General Safety and Performance Requirements

The heart of the European Union (EU) regulation of in vitro diagnostic medical devices (IVDs) lies in allowing market access to IVDs that offer clinical benefit, and are safe to the patient, the user of the IVD and others (such as service technicians).

The regulation is written so that requirements ensuring a high level of protection of health and safety are, where appropriate, must be fulfilled.

Under the EU IVD Directive 98 /79 / EC, manufacturers have been required to comply with the essential requirements (ERs).