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 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.

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

Medical device labeling is a critical part of any device. It provides information to the consumer in textual or graphic forms on the packaging. It intends to increase the safety and usage instructions for consumers. When there is a false or misleading label, it is regarded as a misbranded medical device or adulterated medical device. It is considered a legal offense when a device fails to report essential product information based on its judicial requirements.

Labeling is defined as the “display of written, printed, or graphic matter upon the immediate container of any article.” Any medication that is intended to be distributed must be labeled as per the Parts of Title 21 of the Code of Federal Regulations (CFR).

An organized system of protocols and practices known as a medical device quality management system (QMS) addresses all facets of design, production, supplier management, risk management, complaint handling, clinical data, storage, distribution, product labeling, and more. The goal of the QMS is to continuously meet consumer and Regulatory requirements while also improving the quality of medical devices and related services.

The importance of post-market surveillance (PMS) has never been out of the buzz. Regulatory Authorities worldwide have established some stringent rules and regulations to efficiently monitor medical devices even after placing them on the market. Similarly, the European Union (EU) has emphasized PMS in its new regulations. Many requirements have been implied on the manufacturers, one of them being the Post-Market Surveillance Reports (PMSRs).