The European Commission has just published an Information pack for candidate laboratories in the context of European Union reference laboratories (EURLs) in the field of in vitro diagnostic medical devices.
This is a very important document for the reference laboratories approach. The information pack covers:
– Introduction, including Class D, Conformity Assessment and Common Specifications.
– Legal framework, covering designation, tasks, financing and controls.
– Overall selection process, covering selection criteria and accreditation.
– Practical aspects of the selection process, with steps and application information
– Key resources
– Member States contacts.
In vitro diagnostic medical devices (IVDs) are tests intended for examination of human specimens for a medical purpose
. In the EU, there is dedicated legislation that manufacturers must follow to produce and sell such devices. This legislation is Regulation (EU) 2017/746. It was adopted by the European Parliament and by the Council in 2017 and entered into application on 26 May 2022, replacing Directive 98/79/EC. The Regulation has significantly reinforced the regulatory framework for IVDs compared to the Directive. For example, it introduced a new risk-based classification system for IVDs (class A-D in order of increasing risk), more detailed and stringent rules on the evaluation of device performance, and greater involvement of independent conformity assessment bodies (‘notified bodies’ – please see the schematic below). You can read more about the new Regulation here.