While placing your medical device on the European Union (EU) market, obtaining CE marking is a mandatory step. This is essential to assure the end user that the devices available in the market are both safe and effective for use. A critical component for providing this assurance involves a thorough examination of the technical documentation for the medical devices.
The European medical devices market, being the second largest in the world, is majorly driven by a growing patient population, technological advancements, and increasing healthcare expenditure. However, when it comes to expanding the medical device business into the European geography, a complex web of regulations and recent geopolitical changes adds an extra layer of challenge.
In Vitro Diagnostic (IVD) devices play a crucial role in healthcare by providing valuable information for disease diagnosis, patient monitoring, and treatment decisions. The European Union's In Vitro Diagnostic Regulation (IVDR) 2017/746 introduced a new classification system for IVDs.
The implementation of the In Vitro Diagnostic Regulation (IVDR) 2017/746 on May 26, 2022, has resulted in heightened scrutiny and Regulatory supervision for In Vitro Diagnostics (IVDs) in the European Union (EU).
A Performance Evaluation Report (PER) is a comprehensive clinical document that demonstrates the safety and performance of In Vitro Diagnostic (IVD) devices. It is mandatory for manufacturers to submit this document to place their IVDs in the European Union (EU) market. The PER is built on the foundation of the following three (03) pillars of data demonstration:
CE marking is mandatory for all devices that are to be sold in the European Union (EU) countries. Similarly, In Vitro Diagnostic (IVD) devices must also obtain a CE marking and undergo a rigorous approval process to demonstrate their safety and efficacy. They have to abide by the requirements mentioned under the EU In Vitro Diagnostic Device Regulation (IVDR) 2017/746. Each device has a specific set of requirements and procedures that they need to follow. In fact, the Regulatory requirements can be complex and challenging to follow.
With the implementation of the European Union (EU) In Vitro Diagnostic Devices Regulations (IVDR) 2017/746, the Performance Evaluation Report (PER) has changed dynamically in terms of its requirements and approach.
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.
