Medical devices may be classified as Class I, Class IIa, IIb and III, with Class III covering the highest risk products.
The higher the classification the greater the level of assessment required by Notified Bodies. See also later sections on Conformity Assessment and Notified Bodies.
Classification of a medical device will depend upon a series of factors, including:
- how long the device is intended to be in continuous use
- whether or not the device is invasive or surgically invasive,
- whether the device is implantable or active
- whether or not the device contains a substance, which in its own right is considered to be a medicinal substance and has action ancillary to that of the device.
The classification rules are set out in Annex IX of the directive. This annex includes definitions of the terminology used in the classification rules.
Guidance documents on the classification of medical devices have been published by both MHRA (Bulletin 10) and the European Commission (MEDDEV 2.4/1), available in two parts.
Medical Devices (Amendment) Regulations 2007 to transpose the Reclassification Directive 2005/50/EC into UK law
The Medical Devices (Amendment) Regulations 2007 (S.I. No 400) which transpose into UK law the Directive 2005/50/EC which reclassifies hip, knee and shoulder joint replacements as class III medical devices was made on 15 February 2007 and laid before parliament on 16 February 2007. Certain parts of the Regulations will come into force on 10 March 2007.
The Directive fully comes into force on 1 September 2007 and the remainder of Regulations will come into force on this date.
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The Medical Devices (Amendment) Regulations 2007 No 400 (external link)
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Commission Directive 2005/50/EC of 11 August 2005 on the reclassification of hip, knee and shoulder replacements in the framework of Council Directive 93/42/EEC concerning medical devices
(41Kb)
Placing these joint replacements in this highest risk category increases the level of scrutiny the Notified Body (an independent third party certification body) will have to undertake before issuing the manufacturer with an EC Certificate of Conformity. Under these proposals the Notified Bodies will be required to also verify that each type of hip, knee and shoulder joint replacement placed on the market meets the requirements.
The Commission Directive 2005/50/EC provides for a transitional period for hip, knee and shoulder joint replacements already assessed or subject to different conformity assessment routes.
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Guidance on the Commission Directive on the reclassification of total hip, knee and shoulder joint replacement (53Kb)
Guidance on the Directive has also been produced by the European Commission:
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Guidance document on Directive 2005/50/EC (external link)
