Medical devices Regulations Part 1

Panel: FDA Needs A Reboot On Regulation Of Medical Devices : Shots

Council Directive 93/42/EEC of 14 June 1993 concerning medical devices is one of three medical device EU directives and in Germany and Austria briefly referred to as Medical Device Directive. International one speaks of the Directive as a Medical Device Directive (MDD) 93/42/EEC or Directive.

It is the most important regulatory instrument to demonstrate the safety and performance of medical technology medical products in the European Economic Area . She was last modified in 2007 to amend Directive 2007/47/EC in large parts. These changes were adopted on 21 March 2010 the EU national legal effect.

Like all European directives , the primary objective of the Directive, to ensure the free movement of goods. This is Article 2 of Directive 93/42/EC, which requires that 'Member States shall take all necessary measures to ensure that products placed on the market and / or may be put into operation if and when duly supplied and properly installed, maintained their purpose of determining the appropriate use meet the requirements of this Directive. "

The other articles deal with the administrative implementation and refer to other legal relationships.

The implementation of the Medical Device Directive in each national law is organized by national law in Germany and Austria by the Medical Products Act (Act on Medical Devices). The Switzerland , although not a member of the European Union or the European Economic Area, refers Remedies Act (Federal Law on Medicinal Products and Medical Devices) also to this Directive.

[ Bearbeiten ] Medical devices as defined in Directive [ Edit ]

Medical devices within the meaning of the Directive, all instruments used alone or in combination, apparatus, appliance, material or other article, including the software necessary for its proper functioning of the medical device intended by the manufacturer to be used for human beings for the purpose of:


Basic data of the Directive
Title: Directive 93/42/EC of the European Parliament and of the Council of 14 June 1993 concerning medical devices
Short title ::
(Not official)
Medical Devices Directive English: MDD (Medical Device Directive)

Legal nature: Directive Scope: European Union Release: OJ. EC No. L 169, 12.7.1993 Adoption: 12th July 1993 Into national law
implemented by:
1 July 1994 Implemented by: Medical Devices Act (Germany) on 2 August 1994 Last modified by: Directive 2007/47/EC, OJ. L 247 of 21 September 2007 pp. 21-55 Entry into force of
last modification:
25th September 2007

GMP Training Package Library Edition: The FDA Regulations on Part 11, Electronic Records and Electronic Signatures, for Pharmaceutical, Medical Device, Food, and Cosmetics Manufacturing
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2010-01-18 11:40:06 by sweet_simplicitys

ACLU challenges US laptop border searches

Privacy campaigners are continuing a legal challenge against random laptop border searches by US customs amid concerns there may be a racial bias in those delayed and inconvenienced by stop and search powers introduced as part of the war on terror.
The ACLU also argues that searches of mobile phones by US border agents in the absence of any reason to be suspicious also pose a unwarranted invasion of privacy while delivering few tangible benefits.
Customs and Border Protection agents searched over 1,500 electronic devices at the US border over a period of nine months between October 2008 and June 2009, according to documents obtained by the ACLU as part of a Freedom of Information Act lawsuit and published on Thursday

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