Medical Devices Directive

English: MDD (Medical Device Directive )

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

It is the most important regulatory instrument for the detection of safety and medical-technical performance of medical devices in the European Economic Area. It was last modified in 2007 on the amendment of Directive 2007/47/EC in large parts. These changes were national legal effect on 21 March 2010 in the EU.

As with 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 service only if they and duly supplied and properly installed, maintained their Intended appropriate use meet the requirements of this Directive. "

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

The implementation of the Medical Device Directive into national law in each case carried out by national law, in Germany and Austria by the German Medical Devices Act (Act on Medical Devices). Switzerland, although not a member of the European Union, nor the European Economic Area, (Federal Law on Medicinal Products and Medical Devices) refers Remedies Act also to this Directive.

Medical devices within the meaning of Directive

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 the proper functioning of the medical device, intended by the manufacturer to be used for human beings for the purpose of:

  • Diagnosis, prevention, monitoring, treatment or alleviation of disease;
  • Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap;
  • Investigation, replacement or modification of the anatomy or of a physiological process;
  • Control of conception,

And its principal intended action in or on the human body by pharmacological, immunological or metabolic means nor is reached, the operation of which may be assisted by such means. For the purposes of this Directive, accessories shall be treated as medical devices; other products are defined as medical devices are:

  • Customized products according to medical requirement for certain patients,
  • For clinical trials in humans certain products.

Exempted Medical Devices

The following medicine products are not subject to Directive 93/42/EC:

  • Active implantable medical devices ( eg pacemakers ) are subject to the Medical Devices Directive 90/385/EEC
  • In vitro diagnostic medical devices as subject to Directive 98/79/EC
  • Fixed non-reusable units with a drug ( pharmaceutical kit )
  • National exceptions in individual countries

The issue of delimitation of different product groups is treated in the article product differentiation.

Amending Directive 2007/47/EC

On 29 March 2007 the European Parliament approved the proposal amending Council Directives 90/385/EEC and 93/42/EEC and Directive 98/8/EC as regards the revision of the Medical Devices Directives ( COM ( 2005) 0681 - C6-0006/2006 - 2005 / 0263 (COD)) agreed.

The publication of the amendment to the Directives 90/385/EEC, 93/42/EEC and 98/8/EC took place on 5 September 2007 with Directive 2007/47/EC. The Directive entered into force on 25 September 2007. The respective national implementation of the Amending Directive in the EU Member States had to take place by December 21, 2008. In Germany, the amending law of 29 July 2009 entered into force on 1 August 2009 and 1 January 2013. On 21 March 2010, the national changes to EU Directive 2007/47/EC across the EU entered into force and apply ever since.

Amendment of Directive

On September 26, 2012, the European Commission published on its website http://ec.europa.eu/health/medical-devices/documents/revision/index_en.htm proposals for a

" Regulation of the European Parliament and of the Council concerning medical products and amending Directive 2001/83/EC, Regulation ( EC) No 178/ 2002 and Regulation (EC ) No 1223 /2009", dated 26 September 2012 COM (2012) 542 final, 2012/0266 ( COD) "

And a

" Regulation of the European Parliament and of the Council on in vitro diagnostic medical devices ", dated 26 September 2012 COM (2012 ) 541 final; 2012/0267 ( COD)

(initially only ) in English, German and French language versions.

The work of the committees of the EU Council began in late October 2012.

In contrast to the situation today in the form of directives of the European Commission re-regulation provides for regulations. This means that the implementation is omitted by national laws, for valid EU regulations put in all Member States applicable law dar.

In vitro diagnostics
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