# Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices, Division 6.1

Extent: E+W+S+N.I.

Devices incorporating electronic programmable systems, including software, must be designed to ensure the repeatability, reliability and performance of these systems according to the intended use.

---
Source: https://www.legislation.gov.uk/eudr/1998/79/annex/I/division/B/division/6/division/6.1 (the official version)
Page: https://openlegislation.uk/eu-directive-1998-79/annex-I/division-B/division-6/division-6.1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.