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Gap Analysis

Gap Analysis

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

A Gap Analysis is a strategic planning tool to help you understand where you are, where you want to be and how you’re going to get there. A gap analysis is mainly done at the beginning of the certification journey to assess what is currently in place against the set of requirements for which every standard is to be implemented.

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

Gap analysis for MDD to EU-MDR:

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

EU-MDR was released in April 2017, which is more focused on a high level of protection for the health of patients and users. This regulation set a high standard to prove quality and safety for medical devices.

If you are already certified under MDD 93/42/EEC and well aware of that fact that your certificate will expire pretty soon in upcoming years, it is only advisable to be proactive and smartly start planning your transition strategy for CE to avoid documentation back logs and delays due to Notifying body shortages. If you want to initiate the gap analysis for your product range and you have confusion from where to start and how to start, Maven is here to help you.

We can perform an in-depth gap analysis of your technical documentation, procedures, processes, and QMS, and provide you best solution to initiate the process for EU-MDR to save your time and efforts of interpreting the Regulation and get your devices certified under EU-MDR. Gap analysis done by our product experts includes a review of your;

  • Technical File
  • Design files
  • Product classification
  • Clinical evaluation report review
  • Risk Management report review
  • Information materials (IFU/Labels)
  • Post marketing Surveillance activities (Protocols, plans, procedure, effectiveness and report)
  • European Authorized Representative (EC REP) agreement
  • Supplier & distributor related documents (Agreements, procedures)
  • Product related Testing (Internal & External)
  • Vigilance

We will give you detailed report of deficiencies in each document and also provide you the solution to fix them.

We also provide you the details of additional documents and information as per the requirement of your product to comply with the requirement of the regulation.

Gap analysis for IVDD to IVDR:

The In Vitro Diagnostics Directive (IVDD) 98/79/EC (IVDD) for in vitro diagnostic medical devices is revised to establish a robust, transparent, predictable, and sustainable regulatory framework for in vitro diagnostic medical devices which ensure a high level of safety and health whilst supporting innovation.

The aim of the new In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746 is to ensure the smooth functioning of the internal market as regards in vitro diagnostic medical devices, taking as a base a high level of protection of health for patients and users.

The IVDR is applicable to in vitro diagnostic (IVD) medical devices. Entering into force on 25 May 2017 providing a five-year transition period for manufacturers and economic operators.

The new regulation for in vitro diagnostic device provides significant changes to the regulatory requirement for an e.g. reclassifying the device based upon the risk, product scope extension, more precise clinical evaluation for in vitro diagnostic (IVD) medical devices, etc.

If you are already certified under 98/79/EC (IVDD) and your certificate is due expiry or you wish to proactively comply to the updated regulation, Maven can help you with our bunch of experts who are involved in gap analysis based upon your product range, certification cycle, and your notified body.

We can perform an in-depth gap analysis of your technical documentation, procedure, process, and QMS, and recommended you how to fill the gaps, Gap analysis is done by our product experts and includes a review of your;

Gap-analysis-for-IVDD-to-IVDR
  • Technical File
  • Design files
  • Product classification
  • Clinical evaluation report review
  • Risk Management report review
  • Information materials (IFU/Labels)
  • Post marketing Surveillance activities (Protocols, plans, procedure, effectiveness and report)
  • European Authorized Representative (EC REP) agreement
  • Supplier & distributor related documents (Agreements, procedures)
  • Product related Testing (Internal & External)
  • Vigilance

Gap Analysis of Quality Management System for compliance to EU MDR & EU IVDR.

Gap-Analysis-of-Quality-Management-System

The new requirements imposed by EU MDR & EU IVDR involve several changes that medical device companies must be prepared for, including things like device classification and updating your QMS. It requires all QMS documentation and records to be a seamless system of information and data.

While being certified with ISO 13485 is the basic requirement for complying with the requirements of CE marking, it must now ensured that this QMS is compliant to the new MDR criteria. This includes preparation of some additional procedures and modification of certain existing procedures. Following are the procedures that shall either be updated or prepared:

  • Procedure for Post-market Surveillance System
  • Procedure for Clinical Evidence
  • Procedure for Resource Management / Supply Chain
  • Procedure for UDI and Labeling
  • Procedure for registration of Economic operators
  • Procedure for EUDAMED registration
  • Procedure for PSUR
  • Strategy for Regulatory compliance
  • General Safety and Performance Requirements
  • Appointment of PRRC

Change in a regulation can be difficult to interpret, document, implement and maintain and that’s where we come in, us as your regulatory partners with our understanding on the key changes in the MDR, shall conduct a GAP analysis to understand where you are now, and where you need to be to comply.

Gap Analysis for transition to new version of the standard

There a multiple standards and guidelines applicable to a single medical and in-vitro medical device. These standards range from being generally applicable to being product specific, process specific, testing specific or performance specific. With advent in science and technology and expansion of our understanding, these standards are upgraded to cover more and more requirements and specifications. Keeping up with such upgrades may not always be feasible and can create limitations while complying with regulatory requirements. Even if acknowledged, interpreting the standard and doing as required can be tricky.

Maven can help you keep up with the latest upgrades in any standards and guidelines and perform gap analysis of your existing processes and procedures. We shall review the compliance of your applied system to the requirements of the appropriate standard. Document where your system complies / does not comply with the certification requirements and provide a basic plan of mitigating these gaps.

This will enable your organization to implement a strategy to remedy these gaps in readiness for the mandatory initial audits for certification.

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.

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