European Medical Devices Directive

From a classification point of view, ocular endotamponades are classical medical devices. Their application inside the human eye requires, besides ultra-purity, special controls during the manufacturing as well as for the release of finished products. They must be non-toxic and sterile and have to meet the general requirements of the European Medical Device Directive (MDD). 

A number of regulators including those enforcing the European Medical Device Directive now prefer manufacturers to demonstrate conformity through compliance... 

The basis for the national or international standards (lEC, UL, VDE, MDD [the European Medical Device Directive]) is to reduce file risk of hazardous currents reaching the patient under normal conditions. Even under a single fault condition, patient safety shall be secured. 

The adoption of the European Medical Device Directive (MDD) in June of 1998 and the mandatory implementation of the CE label on all sterile medical devices marketed in the European Community have resulted in the compulsory use of expiration dates on all medical device packages. In Older to obtain the CE label, all the Essential Requirements of the directive must be met. The MDD states that the label must bear. . . where appropriate, an indication of the date by which the device should be used, in safety, expressed as the year and month. ... 

CE Mark. All medical textiles regarded as medical devices now placed on the market have to comply with the European Medical Devices Directive and bear the CE mark, demonstrating that they are fit for their intended purpose and meet the essential requirements of the Directive. If they are supplied sterile, then the manufacturer or suppher also needs to consult with a Notified Body. ... 

To define what we mean by a medical textile, it may be appropriate to use the same approach that has been established for a product qualifying as a medical device. Using this approach, n medical textile is defined as any textile product manufactured with the intention to be used to diagnose, prevent, monitor, treat or alleviate disease, to compensate an injury or handicap, to investigate, replace or modify the anatomy or a physiological process, or to control conception. This definition taken from the European Medical Device Directive (its U.S. counterpart is issued by the Food and Drug Association [FDA]) is made from a regulatory perspective and specifies what criteria medical devices need to fulfil to make them safe to use and make it possible to sort out... 

The European Medical Device Directive, http //ec.europa.eu/health/medical-devices/index en.htm. 

In response to ever-increasing innovation and development of medical textiles, medical textile performance testing is required during the manufacturing process. The test requirements developed by the European Medical Devices Directive are presented in this section. There are different classes of test methods and standards. However, the conformity with each test standard depends on the types and classes of the medical... 

Where there is a dosing device provided with the product, the dose reproducibility and accuracy should be demonstrated. Examples include dropper devices, dose-measuring devices, and pen injectors. The instructions for use should also be discussed for such devices and may be particularly important for devices such as two-chamber cartridges and the like containing suspension products. It might be necessary to discuss how dosing devices meet the relevant Essential Requirements of the Medical Device Directives with reference to appropriate and relevant harmonized and other European (EN) and International Standards Organization (ISO) standards. 

In Europe, prior to the CE mark, medical devices were registered in individual countries, each having a set of specific registration requirements. In June 1993, the Council of European Communities issued the medical device directive (MDD), which has been transposed into national laws throughout the EC. The purpose of adoption of the MDD was to allow the health care industry to benefit from the advantages of a single European market and allow products to circulate freely in the EC without additional technical constraints issued by the various member states. 

European medical device requirements are defined in EU Directive 93/42/EEC published in 1994. National legislation and regulatory authorities such as the U.K. Medicines and Healthcare products Regulatory Authority (MHRA) enforce this directive. Four classes of device are defined, each of which requires a visible CE marking of conformity. CE marking of conformity means that the manufacturer is satisfied that the medical device conforms to relevant EU Directives and that it is fit for purpose. Technical documentation supporting conformity related to automated devices includes ... 

The precise definition of a medical device varies depending on the regulatory framework under consideration and even interpretation by individual countries. Examples include the European Commission s Medical Device Directive (MDD) and that of the US Food and Drug Administration. Whilst in principle each country can... 

At this point it is worth mentioning how the ALARP approach to risk acceptability changes markedly when it comes to medical devices. For example. International Standard ISO 14971 [10] affords manufacturers the ability to justify risks on an ALARP basis. The European Commission Medical Device Directive (MDD) [11] cites ISO 14971 as a Harmonised Standard however the directive contains a number of Essential Requirements on risk acceptability which appear to conflict with ISO 14971. 

