Nearly 40 years have elapsed since the invention of the PCR, with its extremely sensitive
and specific ability to detect nucleic acids via in vitro enzyme-mediated amplification. In turn …

Abstract The EU In-Vitro Diagnostic Device Regulation (IVDR) aims for transparent risk-and
purpose-based validation of diagnostic devices, traceability of results to uniquely identified …

Since beginning of medical diagnostics, laboratory specialists have done an amazing job,
continuously improving quality, spectrum and speed of laboratory tests, currently …

In order to guarantee patient safety, medical laboratories around the world strive to provide
highest quality in the shortest amount of time. A major leap in quality improvement was …

In this issue of the Journal, two papers deal with a fundamental issue in the practice of
clinical laboratories, leading us to rethink the management of internal quality control (IQC) in …

The background to this debate is now well-known: an EU policy decision to tighten controls
on the devices and diagnostics sector led to the adoption of a regulation in 2017 with a …

Abstract On May 26th 2017 the European Parliament and the Council of The European
Union adopted the new regulation on in vitro diagnostic medical devices (IVDR)‐Regulation …

In vitro diagnostics (IVD) testing is a powerful tool for medical diagnosis, and patients 'safety
is guaranteed by a complex system of personnel qualification of the specialist in laboratory …

Molecular diagnostic tests enable rapid analysis of genomic and proteomic markers. These
tests are subject to diverging premarket access and postmarket surveillance requirements …

With the implementation of Regulation (European Union [EU]) 2017/746 on in vitro
diagnostic medical devices (IVDR), from May 26, 2022, onwards, the development and use …