Article 3
The active implantable medical devices referred to in Article 1(2)(c), (d) and (e), hereinafter referred to as
‘
devices
’
, shall satisfy the essential requirements set out in Annex 1 which apply to them, account being taken of the intended purpose of the devices concerned.
Where a relevant hazard exists, devices which are also machinery within the meaning of Article 2(a) of Directive 2006/42/EC of the European Parliament and of the Council of
17 May 2006
on machinery
shall also meet the essential health and safety requirements set out in Annex I to that Directive to the extent to which those essential health and safety requirements are more specific than the essential requirements set out in Annex 1 to this Directive.
OJ L 157, 9.6.2006, p. 24 .
Substituted by Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market (Text with EEA relevance).