Near-patient Testing (NPT) has the fastest-growing market in the IVD segment. Europe is the second-largest market after the United States for NPT. Many companies are trying to launch their NPT products in the European Union (EU), and now with the implementation of In Vitro Diagnostic Medical Device Regulation (EU IVDR) 2017/746, the companies are transitioning towards it.
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.
