# Council Directive of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (90/385/EEC), Division 1.1.1: Either a critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device where:

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

there is demonstration of equivalence of the device to the device to which the data relates and,
the data adequately demonstrate compliance with the relevant essential requirements.

---
Source: https://www.legislation.gov.uk/eudr/1990/385/annex/7/division/1/division/1.1/division/1.1.1 (the official version)
Page: https://openlegislation.uk/eu-directive-1990-385/annex-7/division-1/division-1.1/division-1.1.1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.