How are Near-patient Testing Devices Regulated under EU IVDR?
2 min read

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.

Article 2 of the EU IVDR defines NPT as a device intended to perform tests outside the laboratory environment but is not self-testing device. These tests are generally performed near to/side of the patient by a healthcare professional. NPT is also called Point-of-care Testing (POCT).

Like any other IVDs, NPT products are also required to apply for conformity assessment and obtain a CE marking. However, for NPTs, there are additional requirements in IVDR, one providing more substantial evidence for the design and performance safety.

The most challenging aspect faced by the manufacturers is product quality assurance and meeting the accredited requirements. NPTs are usually for users outside of the laboratory environment. Because these users lack the necessary skills, errors may occur, tainting the product's quality. Therefore, IVDR clearly states that NPT products are required to ensure that the product is being designed and manufactured, accounting for the users' skills. The information supplied with the device shall make clear the required training, knowledge, and skills for the intended users.

Also, the information and instructions supplied with the device should be easily understandable to the user to correctly interpret the result provided by the device and avoid misleading information. The manufacturers should also ensure that, wherever feasible, they incorporate a procedure for the user that can verify the functioning of the device at the time of use. The manufacturer should also reduce the risk of error as much as possible while handling the device, specimen (if applicable), and the analysis of the results as well by the user. If the tests are intended for use in a wide range of environments, manufacturers must demonstrate that the test can be used reliably in the relevant environments (for example, patient homes, emergency units, and ambulances). 

Some of the standards that are applicable to NPTs are ISO 22870:2016, “Point-of-care testing (POCT — Requirements for quality and competence” used in conjunction with ISO 15189:2022, and “Medical laboratories — Requirements for quality and competence.”

Further, the NPTs need to comply with some additional labeling requirements. For instance, NPTs are required to affix the below symbol on the device.

While registering in the EUDAMED, the manufacturers are required to specifically mention that the device falls under the NPT category.

Moreover, the non-paper format of Instruction For Use (eIFU) is not applicable for the NPTs, as well as, in the case of multiple devices, multiple copies of IFUs are to be provided even though it’s the same user or location.

From the perspective of conformity assessment, the entire process for NPT devices is the same as for other devices. But in the technical documentation, NPTs are required to incorporate design details justifying their device scope. While lodging the application for conformity assessment with notified bodies, the NPTs must include test reports, results of studies conducted with intended users, and data demonstrating the device's handling suitability concerning its intended purpose.

NPTs must also implement a post-market surveillance system and periodically update the Periodic Safety Update Report (PSUR). Post-market Performance Follow-up (PMPF) is also to be implemented for the NPTs.

Thus, with the emerging trend for the adoption of NPTs in Europe and with the implementation of IVDR, NPT manufacturers are entailed to brace up. The limited Notified Bodies for IVDs can delay the transitioning process, thereby leading to a delay in the launch market. Therefore, it is quite important for NPT manufacturers to be aware of the additional requirements for these devices.

We at Freyr provide end-to-end support for CE certification of NPT devices. Consult our Regulatory experts today!