# Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices, Division 2

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

The solutions adopted by the manufacturer for the design and construction of the devices must conform to safety principles, taking account of the generally acknowledged state of the art.
In selecting the most appropriate solutions, the manufacturer must apply the following principles in the following order:
eliminate or reduce risks as far as possible (inherently safe design and construction),
where appropriate take adequate protection measures in relation to risks that cannot be eliminated,
inform users of the residual risks due to any shortcomings of the protection measures adopted.

---
Source: https://www.legislation.gov.uk/eudr/1998/79/annex/I/division/A/division/2 (the official version)
Page: https://openlegislation.uk/eu-directive-1998-79/annex-I/division-A/division-2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.