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Navigating EU MDR Certification: Tips for Manufacturers

This is part 3 of our article series for manufacturers of medical devices about the challenges and strategies for managing MDR transition.

The European Union Medical Device Regulation (MDR) brings forth a paradigm shift in the certification process, demanding a more patient-centric and risk-focused approach. Successfully obtaining CE marking requires manufacturers to go beyond the exchange of acronyms and delve into robust risk mitigation strategies, detailed safety evaluations, and thorough documentation. This article provides a roadmap with practical steps and invaluable tips to prepare for EU MDR certification and explores the transformative possibilities that digitalization offers for product design and documentation processes in the context of EU MDR. Also, we show opportunities for improvement during the waiting period for a Notified Body agreement and describe a product-oriented approach for streamlined and effective documentation.

Roadmap for MDR compliance

Real Adoption: Patient-Centric Risk Mitigation

  • Intended Use and Indications: Sharpen the definition of your device's intended use and indications, highlighting its differentiating safety features compared to other products on the market.

  • Focus on Patient Risks: Prioritize understanding the potential risks your medical device poses to patients. Conduct a thorough risk assessment, emphasizing patient safety as a paramount concern.

  • Clinical Proof of Safety: Gain clinical evidence to substantiate the safety claims of your device. Conduct rigorous testing and clinical trials to validate the safety of your device in real-world scenarios.

  • Proactive Market Safety Monitoring: Implement a proactive approach to monitor the safety of devices throughout their product lifetime. Collect and analyze post-market surveillance data to identify potential safety issues early on.

Detailed Evaluation of Technical Design and Manufacturing

  • Traceability: Create a comprehensive traceability system for all components and materials used in your device. Establish clear links to suppliers and track changes over time.

  • Risk Management for Materials and Processes: Conduct detailed risk management activities specifically focused on the materials and manufacturing processes involved in your device. Identify potential hazards and implement mitigation strategies.

Prove Device Safety in Clinical Use

  • Plan Clinical Evaluation: Develop a robust plan for clinical evaluation based on the outcomes of your risk management activities. Clearly demonstrate how clinical use aligns with the intended use and safety features of your device.

  • Continuous Market Feedback: Establish mechanisms for continuous feedback evaluation from the market. Regularly update your clinical evaluation based on real-world performance and user experiences.

Enhance Technical Files with Design Details

  • Ensure Traceability: Strengthen your technical files by ensuring traceability to safety-relevant components. Clearly document the origin and characteristics of each component.

  • Prove Safety During Design: Provide comprehensive evidence of safety during the design phase. Demonstrate that safety considerations were integral to the design process, and validate the safety of each component.

  • Digital Documentation Tools: Leverage digital documentation tools to enhance transparency and facilitate change management. Ensure that your documentation allows for the identification of components, materials, and substances throughout the device's lifecycle.

Get Digital to Meet Regulatory Requirements

As the European Union Medical Device Regulation (MDR) reshapes the landscape for medical device manufacturers, embracing digitalization becomes not just an option but a strategic imperative. In the eleventh hour of MDR implementation, the chances for digitalization go beyond mere checklists and consultants. 

Chances for Digitalization "Last Minute"

Beyond Checklists and Consultants

While checklists and consultants play a crucial role, the real potential lies in a comprehensive digital transformation that permeates every aspect of the product lifecycle.

New Ways to Disclose Product Knowledge

Digitalization provides a platform for transparently disclosing intricate knowledge about products. Advanced tools enable a dynamic and accessible repository of information that evolves with the product.

Core Role of Risk Management

Risk management is not just a regulatory checkbox; it's a core activity to prove product safety by design, in manufacturing, and during use.

Traceability Challenges

Maintaining traceability in risk management is challenging with traditional tools like Excel. Digital tools become imperative to manage multi-aspect risk evaluation, dependencies, change control, and configuration management.

Implement Digitalization

Set Up Digitalized Risk Analysis

Begin by establishing a digitalized risk analysis system that delves into the necessary depth of both product and process architecture.

Utilize Comprehensive Tools

Choose tools that facilitate multi-aspect risk assessments, accommodating various levels and categories of product and process traits.

Risk Management as a Guide

Use risk management as a guiding map into your MDR-compliant device documentation. Align your digital tools with the intricacies of MDR requirements.

