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The Medical Devices Directive Summary This Medical Devices Directive is a CE Marking Directive which, along with two associated directives, the Active Implantable Medical Devices Directive and the In Vitro Diagnostic Devices Directive, cover all medical equipment. This directive includes equipment intended by the manufacturer to be used to diagnose, prevent, monitor, treat, alleviate, compensate for and/or control a disease, injury, handicap, physiological process or conception. Contents Purpose The Medical Devices Directive was enacted to provide for a harmonised regulatory environment for all medical devices sold within the European Economic Area. All products which fall within the scope of the Directive must meet certain essential safety and administrative requirements and are to be CE marked to show that they comply. Such products may then be freely sold throughout the EEA without being subject to additional national regulations. The Medical Devices Directive is one of a suite of three directives which together cover all medical equipment. The associated directives are the Active Implantable Medical Devices Directive (AIMDD) and the In Vitro Diagnostic Devices Directive (IVDD). The IVDD has not yet been enacted by the European Parliament, but a proposed text of the Directive was published in 1997 and it is expected that the IVDD will be fully implemented by the end of 2001.
Custom-made devices and those intended exclusively for the purposes of clinical trials are excluded from certain of the Directive's administrative provisions, although they must still meet the essential safety requirements and may only be applied to patients by clinical specialists. Clearly the scope of the Directive is extremely wide and potentially there is overlap with other Directives. However, the MDD includes provisions for all relevant hazards, including mechanical and electrical safety and provisions for electromagnetic compatibility. Devices which fall within the scope of the MDD, the AIMDD and the IVDD are generally excluded from the scope of the other Directives. However, equipment which may have an application which is not exclusively medical will usually have to comply with the other Directives.
Equipment which (in the UK at least) is not considered to fall within the scope of the MDD includes:
An example of equipment which may or may not be within the scope of the MDD depending on the purpose for which they are marketed are protective gloves - those intended for use in direct contact with patients will be considered as medical devices while those used (for instance) in a medical laboratory are considered to be PPE. While in theory article 100a of the Treaty of Rome (now actually article 95 of the Treaty of Amsterdam) should ensure that legislation governing CE marked products is the same across the whole of the EEA, the reality is that the regulations implementing and enforcing the Directives are drafted individually in each member state and do sometimes interpret the Directives differently. This can mean that different CE marking requirements need to be met in different countries. A good example of this in relation to medical devices can be found in connection with medical gas pipelines and accessories. In the UK these products are treated by the Competent Authority as part of the infra-structure of the medical institution, much the same as heating or water pipes, and as such they do not need CE marking under the Directive. Certain other EEA countries, however, do regard them as medical device accessories (as they are connected to medical devices) and do require them to be CE marked. With complex apparatus such as this, it is important to check the interpretation of the Directive in every country in which a product is to be marketed. Complying with the regulations of one Member State does not automatically guarantee compliance in others, and it does not ensure against interference from other Competent Authorities or even from prosecution. The directive applies different administrative requirements to devices depending on the risk which they present to the user. There are four classifications:
Once it has been decided that a device falls within the scope of the Medical Devices Directive, the actual classification of an appliance is determined by a series of rules which are laid out in annex IV to the Directive. Essentially these start by saying that anything which is not covered by one of the other rules is a class I device, and then go on to give more detailed rules for the classification of other equipment. Typical factors upon which the rules decide are whether the device is intended for long term or short term use, whether it involves the use of associated pharmaceuticals and chemicals, whether it is invasive in normal bodily orifices or via surgical insertion, and whether it operates by the exchange of energy with the body. Definitions of terms used to describe these factors are also included in the annex. Supplier registration: The essential requirements of the Directive apply to all medical devices. The most basic requirement is for the manufacturers or their authorised representative in the EU to register with the appropriate agency in the country in which they are based. This makes the MDD different from all the other New Approach Directives in that there is actually a specific provision which requires manufacturers and suppliers of devices to appoint a representative within the EU, and for that representative to be registered with an appropriate government agency. In addition to Registration, manufacturers (or their agents) must typically
Annex 1 of the Directive lays down a series of essential requirements for the design of medical devices. These include (among others):
The details of these essential requirements are laid out in a series of standards which have been (or are being) developed to meet the requirements of the Directive. Additionally, the different classifications of device are subject to different conformity regimes, as follows:
One of the other provisions which distinguishes the Medical Device Directives from the other New Approach Directives is that they establish standing committees to consider the development and application of standards produced in support of the essential requirements, and to consider (in effect) 'matters arising' regarding the safety of devices within the scope of the Directives. The Directive was brought into force with effect from 1 January 1995. Transitional arrangements permitted equipment which complied with national regulations to be sold until 14 June 1998 after which the MDD will be fully in force and all equipment within its scope must comply. The enforcement authority ("competent authority") in the UK is the Medical Devices Agency. For further advice please contact us at Conformance where we will be pleased to discuss your needs.
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