MDR Technical Documentation is the key to faster CE Certification

MDR technical documentation refers to the comprehensive set of documents and supporting evidence that manufacturers must prepare to demonstrate that their medical device complies with the requirements of the EU Medical Device Regulation (MDR) 2017/745, Annex II. This documentation provides detailed information about the device, covering its entire lifecycle, from design and development to manufacturing, clinical evaluation, and post-market surveillance. Impact on Medical Device Manufacturers

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The technical documentation file is based on addressing the vitals covered in the General Safety and Performance Requirements (GSPR) covered in Annex I. The financial and operational burdens of covering the necessary GSPR requirements are particularly challenging for small and mid-sized manufacturers. Many companies have already invested heavily in engaging Notified Bodies and conducting testing, only to face prolonged delays in the clearance of technical and clinical documentation. This has forced some to delay product launches or remove devices from their CE-certified portfolios.

The Medical Device Regulation (MDR) 2017/745 has introduced stringent requirements for technical documentation, making it a cornerstone for achieving CE certification. This documentation serves as comprehensive evidence of a device's biological and clinical safety, performance, and compliance with international standards. It encompasses detailed information on device design, manufacturing processes, clinical evaluation, risk management, and post-market surveillance plans. High-quality, well-structured technical documentation not only accelerates the certification process but also demonstrates a manufacturer’s commitment to regulatory excellence. Ensuring robust technical documentation is essential for MDR approval.

 Overcoming Technical Documentation Challenges Faced by Medical Device Manufacturers

Medical device manufacturers often face significant challenges in completing MDR-compliant technical documentation. These challenges include

• The MDR 2017/745 has stringent and detailed requirements for technical documentation, including clinical evidence, risk management, and post-market surveillance. Manufacturers may struggle to interpret and implement these requirements effectively, leading to gaps in compliance.
• Preparing technical documentation requires extensive effort, from compiling design and manufacturing details to generating clinical and performance evidence. Without expert guidance, manufacturers may waste time on trial-and-error approaches or unnecessary documentation.
• Demonstrating clinical safety and performance through robust clinical evaluation is a core requirement under MDR. Manufacturers often face difficulties in (a) Identifying applicable equivalence claims or not knowing the alternate solutions. (b) Conducting clinical evaluations or clinical trials/investigations (c) Documenting evidence in the format required by Notified Bodies.
• Risk management, aligned with ISO 14971 latest version, is a critical aspect of technical documentation. Manufacturers may have insufficient expertise in identifying, analysing, and mitigating risks systematically, leading to incomplete or non-compliant risk files.
• PMS and Periodic Safety Update Reports (PSURs) are mandatory under MDR. Many manufacturers struggle to create compliant surveillance systems and integrate real-world data into their documentation.
• Resource Limitations are one of the key issues faced by small and medium-sized enterprises (SMEs). They lack dedicated regulatory teams or resources, making it even more difficult to meet MDR’s technical documentation requirements independently.
• Incomplete or poorly structured documentation can result in multiple queries and rejections during Notified Body reviews, causing delays in CE certification.

Challenges Faced by Manufacturers in the Regulatory Process: A CEO's Concern

A CEO of an SME company raised his concerns to the media: "We have been in this process for the last two years, and we are still in the dark, with no clear understanding of the current status. There has been no response from the Notified Bodies about the timeline. We have two dedicated regulatory team members working on this project, and we have spent a lot of money on testing and validations”.

Understanding the Frustrations - Recommendations from Experts and How I3CGLOBAL Can Assist

Soio George, Technical Director of I3CGLOBAL, a leading medical device consulting firm with global operations, commented,

“I understand the frustration that many manufacturers have shared with me earlier also. Financial constraints and timelines are the core challenges that can be overwhelming. One strong point I need to emphasize to all manufacturers is that partnering with the right consulting company, equipped with experienced and dedicated resources for every critical topic, can significantly reduce costs and expedite the review process”

Here’s how the technical team assist with:

• Our strong working relationships with various Notified Bodies, enabling us to facilitate smoother communication and provide proactive updates on your submission status. Our experts reply to all queries raised by the reviewer.
• Our team of experts can help you interpret and meet complex regulatory requirements, reducing the chances of delays or resubmissions.
• We assist in planning and executing the necessary testing (Biocompatibility and Electrical Safety) and validations, ensuring they are in line with the regulatory standards and that all evidence (Protocols and reports) is properly documented.
• We offer tailored support for your regulatory team, ensuring they are equipped with the latest regulatory knowledge and strategies to minimize delays and costs.

We aim to alleviate the burden of the regulatory process and help manufacturers export medical devices to the EU market faster while ensuring full compliance with the MDR.

Conclusion

Navigating the complex regulatory landscape under EU MDR can be a daunting process for manufacturers. Early planning of the budget and identifying the necessary testing requirements, with the assistance of experienced MDR consultants, will greatly enhance the CE certification journey. With the right expertise and support, any challenges can be effectively managed, leading to an accelerated regulatory process.

Manufacturers who partner with regulatory consultants like I3CGLOBAL can ensure that their technical documentation is compliant, minimize the risk of non-conformities, and ultimately achieve faster market access under the EU MDR. The key is to invest in the right support to confidently and efficiently navigate the evolving regulatory landscape.

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