COUNCIL DIRECTIVE 93/42/EEC of 14 June concerning medical devices. THE COUNCIL OF THE EUROPEAN COMMUNITIES,. Having regard to the. COUNCIL DIRECTIVE 93/42/EEC of 14 June concerning medical devices. ( OJ L , , p. 1). Amended by: Official Journal. No. 93/42/EEC concerning medical devices3 (MDD), the Council Directive .eu/ LexUriServ/raudone.info?uri=OJ:Len:PDF.
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MDD 93/42/ EEC in PDF format (Status: June ). In Vitro Diagnostic Medical Device Directive 98/79/EC The IVD Directive was published in by the. Conformity with Medical Device Directive 93/42/EEC is mandatory all devices that fit raudone.info).) Risk Class I devices: Annex VII. Directive 93/42/EEC of the European Union (EU) (also known as the Medical Devices Directive - MDD) details the Essential Requirements manufacturers and .
Legislation Collectively known as the Medical Device Directive MDD , this core legal framework consists of three directives that regulate the safety and marketing of medical devices in Europe and came into effect in the s. It is seen as a declaration by the manufacturer that the product meets all the appropriate provisions of the relevant legislation including those related to safety and, where required, has been assessed in accordance with these.
The CE marking of conformity, as shown in Annex XII, must appear in a visible, legible and indelible form on the device or its sterile pack, where practicable and appropriate, and on the instructions for use. Where applicable, the CE marking must also appear on the sales packaging.
It shall be accompanied by the identification number of the notified body responsible for implementation of the procedures set out in Annexes II, IV, V and VI. It is prohibited to affix marks or inscriptions which are likely to mislead third parties with regard to the meaning or the graphics of the CE marking. Any other mark may be affixed to the device, to the packaging or to the instruction leaflet accompanying the device, provided that the visibility and legibility of the CE marking is not thereby reduced.
This includes those related to safety and it shows that, where required, the device has been assessed in accordance with the appropriate procedures. CA's exist in each European Member State and are nominated by each government to monitor and ensure compliance with its provisions of the MDD. The CA designates a NB to ensure that conformity assessment procedures are completed according to the relevant criteria.
The authorized representative, designated by the manufacturers, is legally responsible for compliance with the regulations and acts as the first point of contact for the EU authorities. For many of the common techniques and product types there exist harmonised standards, listed in the reference links below. While use of a harmonised standard is not always mandatory, it is highly recommended as it represents best practice and technical state of the art, which can be used as a presumption of conformity to the relevant part of the directive.
If a manufacturer chooses not to follow a harmonised standard, they must be able to demonstrate clearly how the product meets the relevant safety or performance requirements. Compliance Route The compliance routes available to be able to CE mark your device, in accordance with the Medical Devices Directive, depend on the classification of your device.
It is not practical or feasible to apply the most rigorous conformity assessment process to all types of devices. Instead a graduated level of control is applied which categorises devices based on the level of inherent risk or potential hazards. Correct classification is therefore critical before commencing a compliance assessment.
In these cases, the involvement of a Notified Body is required. Several different conformity assessment routes are available to the manufacturer, based on their preference and individual requirements. The most common approach is usually Annex II.
Medical Device Directive 93/42/EEC (MDD)
Once you have been issued with a certificate by the Notified Body, you may affix CE marking to your device and place it on the market.Connect with us. Medical devices, bearing the CE marking, are presumed to conform to the appropriate essential requirements, unless there is reason to believe otherwise.
Notified Body The organization which will check whether the appropriate conformity assessment procedures have been followed is known as the Notified Body. It is a certification organization which the Competent Authority, of a Member State designates to carry out one or more of the conformity assessment procedures described in the annexes of the Directives.
It is a certification organization which the Competent Authority, of a Member State designates to carry out one or more of the conformity assessment procedures described in the annexes of the Directives.
The authorized representative, designated by the manufacturers, is legally responsible for compliance with the regulations and acts as the first point of contact for the EU authorities.
These will appear in the Official Journal of the European Communities. Location Search.