legislation-profile

Medical Devices Directive

Council Directive 93/42/EEC of 14 June 1993 concerning medical devices

Scope

The Directive applies to medical devices and their accessories (both termed as 'devices'). For the purpose of the directive, 'medical device' means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination as defined in Article 2 of the directive.

Exemptions

The Directive shall not apply to: (a) in vitro diagnostic devices (b) active implantable devices covered by Directive 90/385/EEC (c) medical products covered by Directive 2001/83/EC (d) cosmetic products covered by Directive 76/768/EEC (e) human blood, blood products, plasma or blood cells of human origin or to devices which incorporate at the time of placing on the market such blood products, plasma or cells (f) transplants or tissues or cells of human origin nor to products incorporating or derived from tissues or cells of human origin, with the exception of devices referred to in paragraph 4a (g) transplants or tissues or cells of animal origin, unless a device is manufactured utilizing animal tissue which is rendered non-viable or non-viable products derived from animal tissue.

Regulatory activities

Registration of persons responsible for placing devices on the market (Art. 14)

Relevant product types

Not applicable

Reference documents

Yes Directive 90/385/EEC on active implantable diagnostic medical devices Directive 2001/83/EC on medical products Directive 76/768/EEC on cosmetic products (now Regulation on cosmetic products)

Obligations based on CLP hazard class

Yes Annex I - essential requirements, point 7.5. - labelling obligations if devices contains phthalates , which are classified as CMR of category 1A or 1B

Obligations based on properties of concerns

Yes Annex I - essential requirements, point 7.5. - labelling obligations if devices contains phthalates , which are classified as CMR of category 1A or 1B

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 database on medical devices (EUDAMED). Its purpose is to strengthen market surveillance and transparency in the field of medical devices, by providing national competent authorities with fast access to information. EUDAMED is a secure, web-based portal, which serves as a central repository for information exchanged between MS national competent authorities and the Commission. It is not publicly accessible.

Industry submission system in place

No

Format for industry submission

Not applicable For EUROMED database, data must be forwarded in a standardised format.

Owner

DG GROW

Update process

Responsible notification bodies; MS authorities With regard to standards (ISO) usually these are updated every five years (European standard organisation CEN/CENELEC is responsible organisation). However, it is up to MS authorities and Notified bodies to decide if a product needs to be compliant with these prescribed standards.

Amendments

DIRECTIVE 98/79/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27 October 1998 DIRECTIVE 2000/70/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 November 2000 DIRECTIVE 2001/104/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL Text with EEA relevance of 7 December 2001 REGULATION (EC) No 1882/2003 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 29 September 2003 DIRECTIVE 2007/47/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL Text with EEA relevance of 5 September 2007