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Regulatory framework

Regulatory framework

Current Legislation

Regulations relating to the safety and performance of medical devices in the EU were harmonised in the 1990s, following the New Approach on legislative principles. The core legal framework consists of three directives:

They aim of these Directives is to ensure a high level of protection for human health and safety and a good functioning of the Single Market. These three main directives have been supplemented over time by several modifying and implementing directives, including the last technical revision brought about by Directive 2007/47/EC.

The original Directives have been amended several times and a consolidated version is available.

List of amendments

 Active implantable medical devicesIn vitro diagnostic medical devicesMedical devices
Original directiveDirective 90/385Directive 98/79Directive 93/42
Amendment 1Directive 93/42Regulation 1882/2003Directive 98/79
Amendment 2Directive 93/68Regulation 596/2009Directive 2000/70
Amendment 3Regulation 1882/2003Directive 2011/100Directive 2001/104
Amendment 4Directive 2007/47 Regulation 1882/2003
Amendment 5  Directive 2007/47
Latest but one consolidated version20.11.2003 including amendment No. 307.08.2009 including amendment No. 220.11.2003 including amendment No. 4
Latest consolidated version11.10.2007 including amendment No. 411.01.2012 including amendment No. 311.01.2007 including amendment No. 5

Implementing Measures

The Commission adopted several implementing measures based on the Medical Devices Directives. These measures concern, among others, medical devices manufactured using tissues of animal origin, the classification of certain medical devices and Common Technical Specifications for In vitro diagnostics (IVDs)s, listed in Annex Ⅱof the IVD Directive.

See below key documents on recommendations, classification and other amending and implementing legislation:

Guidance

In addition, legally non-binding guidance documents, MEDDEVs, consensus statements and informative 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 i) medical devices and ii) in vitro diagnostic (IVD) medical devices. These regulations, once adopted, will replace the existing three medical devices directives.

The texts of the proposals and other related documents are available on the Revision page

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