Medical Device Directive | MDD93/42/ECC
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 March 21, 2010.
Medical devices may be classified as Class I, Class IIa, IIb and III, with Class III covering the highest risk products. Medical devices are classified according to two criteria, one being the level of invasiveness , and the the other one is about the accompanying level of risk to the patient.
♦ Class I Devices:
Class I Devices follow a Self-Declaration of Conformity route, unless the device is sold as sterile (Class Is) or has a measurement function (Class Im.) In these cases, the involvement of a Notified Body is required.
♦ Class IIa and IIb Devices:
Class IIa and IIb Devices require the services of a Notified Body to approve the Declaration of Conformity through a conformity assessment.
♦ Class III Devices:
Class III Devices represent the highest risk and are usually evaluated by a specialist team of assessors within the notified body.
Some factors you should take under consideration are:
• intended to be in continuous use
• invasive or surgically invasive,
• whether or not the device contains a substance.