Medical devices directive

Home Medical devices Directive (93/42/EEC)

Directive

Medical devices Directive (93/42/EEC)

Scope

This Directive shall apply to medical devices and their accessories.

For the purposes of this Directive, accessories shall be treated as medical devices in their own right. Both medical devices and accessories shall hereinafter be termed devices.

EXCLUSIONS

This Directive shall not apply to:

In vitro diagnostic devices;
Active implantable devices covered by Directive 90/385/EEC;
Medicinal products covered by Directive 2001/83/EC. In deciding whether a product falls under that Directive or this Directive, particular account shall be taken of the principal mode of action of the product;
Cosmetic products covered by Directive 76/768/EEC (1);
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, with the exception of devices referred to in paragraph 4a;
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;
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.

DEFINITIONS

For the purposes of this Directive, the following definitions shall apply:

‘medical device’ means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and 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;
‘accessory’ means an article which whilst not being a device is intended specifically by its manufacturer to be used together with a device to enable it to be used in accordance with the use of the device intended by the manufacturer of the device;
‘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 alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:
- Concerning a physiological or pathological state, or
- Concerning a congenital abnormality, or
- To determine the safety and compatibility with potential recipients, or
- To monitor therapeutic measures.
Specimen receptacles are considered to be in vitro diagnostic medical devices. ‘Specimen receptacles’ are those devices, whether vacuum-type or not, specifically intended by their manufacturers for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination. Products for general laboratory use are not in vitro diagnostic medical devices unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination;

Description

The Medical Device Directive (Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, OJ No L 169/1 of 1993-07-12) is intended to harmonise the laws relating to medical devices within the European Union. The MD Directive is a 'New Approach' Directive and consequently in order for a manufacturer to legally place a medical device on the European market the requirements of the MD Directive have to be met. Manufacturers' products meeting 'harmonised standards' have a presumption of conformity to the Directive. Products conforming with the MD Directive must have a CE mark applied. The Directive was most recently reviewed and amended by the 2007/47/EC and a number of changes were made. Compliance with the revised directive became mandatory on 21 March 2010.

In 2017 a new Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices has been published in the Official Journal of the European Union on 5 May 2017, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. At the same time also a Regulation (EU) 2017/746 on in vitro diagnostic medical devices, repealing Directive 98/79/EC and Commission Decision 2010/227/EU, has been published.

Harmonised standards

EN 455-1:2000	Medical gloves for single use - Part 1: Requirements and testing for freedom from holes
EN 455-3:2006	Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
EN 455-4:2009	Medical gloves for single use - Part 4: Requirements and testing for shelf life determination
EN 556-1:2001	Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
EN 556-1:2001/AC:2006	Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
EN 556-2:2015	Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices
EN 1041:2008	Information supplied by the manufacturer of medical devices
EN 1060-4:2004	Non-invasive sphygmomanometers - Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers
EN ISO 1135-4:2011	Transfusion equipment for medical use - Part 4: Transfusion sets for single use (ISO 1135-4:2010)
EN 1618:1997	Catheters other than intravascular catheters - Test methods for common properties
Show all the standards...

EN 455-1:2000 Medical gloves for single use - Part 1: Requirements and testing for freedom from holes
EN 455-3:2006 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
EN 455-4:2009 Medical gloves for single use - Part 4: Requirements and testing for shelf life determination
EN 556-1:2001 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Par...
EN 556-1:2001/AC:2006 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Par...
EN 556-2:2015 Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Pa...
EN 1041:2008 Information supplied by the manufacturer of medical devices
EN 1060-4:2004 Non-invasive sphygmomanometers - Part 4: Test procedures to determine the overall system accuracy of...
EN ISO 1135-4:2011 Transfusion equipment for medical use - Part 4: Transfusion sets for single use (ISO 1135-4:2010)
EN 1618:1997 Catheters other than intravascular catheters - Test methods for common properties
Show all the standards...