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 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).

Class A IVDs under European Union In Vitro Diagnostic Devices Regulations (EU IVDR) 2017/745 require self-certification. The manufacturer is required to self-declare their product’s compliance with the EU IVDR’s requirements and affix the CE marking.

While the process for self-declaration seems easy compared to other device routes, the intricates, when ignored, can create complications in placing the device in the EU market. Below are some of the key points that manufacturers need to note while placing Class A devices on the market:

COVID-19 lead to a global health crisis, imposing the greatest challenges for medical communities. The threatening patterns of pandemic transmission and rapid rate of contagion invoked an emergency need of diagnostic kits, Personal Protective Equipment (PPE), ventilators, etc., in the United States. Hence, there is a pressing demand to fulfil the device shortages at the earliest, by maintaining the required safety and quality standards.