Two directives related to medical devices are the Medical Devices Directive (MDD), enacted in 1993 (mandatory as of June 15,1998), and the Active Implanted Medical Devices Directive (AlMDD), effective since 1995. Safety is the primary concern of this system, and as in the United States, there are three classes of risk. These risks are based on what and for how long the device touches, and its effects. Safety issues include electrical, mechanical, thermal, radiation, and labeling. Voluntary standards that address these issues are formulated by the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC). 

The Council of the European Communities, Directive 93/42/EEC, Medical Device Directive (MDD), June 1993. 

The European Union Medical Device Directive (and various other national systems) has adopted a review scheme known as the Essential Requirements Checklist. The manufacturer must meet the essential requirements of the Directive, which is a standardized grouping of attributes for medical products. All devices, regardless of classification or conformity assessment route, must prove that the product meets the essential requirements. Where a harmonized standard exists for the product, and the product meets the standard, it is deemed to automatically meet the essential requirements, but for biotextUes, these are few and far between. One notable device-specific standard for a biotextile vascular graft is ISO 7198 First edition 1998-08-01 Cardiovascular implants - Tubular vascular prostheses, which is recognized by FDA. 

In Europe, medical devices are strictly regulated by the EU s Medical Device Directive (9 3/42/EEC). Other influential bodies are the World Health Organization (WHO), the European Commission, Canada Health, and the International Agency for Research on Cancer (lARC). 

In 2012, a European harmonized version of this standard was adopted by European Committee for Standardization as EN ISO 14971 2012. This version is harmonized with respect to the three European directives associated with MDs Medical Devices Directive 93/42/EEC, In Vitro Diagnostic Medical Device Directive 98/79/EC, and Active Implantable Medical Device Directive 90/385/EEC. This was done to address the presumed compliance with the three directives that is obtained through notified body certification audits and regulatory submissions that claim compliance to this standard. 

Directive 2007/47/EC, which came fully into force on 21 March 2010 and amends the medical devices directives following a review of the existing provisions by the European Commission and member states. In particular the definition of a medical device now includes standalone software used for diagnostic and therapeutic purposes. 

In 1993 the EU issued a directive (European ParUament 2007) which became known as the Medical Devices Directive (MDD). This EU mandate was enacted into UK law in 2002 by the Medical Devices Regulations 2002. These regulations implement the provisions of the Medical Devices Directive, 93/42/EEC. 

European Parliament (2007) Medical devices directives Directive 2007/47/EC of the EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market... 

In medical markets, there are stringent regulatory requirements that must be met before a material can be used for a particular application. It is important to ensure that products that come into close contact with people do not contain any harmful substances that may damage health. Also, more stringent sterilisation methods are generally required for medical devices. Products and materials used for medical applications must be fully characterised, validated and tested for a variety of specifications including USP Class VI, ISO 10993, European Pharmacopoeia and FDA criteria. The EU Medical Devices Directive (93/42/EC) is the most recent framework for specification of medical devices in the European Union. 

Medical Device Directive 98/79/EC (1998) In vitro diagnostic medical devices. http //ec. europa.eu/growth/single-markel/european-standards/harmonised-standards/iv-diagnostic-medi cal-devices/index en.htm... 

In 1996, the European Union (EU) required all manufacturers to have a quality system compliant with ISO 9000 and demonstrate that the products met the requirements of the Medical Device Directive (for safety) in order to gain the right to carry the CE mark. All dental products sold within the EU are required to have the CE mark and to comply with the appropriate ISO standard if one existed. The EU adopted ISO 13485, a quality system for the medical and dental industries superseding ISO 9000 the EDA accepted the use of ISO 13485. 

The pressure equipment directive was adopted by the European Parliament and the European Council in May 1997. It harmonises the national laws of the 15 Member States of the European Union relating to equipment subject to the pressure risk. That directive is one of the series of technical harmonisation directives such as for machinery, medical devices, simple pressure vessels, gas appliances and so on, which were foreseen by the Communities programme for the elimination of technical barriers to trade. It therefore aims to ensure the free placing on the market and putting into service of the equipment concerned within the European Union and the European Economic Area. At the same time it permits a flexible regulatory environment, allowing European industry to develop new techniques increasing thereby its international competitiveness. 

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