Maintaining MDR/IVDR Technical Documentation is a Challenge Even After Certification

Michael M. Kania
July 14, 2023
Medical Device Regulation

In the ever-changing landscape of regulatory affairs, companies are constantly looking for efficient solutions to automate their Medical Device Regulation (MDR) and In-Vitro Diagnostica (IVDR) reporting. This is where Electronic Technical Documentation (eTD) comes into play. The benefits of implementing an eTD system are numerous, and even greater for companies that maintain multiple technical documentations and have products registered in multiple countries.

Streamline regulatory reporting

The journey doesn't end with obtaining an MDR / IVDR certificate or submitting technical documentation to a Notified Body. In fact, it's just the beginning. After the successful market entry, companies must prepare for the next MDR & IVDR surveillance audit and offsite reviews. This requires a well-thought-out strategy that includes post-market surveillance (PMS) including PSUR, clinical evaluation reports, post-market clinical follow-up, and risk management maintenance.

Improving efficiency and scalability

The regular maintenance associated with these processes and documents is overwhelming. But adding more regulatory affairs staff isn't the most scalable solution. Instead, companies should focus on leveraging the expertise of their existing regulatory affairs staff and empowering them with state-of-the-art regulatory affairs software solutions. SaaS (Software as a Service) tools are a very fast way to start within days and start reaping digital benefits instantly.

An eTD system is a perfect example of such a tool. It provides a digital platform for managing technical documentation, enabling regulatory affairs professionals to more efficiently perform their daily tasks in the medical device and in vitro diagnostic (IVD) field.

Cost-effective in the long run

While there is a cost associated with implementing an eTD system, it is important to consider the long-term financial impact. Hiring additional regulatory affairs professionals, especially those with less experience in your organization, can result in significantly higher costs over the next 5 to 10 years.

In contrast, investing in an eTD system is a strategic move that can result in significant long-term cost savings. Not only does it reduce the need for additional staff, it also streamlines workflows and increases overall productivity of the existing staff.

Build a strong and modern regulatory strategy

Implementing an eTD system is more than a tactical decision; it's a strategic move that can shape the future of a company's regulatory affairs. By evaluating the right processes and workflows for your organization, you can build a solid regulatory strategy capable of navigating the complexities of regulations.

The benefits of using electronic technical documentation are manifold. From streamlining crucial regulatory reports / documents and increasing efficiency to providing long-term cost savings and helping to build a strong regulatory strategy, eTD is a game changer in the world of regulatory affairs.

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