The importance of medical writing has been highlighted over the years in healthcare and, notably, for medical devices. Approval from the Regulatory agencies is highly dependent upon the scientific documents devised. Further, the continuous innovation in the medical device industry has simultaneously strengthened and changed the scope of medical writing. Given the increasing complexities in the current scenario, manufacturers face considerable challenges while placing the devices in the market. Some of the key challenges are listed below:

The operation manual is the most official and comprehensive reference to the operation and maintenance of a product or a device. Manuals provide conceptual information, such as design theory. An operating manual must contain all relevant information, features, procedures, and tasks to install, update, maintain and remove the product or software. It should also describe the main tasks and solutions to typical problems or questions in detail for the user.

The National Health Surveillance Agency of Brazil (ANVISA) published a resolution RDC no. 657 on March 30, 2022, regulating Software as a Medical Device (SaMD). The resolution has been effective since July 1, 2022.

The adaptation of medical writing bloomed through the ever-evolving medical device industry coupled with the implementation of stringent regulations in the countries. Given the dynamic nature of the medical device industry, it is noticed that manufacturers who aim to place their medical device/s in the market are focusing diligently on medical writing for Regulatory approvals, as it involves drawing up a structured document complying with the Regulatory requirements. Several techniques and tools have been devised and are still being developed to implement effective documents.

The clinical evaluation is a procedure for demonstrating the safety and efficacy of the medical device. The documentation of the clinical evaluation process is called a Clinical Evaluation Report (CER). CER holds a significant position when placing or distributing medical devices in the European Union (EU). The report aims to establish the device’s intended benefits for users when weighed against the associated risks.

The most significant and crucial step in the device approval process is the labeling aspect. The safe and proper use of medical devices by patients and those who provide care for patients depends on accurate labeling with all the necessary information to ensure market access. Article 63 of the " Act on Securing Quality, Efficacy, and Safety of Products, Including Pharmaceuticals and Medical Devices" specifies medical device labeling regulations for manufacturers who intend to market their products in Japan.

The establishment of European Union Medical Devices Regulations (EU MDR) 2017/745 and In Vitro Diagnostic Devices Regulations (EU IVDR) 2017/746 posed additional requirements. The significant aspect highlighted was implementing the Post-Market Surveillance system (PMS). Enabling PMS will ensure the devices' safety even after being launched in the market.

In-Vitro diagnostics (IVD) are products that are reagents, instruments, or systems that can detect diseases or other conditions and monitor a person’s overall health to help cure, treat, or prevent diseases.

The classification of an IVD determines the appropriate premarket process for approval. The FDA classifies IVD products into Class I, II, or III based on the associated risk.

1. What is the FDA Q-submission program?

Q-submission FDA program refers to the system that tracks the collection of interactions with the FDA. It helps manufacturers of Medical Devices and in vitro diagnostics (IVDs) to obtain feedback from the FDA regarding Regulatory processes and requirements for the product during its development.

As you may know, CE marking is required to place any In Vitro Diagnostics devices (IVDs) in the European Union (EU). CE marking indicates that the given product complies with the European Union In Vitro Diagnostics Device Regulations (EU IVDR) 2017/746. We are all aware that the process is more complex than it seems.

This article provides a few crucial pointers that should be noticed to avoid significant mishaps.  

1. Careful Assessment and Applicable Rules for Classifying the Device