Medical Devices Directive 93/42/EEC, Technical Information from BM Polyco Limited

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	Medical Devices Directive 93/42/EEC

The Medical Devices Directive came into force on 1 January 1995 and had a transition period which ended on 13 June 1998. Therefore, all medical devices placed in the market following 13 June 1998 must be CE marked and proven to comply with relevant product standards.

The UK Competent Authority

The Medical Devices Directive requires medical product manufacturers to either register with a competent authority or have their products certified by a Notified Body. The decision to register or certify is based upon the classification of the product as a medical device.

Classification of Medical Devices

The Medical Devices Directive lists four different classifications of medical device which range in risk to the patient from low risk to high risk. These classifications are:

Class I, Class IIa, Class IIb and Class III

In addition, Class I devices may be non-sterile, sterile or measuring

BM Polyco products fall into one of the first two classes;

Non-sterile examination gloves are Class I
Non-sterile swabs are Class I
Wound dressings are Class I (if they do not manage the wound environment)
Clinical thermometers are Class I (with a measuring function)
Sterile syringes and syringe needles are Class I Sterile (this does not apply to cannula)
Sterile surgeons gowns are Class I Sterile
Sterile examination gloves are Class I Sterile
Sterile surgical gloves are Class IIA
Sterile swabs are Class IIa
Sterile scalpel blades and pre-assembled sterile scalpels are Class IIa
Electronic Thermometers are class IIa

Class I products may be self certified, in which case the manufacturer prepares Technical Documentation to prove that their products meet the essential requirements of the Directive. Tests according to harmonised European standards may be used to prove compliance. Where harmonised European standards do not exist tests according to non-harmonised European standards, international standards, or certain national standards can be used. ISO 10993, biological evaluation of medical devices, may be used to determine the compliance of the product with the essential requirements of the directive with regard to product safety. Also, the Risk Assessment procedure defined in EN1441 or EN ISO 14971 may be followed in order to judge the safety of the product and the acceptability of any risks associated with its use. A declaration of conformity with the Directive is prepared and the manufacturer registers with the competent authority. In the UK, the competent authority is the Medicines and Healthcare Products Regulatory Agency (MHRA).

Class I sterile products require all of the above steps, but in addition the intervention of a Notified Body is required to verify the validation of the sterilisation process. Medical gloves are usually sterilised by either ethylene oxide or irradiation. EN550 specifies the validation and routine control of ethylene oxide sterilisation, EN552 specifies the validation and routine control of sterilisation by irradiation. In each case, medical gloves must comply with EN556, requirements for terminally-sterilised devices to be labelled sterile. The above standards provide for parametric release of sterile products which means that bioburden must be controlled within defined limits during production such that specified sterilisation conditions will reduce the number of living micro-organisms to less than one in 1 x 106 sterilised units. EN550 and EN552 specify that bioburden be estimated by the methods defined in the EN1174 series of standards. The sterilisation standards also require the sterilisation process to comply with the Quality System requirements of either EN46001 or EN46002 (application of EN29001/EN29002 to the manufacture of medical devices).

Class I measuring products also require all of the above steps and the intervention of a Notified Body, to verify that the accuracy and stability of the product.

Class IIa products, do not need to be registered with a competent authority, but otherwise require all of the above steps. Products are certified through a Notified Body who may require the application of EN46001/EN46002 (or equivalent) to the manufacturing process.

Note: at the time of writing, a new draft standard ISO13485 is in preparation which when published will supersede EN46001/EN46002.

CE Marking

Class I gloves are marked with the CE Marking:

Class I sterile, Class I measuring and Class IIa products carry the approval number of the Notified Body involved in the product certification and/or the validation of the sterilisation or measuring process. In the case of BM Polyco, the Notified Body involved in the certification of our sterile medical products is Lloyds Register Quality Assurance (LRQA) and the number 0088 appears after the CE marking.