Enhanced Clinical Evaluation Planning

Leverage risk management insights to identify areas requiring more data, thus creating reliable plans for clinical evaluation and ensuring data adequacy.

Auditing Advantages

A focus on risk management provides advantages during audits. It allows for clearer communication with Notified Bodies (NBs) and auditors, demonstrating a proactive approach to safety.

Traceability Builds Trust

Digital tools facilitate clear traceability through versions and variants, building trust in audits by showcasing a detailed history of design elements.

Prioritization and Efficiency

Risk management enables prioritization, reducing the workload required to bridge the MDR compliance gap to a minimum.

Guiding NB Reviewers

The narrative created by a robust risk management approach serves as a guide for NB reviewers, offering clarity on the safety considerations integrated into the product. 

Chances for Improving While on the Waiting List for NB application

Introduction of the MDR also  requires dealing with the inevitable waiting period until a Notified Body (NB) accepts the application. Rather than considering this time as idle, manufacturers can strategically utilize it to enhance their application documentation.While waiting for an NB to accept your medical device application, don't let the time slip away. Seize the opportunity to fortify your submission by adopting a product-oriented documentation approach. Focus on clarity, traceability, and risk management, ensuring that your application not only meets the regulatory requirements but stands out as a robust and comprehensive representation of your medical device. This proactive strategy not only improves the chances of a smoother review process but also positions your product for success in the competitive landscape of medical device regulation.

Preventing NB Resistance

NBs are likely to resist reviewing insufficient submissions. This opens the door for applications with a conclusive and straightforward documentation attitude. Utilize the waiting time to ensure your submission is robust and leaves no room for ambiguity.

Focus on Product-Oriented Documentation

Rather than inundating the application with an excess of documents, focus on creating product-oriented documentation. Directly align documentation with the intricacies of your medical device, emphasizing its design, functionality, and safety features.

Incremental Documentation According to Product Architecture

Break down the documentation process incrementally based on the architecture of the product. This approach allows for the multiple reuse of the same information across different sections, reducing redundancy and enhancing the overall coherence of the submission.

Strategies for Product-Oriented Documentation

Clearly Define Product Features

Use the waiting period to refine and clarify the documentation related to the features of your medical device. Provide a comprehensive overview of its intended use, specifications, and unique selling points.

Enhance Risk Management Documentation

Dig deeper into risk management documentation. Clearly articulate the risks associated with your device and present comprehensive strategies for mitigation. This not only strengthens the safety narrative but also aligns with MDR requirements.

Ensure Traceability Across Documentation

Utilize the time to enhance traceability across various documents. Ensure that each piece of information seamlessly connects to others, creating a cohesive and transparent narrative that facilitates easier understanding during review.

Review and Validate Clinical Data

If clinical data is part of your submission, dedicate time to review and validate its relevance and accuracy. The waiting period provides an excellent opportunity to fine-tune this critical aspect of your application.

Optimize Post-Market Surveillance Plans

Refine your post-market surveillance plans. Clearly outline how you intend to monitor the performance and safety of your device once it is on the market. This proactive approach showcases a commitment to ongoing safety.

Seek External Expert Opinions

Use the waiting time to seek external expert opinions. Engaging with consultants or regulatory experts for a fresh perspective can uncover potential gaps and areas for improvement in your documentation.

In the final stretch before full EU MDR implementation, medical device manufacturers have a unique opportunity to leverage digitalisation for compliance. By embracing comprehensive risk management solutions and integrating digital tools into their product design and documentation processes, manufacturers not only meet regulatory requirements but also lay the groundwork for a more efficient, transparent, and resilient future in the ever-evolving landscape of medical device regulation.

Navigating the EU MDR certification process demands a holistic approach that goes beyond the surface. By adopting a patient-centric mindset, meticulously evaluating technical design and manufacturing processes, proving safety through clinical use, and enhancing technical files with detailed design information, manufacturers can position themselves for success in achieving CE marking and ensuring the highest standards of safety and efficacy for their medical devices in the European market.

Most important tips in short

Identify a Notified Body!

Do your homework of QM and documentation right from the beginning!

Use real digital documentation (eTD) and QM (eQMS) systems that support creation of information before you need to care for final document structure.

Do not start with Excel and Word just because it is less effort using them - you value lies in information, so decide careful how to manage that!

Also look into the former parts of this series about goals, challenges and strategies for MDR compliance:

About the Author
Regina Preysing
Partnerships Manager