# 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

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

The devices must be designed and manufactured in such a way that, when implanted under the conditions and for the purposes laid down, their use does not compromise the clinical condition or the safety of patients. They must not present any risk to the persons implanting them or, where applicable, to other persons.

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