Near-Patient Testing (Point-of-Care Testing)

The In-vitro Diagnostic Medical Device Regulation 2017/746/EU (IVDR) is fully applicable from the 26th of May 2022. A medical device for near-patient testing (NPT) is defined under Article 2 of the IVDR as any device that is not intended for self-testing but is intended to perform testing outside a laboratory environment, generally near to, or at the side of the patient by a health professional. This is sometimes referred to as point-of-care testing. An NPT device operated by a health professional and used in either hospital or primary care/community settings is included.

Many of the requirements for NPT devices have been strengthened under the IVDR to ensure the devices are appropriate for their intended use and suitable for their intended use environment. Manufacturers must ensure that NPT devices can be clearly identified and must provide clarity on the level of training, qualifications and/or experience required by the user.

In April 2021, the National NPT Consultative Group released an updated version of the Irish National Near-Patient Testing Guidelines. The guideline includes a chapter on regulatory requirements for NPT devices and the role of the HPRA.