European Union Medical Device Directive

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 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. 

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. 

International regulations play a significant role in the marketing and use of medical devices. The European Union Council Directive concerning medical devices is the international equivalent of... 

Biocompatibility involves adherence to ISO 10993 Biological Evaluation of Medical Devices or USP Class VI standards, hemocompatibility, platelet retention, and reduced protein binding. Moreover, food contact standards are typically applied to healthcare applications. The US Food and Drug Administration oversees adherence to the standards of the US Food, Drug, and Cosmetics Act In Europe, the European Union Directive 2002/72/EC is applicable. 

In the European Union the legal core framework of medical devices consists of three main directives, which define the safety and performance requirements ... 

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