NIST GCR 01-815
A Guide to the EU Medical Device Directive
The Medical Device Directive 1 2 3
Directive 93/42/EEC
Applicable since June 1993 and mandatory since June 1998
To Be Considered:
The Medical Device Directive (MDD) is not applicable to the following products:
- In vitro diagnostics (covered by Directive 98/79/EEC)(See NIST GCR 01- 817).
- Active Implantable Medical Devices (covered by Directive 90/385/EEC) (See NIST GCR 01-816).
- Medicinal Products (covered by Directive 65/65/EEC).
- Cosmetic Products (covered by Directive 76/768/EEC).
- Devices intended for use in clinical investigation and custom-made medical devices must satisfy the requirements of the Medical Device Directive but do not need to affix the CE Marking. (See Annex VIII and Annex X of the Directive).
Other exceptions (See NIST SP 951 A Guide to EU Standards and Conformity Assessment, Page 19).
The electrical and electromagnetic safety aspects of medical devices are covered in the MDD.
Where a medical device is intended to administer a substance defined as a medicinal product within the meaning of Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products(6), as last amended by Directive 87/21/EEC(7), that substance shall be subject to the system of marketing authorization provided for in that Directive.
Where a medical device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product within the meaning of Article 1 of Directive 65/65/EEC, that device must be evaluated and authorized in accordance with the provisions of this Directive.
1 A medical device is: "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 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 which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means."
2 Readers of this report may wish to refer to NIST SP 951 A Guide to EU Standards and Conformity Assessment, which is available on NIST's website at: http://ts.nist.gov/ts/htdocs/210/gsig/cainfo.htm.
3 For additional information on active implantable medical devices and in vitro diagnostic devices , see NIST GCR 01-816 A Guide to the EU Active Implantable Medical Device Directive and NIST 01-817 A Guide to the EU In Vitro Diagnostic Directive.
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