Review existing products as a starting point
Before you revise the technical documentation, get an overview of the products for which you must demonstrate compliance with the MDR requirements. Part 1 of this series describes a six-step process model for this purpose.
The white paper guides you through the process, starting with the organization of your products, moving on to the review of the intended use, indications, and product description, and concluding with classification. Finally, it focuses on identifying the applicable essential safety and performance requirements. This will help you establish a technical foundation for the further review of your documentation.
Identify gaps in evidence and documentation
Are the MDR requirements for your product already covered by existing information and documentation? A GAP analysis highlights which requirements are met and where documentation needs to be supplemented or revised.
Part 2 explains how to examine requirements individually and compare them with the current status for a specific medical device. The white paper covers the fundamental safety and performance requirements from Annex I, the technical documentation required by Annex II, and post-market surveillance as specified in Annex III. Examples illustrate how the results of such an assessment can be documented.
Structuring Technical Documentation Clearly
Once the gaps are identified, the focus shifts to compiling the content. What information does the MDR require, in which documents is it presented, and how can the Notified Body locate the relevant supporting documentation?
Part 3 provides an overview of the contents of the technical documentation in accordance with Annex II of the MDR and outlines possible ways to structure it. Among other topics, the white paper addresses the product description and other areas of documentation. It also explains why clear chapter and document names—as well as collaboration between Regulatory Affairs and the technical departments—are important.
Address identified gaps and keep the documentation up to date
The CAP analysis identifies specific tasks: You may need to supplement supporting documentation, update documents, or account for changes to the product. Part 4 outlines the questions that can help you plan this work and explains how to organize the associated tasks.
The white paper also examines the post-market phase. Product changes, new legal or regulatory requirements, and findings from monitoring may necessitate adjustments to the technical documentation. Part 4 thus links the process of closing identified gaps with the ongoing maintenance of the documentation.
