Label maintenance and updating is the process of ensuring that the data on the label stays up-to-date and accurate throughout the life cycle of the device. This could entail updating information to meet new laws or standards, amending the existing labels to reflect changes in the product or its intended use, or fixing typographical errors.

The European Union Medical Device Regulation (EU MDR) 2017/745 is a regulation that sets out the requirements for medical devices in the EU. The regulation provides the evaluation of medical devices prior to marketing, and one of the key requirements is the need for clinical investigations. Clinical investigations are necessary to assess a device’s safety and performance and demonstrate that it meets the requirements of the EU MDR. Under the EU MDR, the clinical investigation has been divided into three (03) components –

As stated in the European Union Medical Devices Regulations (EU MDR) 2017/745, clinical investigation, is “any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device” The entire purpose of clinical investigations is to demonstrate that medical devices are safe and effective when used for their intended purpose.

One may think that placing a medical device on the market is the final step; however, even after the device’s launch, the manufacturer is required to fulfill the Post-Market Surveillance (PMS) requirements. PMS involves activities to collect and evaluate the feedback/complaints related to the quality, performance, and safety of the devices, user surveys, technical and clinical watch, surveillance of competing devices throughout the device’s lifetime and take any corrective actions if necessary.

The importance of medical writing has been highlighted over the years in healthcare and, notably, for medical devices. We can say that the approval from the Regulatory agencies is predominantly dependent upon the medical writing of the medical devices, i.e., the scientific documents devised for the devices. Further, the continuous innovation in the medical device industry has simultaneously strengthened and changed the scope of medical writing.

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.

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).

In a global marketplace with more than 7,100 spoken languages, manufacturers need to consider the local language and culture when developing medical device product labels. How does one make it possible to reach out to a diverse group of people?

One of the time-tested ways is the use of medical device symbols. It can convey a significant amount of information in a small space. Although it is optional, using symbols on the labeling of medical devices is strongly advised. It offers benefits to both users and manufacturers, such as:

The medical device industry is undergoing continuous transformation to comply with the ever-changing Regulatory guidelines introduced by global Regulatory authorities to ensure strict controls over device performance and safety. In such a scenario, having a better understanding of the medical devices, Regulatory Affairs, and updated Regulatory information to design and implement a strategy can result in reduced costs, time-to-market, and maximum compliance.

The medical devices and In Vitro Diagnostic devices (IVDs) under the European Union Medical Device Regulation (EU MDR) 2017/745 and In Vitro Diagnostic Devices Regulations (IVDR) 2017/746 are categorized into four (04) classes and twenty-two (22) rules (MDR)/ seven (07) rules (IVDR). Compared to the previous scope of the product in the Directives, the current regulation has expanded its scope. For instance, the EU MDR now covers contact lenses as well.