Regulatory framework

Book with stethoscope © Jeffrey Horler - Fotolia

Legislation

Based on the New Approach, rules relating to the safety and performance of medical devices were harmonised in the EU in the 1990s. The core legal framework consists of 3 directives: Directive 90/385/EECpdf [158 KB] regarding active implantable medical devices, Directive 93/42/EECpdf [265 KB] regarding medical devices and Directive 98/79/EC [199 KB] regarding in vitro diagnostic medical devices. They aim at ensuring a high level of protection of human health and safety and the good functioning of the Single Market. These 3 main directives have been supplemented over time by several modifying and implementing directives, including the last technical revision brought about by Directive 2007/47/ECpdf [185 KB] .

Implementing measures

The Commission adopted several implementing measures based on the Medical Devices Directives. These measures concern medical devices manufactured utilising tissues of animal origin, the classification of certain medical devices and Common Technical Specifications for IVDs listed in Annex II of the IVD Directive.

Guidance

In addition, legally non-binding Guidance documents MEDDEV, consensus statements and interpretative documents pursue the objective of ensuring uniform application of the relevant provisions of the directives within the EU.

Revision of the regulatory framework

On 26 September 2012, the European Commission adopted a Proposal for a Regulation of the European Parliament and of the Council on medical devices and a Proposal for a Regulation of the European Parliament and of the Council on in vitro diagnostic medical devices which will, once adopted by the European Parliament and by the Council, replace the existing three medical devices directives. The texts of the proposals and other related documents are available here.