revising existing procedures and creating entirely new ones in areas like post-market surveillance, clinical evidence, and economic operator registration.

Here’s the thing—staying compliant today means thinking beyond just Europe. Your QMS needs to meet international expectations too. That’s where our QMS Gap Analysis service comes in. We assess your system against ISO 13485, FDA’s 21 CFR Part 820, and the MDSAP framework, which bundles requirements from regulators in multiple countries.

We start with a structured review of your documentation, controls, and processes. This includes a detailed look at how your company handles production and process controls, risk management, internal audits, CAPAs, supplier qualification, change control, and recordkeeping. The goal? To see how well all these elements work together as a single, audit-ready system.

Instead of giving you a generic checklist, you’ll get a clear and prioritized roadmap showing what’s missing, what needs fixing, and how to future-proof your QMS. This is especially critical if you’re transitioning from MDD to MDR or IVDD to IVDR. A strong QMS gap analysis helps identify specific areas of non-compliance and lays the groundwork for a smooth regulatory transition. It also directly feeds into your MDD Vs MDR Gap Analysis by showing exactly where your system falls short under the new rules.

Key procedures that will need to be updated or developed include:

  • Post-market surveillance system
  • Clinical evidence management
  • Resource Management / Supply Chain Procedures
  • UDI and Labeling Procedures
  • Registration of Economic Operators
  • EUDAMED Registration Procedures
  • PSUR Strategy
  • Regulatory Compliance Strategy
  • General Safety and Performance Requirements
  • Appointment of the Person Responsible for Regulatory Compliance (PRRC)

Adapting to new regulations takes more than just ticking boxes. It requires a full understanding of what’s changed, how those changes impact your current system, and what needs to be done to meet both EU and international standards. Whether you’re targeting your first ISO certification, planning market expansion, or preparing for a multi-country audit, we can help make your QMS audit-ready and future-aligned.

If you’re still navigating the shift from IVDD to IVDR or working through your MDD Vs MDR Gap Analysis, now is the time to act. A thorough gap analysis isn’t just useful—it’s essential.

Gap Analysis for Transition to New Standards

Medical devices and in-vitro diagnostic devices must follow different standards and guidelines. These standards can be general or very specific to the product, process, testing, or performance. As science and technology evolve, these standards are updated to include new requirements. Keeping up with these updates can be challenging, and it may be difficult to ensure everything is in line with the latest regulations. Even when updates are recognized, understanding how to follow them can be tricky.

Maven can help you stay on top of the latest updates in standards and guidelines. We offer gap analysis services to evaluate your existing processes and systems. Our team will review your compliance with the relevant standards and identify where your system meets or does not meet certification requirements. We will then create a basic plan to address any gaps.

This gap analysis will help your organization prepare for initial audits and certification, ensuring you’re fully ready to meet new regulatory standards.

Gap-Analysis-for-transition-to-new-version-of-the-standard

Frequently Asked Questions

A regulatory gap analysis for medical devices is a systematic review that compares your current documentation, processes, and Quality Management System (QMS) against the requirements of updated regulations or standards (like EU MDR, IVDR, or ISO 13485). It helps identify missing or non-compliant areas and provides a clear roadmap to meet regulatory expectations, ensuring a smooth certification or transition process.

A gap analysis is crucial for MDR/IVDR compliance because it identifies the differences between a manufacturer’s current documentation, processes, and technical files versus the requirements of the new regulations. It helps pinpoint missing elements, outdated data, and non-conformities, allowing for targeted corrective actions. Without a gap analysis, manufacturers risk non-compliance, delayed certification, or regulatory penalties. It ensures a structured transition to MDR/IVDR by prioritizing updates, reducing time to compliance, and minimizing costly surprises during Notified Body audits.

A gap analysis should be conducted at the beginning of your certification or transition journey—whether you’re shifting from MDD to EU MDR, IVDD to IVDR, or updating your QMS to include 21 CFR or MDSAP or to meet new regulatory standards. It helps identify missing elements in your documentation, processes, or technical files so you can take timely corrective actions and avoid delays due to notified body reviews or certificate expiry. It is also done when a standard or regulation changes, or if you are updating technical documentation post-design changes or entering new markets with different regulatory requirements

During a gap analysis, key areas typically reviewed include your technical documentation, product design files, clinical evaluation reports, risk management files, labeling (IFU), post-market surveillance activities, agreements with suppliers/distributors, and testing data. Additionally, the Quality Management System (QMS) is assessed to ensure alignment with regulatory requirements such as EU MDR or IVDR. The goal is to identify missing or insufficient elements and recommend actionable steps to achieve full compliance.

Maven Profcon Services LLP offers expert-led gap analysis services to help medical device manufacturers identify and address gaps in their technical documentation, QMS, and regulatory compliance. Whether transitioning from MDD to EU MDR, IVDD to IVDR, or updating to a new standard, our team thoroughly reviews your files, processes, and procedures, highlights deficiencies, and provides actionable solutions—ensuring your readiness for certification and regulatory audits.

Connect With Us