In order to satisfy the legal requirements laid down in Directive 90/385/EEC, in Directive 93/42/EEC and in Directive 98/79/EC, notified bodies should verify, where relevant, the fulfilment of the essential safety and health requirements contained in Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC , of the requirements contained in Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices a ...[+++]nd medical devices manufactured utilising tissues of animal origin and of the common technical specifications for in vitro diagnostic medical devices laid down in Commission Decision 2002/364/EC of 7 May 2002 on common technical specifications for in vitro diagnostic medical devices

Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices , Council Directive 93/42/EEC of 14 June 1993 concerning medical devices , and Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices , contain certain provisions with regard to the audits, assessments and unannounced audits performed by notified bodies in the field of medical devices.

In accordance with Article 60(2) of Regulation (EC) No 1907/2006, the Commission should not consider, when granting authorisations, the human health risks associated with the use of substances in medical devices regulated by Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices , Council Directive 93/42/EEC of 14 June 1993 concerning medical devices , or Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices .

Community legislation on the manufacture of derived products intended for use as cosmetic products, medicinal products or medical devices comprises a comprehensive framework for the placing on the market of such products: Council Directive 76/768/EEC of 27 July 1976 on the approximation of laws of the Member States relating to cosmetic products , Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use , Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Commun ...[+++]ity code relating to veterinary medicinal products , Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices , Council Directive 93/42/EEC of 14 June 1993 concerning medical devices and Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (the specific Directives).

The proposed directive has to be altered in order to render more stringent the definition of medical devices. This would make it more difficult to have medication registered as medical devices.

(1) In addition to being directed at medical devices for in vitro diagnosis, the Commission proposal sought to amend Council Directive 93/42/EEC of 14 June 1993 concerning medical devices(4) in order to extend its scope to medical devices manufactured by using non-viable tissues or substances of human origin derived from those tissues.