GUIDE AIMD MDD - Cyprus Organization for the Promotion of Quality

Guide on MDD + AIMD DirectiveEuropeAid /114385/D/SV/CYThe most suitable standard(s) should be selected in cooperation between the manufacturer and thenotified body, if any, in such a way as to minimise the risk that products might not comply with theEssential Requirements.The European standards organisations i.e. the European Committee for Standardisation (CEN) and theEuropean Committee for Electrotechnical Standardisation (CENELEC) develop European standards tocover various products or product groups.Once a European standard has been agreed, it becomes binding on all national standards bodies inEurope, and any conflicting national standard has to be withdrawn.European standards, mandated by the European Commission, that are accepted as addressing identifiedEssential Requirements in a Directive are listed in the Official Journal of the European Communities, andare generally referred to as harmonised standards. Products manufactured in line with such standards willbe presumed to comply with the relevant Essential Requirements unless there is specific evidence to thecontrary.Many standards are developed at a wider international level, through the International Organisation forStandardisation (ISO) and the International Electrotechnical Commission (IEC). Very often the finallypublished ISO or IEC standard is also adopted as a European standard.Other harmonised standards will define the characteristics of manufacturers' quality management systemswhich are relied on to ensure that medical devices are designed and manufactured correctly. Again thereis a presumption of compliance if a quality management system complies with the relevant harmonisedstandard i.e. the notified body must presume that it complies with the requirements of the Directive.Manufacturers may choose whether or not to apply relevant harmonised standards. In practice, however,compliance with these standards will be the easiest way of showing that their products meet the EssentialRequirements.Since the application of harmonised standards will be voluntary, manufacturers may choose alternativemethods of demonstrating compliance with the Essential Requirements.For example, manufacturers may use international, national or in-house standards. These alternativeroutes may also be used where harmonised standards do not exist for a particular product or EssentialRequirement(s).Further information on standards and guidance information can be obtained from the Standards Body ofCyprus:CYSCyprus Organisation for the Promotion of QualityAt the Ministry of Commerce, Industry and Tourism13-15, Andreas Araouzou Street1421 NicosiaInternet : http://www.cys.mcit.gov.cyCENEuropean Committee for StandardizationRue de Stassart, 36, B - 1050 BRUSSELSTel: +32.2.550 08 11Fax: +32.2.550 08 19Internet : http://www.cenorm.be