Biomaterial Database

The European legislation on medical devices. 1996

N Anselmann

European Commission, DGIII D.2, Brussels, Belgium.

The protection of health and safety of patients and users, is the main objective of the comprehensive, harmonised legislation created in the EU, in the area of medical devices. In this paper, a brief description of the legislative programme is presented,-giving details on the three medical device directives, as well as their transposition. A detailed analysis of the directives context follows, with the steps and actions that all involved parties have followed or need to follow to ensure their uniform application.

UI	MeSH Term	Description	Entries
D007883	Legislation, Medical	Laws and regulations, pertaining to the field of medicine, proposed for enactment or enacted by a legislative body.	Medical Legislation
D004864	Equipment and Supplies	Expendable and nonexpendable equipment, supplies, apparatus, and instruments that are used in diagnostic, surgical, therapeutic, scientific, and experimental procedures.	Apparatus and Instruments,Devices,Medical Devices,Device, Medical,Devices, Medical,Equipment,Inventories,Medical Device,Supplies,Device,Instruments and Apparatus,Inventory,Supplies and Equipment
D004869	Equipment Safety	Freedom of equipment from actual or potential hazards.	Device Safety,Hazards, Equipment,Medical Device Safety,Safety, Equipment,Device Safety, Medical,Safety, Medical Device,Equipment Hazard,Equipment Hazards,Hazard, Equipment,Safety, Device
D005062	European Union	An economic union with the principal objectives of free movement of goods, capital, and labor. The constituent countries are Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, and Sweden. (https://europa.eu/european-union/about-eu/countries accessed 12/31/2020)	Common Market,Euratom,European Atomic Energy Community,European Coal and Steel Community,European Common Market,European Community,European Economic Community,Community, European Economic,EEC,Economic Community, European,Common Market, European,Common Markets,Common Markets, European,Communities, European,Communities, European Economic,Community, European,Economic Communities, European,European Common Markets,European Communities,European Economic Communities,Market, Common,Market, European Common,Union, European