legislation-profile

In Vitro Diagnostic Medical Devices Directive

EU. Hazardous Substances for Purposes of Art. 3 & Annex I (Essential Requirements), Directive 98/79/EC on In Vitro Diagnostic Medical Devices

Scope

Directive shall apply to in vitro diagnostic medical devices and their accessories. For the purposes of this directive the following definitions apply: 'medical device' means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application, intended by the manufacturer to be used for human beings for the purposes as defined in Art. 2 (a). 'in vitro diagnostic medical device' means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used along or in combination as defined in Art. 2 (b).

Exemptions

This directive shall not apply to devices manufactured and used only within the same health institution and on the premises of their manufacture or used on premises in the intermediate vicinity without having been transferred to another legal entity. (Art. 1 (5)).

Regulatory activities

Conformity assessment procedures (Art. 9): For all devices other than those covered by Annex II and devices for performance evaluation, the manufacturer shall, in order to affix the CE marking, follow the procedure referred to in Annex III and draw up the EC declaration of conformity required before placing the devices on the market. Registration of manufacturers and devices (Art. 10): Any manufacturer who places devices on the market under his own name shall notify the competent authorities of the MS in which he has his registered place of business. The notification will also include any new devices.

Relevant product types

Not applicable

Reference documents

Yes Directive 93/42/EEC Directive 90/385/EEC Directive 98/34/EC Directive 67/548/EEC Directive 88/379/EEC

Obligations based on CLP hazard class

Yes Annex I - essential requirements, point 8.3.: In case of devices containing or a preparation which may be considered as being dangerous, relevant danger symbols and labelling requirements shall apply.

Obligations based on properties of concerns

No

EU-level occupational exposure limits

Not applicable

EU-level emission limit values

Not applicable

Substance-centric data source(s) at the EU level

Yes European databank

Industry submission system in place

Not specified According to the Directive, regulatory data submitted by manufacturers shall be stored in the European databank accessible by MS Competent authorities. Data shall be forwarded in a standardised format.

Format for industry submission

Not applicable

Owner

DG GROW

Update process

DG GROW

Amendments

Corrigendum, OJ L 022, 29.1.1999, p. 75(1998/79) Corrigendum, OJ L 006, 10.1.2002, p. 70(1998/79) REGULATION (EC) No 1882/2003 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 29 September 2003 REGULATION (EC) No 596/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 18 June 2009 COMMISSION DIRECTIVE 2011/100/EU Text with EEA relevance of 20 December 2011

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