EUROPE The full EU MDR Medical Device definition is: ‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes: diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of …
European Union (deutsch) (english) (espagnol) (français) U.S.A. (FDA) Germany
CE marking is a certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the European Union. The CE marking is the manufacturer’s declaration that the product meets EU standards for health, safety, and environmental protection.
European Committee for Standardization CEN, the European Committee for Standardization, is an association that brings together the National Standardization Bodies of 34 European countries. CEN is one of three European Standardization Organizations (together with CENELEC and ETSI) that have been officially recognized by the European Union and by the European Free Trade Association (EFTA) as …
relating to the maxilla (upper jawbone) and the face. Maxillofacial surgery is a specialization of medicine and/or dentistry that focuses on problems around the mouth, jaw, midface and neck. Anatomical limits and skills differ country-to-country. In some countries doctors attend medical school, dental school and than an additional residency. In other countries they attend either …
AdvaMed, or the Advanced Medical Technology Association, is an American medical device trade association. AdvaMed’s states to promote competitive policies that foster the highest ethical standards, rapid product approvals, appropriate reimbursement, and access to international markets. Some companies follow the “AdvaMed Code of Ethics on Interactions with Health Care Professionals”.
ASTM International (formerly American Society for Testing and Materials), develops and publishes voluntary consensus technical standards for a wide range of materials, products, systems, and services (as of today some 12,575). Headquarter is near Philadelphia, U.S.A. Founded in 1898. ASTM International has no role in requiring or enforcing compliance with its standards. The standards, however, …
Private Label Manufacturer
Original Equipment Manufacturer
Bundesinstitut für Arzneimittel und Medizinprodukte German state authority for pharmaceutical products and medical devices
CleanImplant checks the quality of dental implants by the purity of the implant surfaces.
Agence nationale de sécurité du médicament et de produits de santé France
China Food and Drug Association State Administration for Market Regulation
Central Drugs Standard Control Organisation Directorate General Of Health Services Ministry of Health &Family Welfare, Government of India
European Union Medical Devices Regulation
Unique Device Identification Unique Device Identifier (UDI) established by the FDA The FDA established the unique device identification system to adequately identify medical devices sold in the United States from manufacturing through distribution to patient use. When fully implemented, the label of most devices will include a unique device identifier (UDI) in human- and machine-readable form, which …
Device History Record
In first-party certification, an individual or organization providing the good or service offers assurance that it meets certain claims. In second-party certification, an association to which the individual or organization belongs provides the assurance. Third-party certification involves an independent assessment declaring that specified requirements pertaining to a product, person, process, or management system have been …
A notified body is an independent, third party, accredited body which is entitled by an authorized accrediting body. Upon definition of standards and regulations, the accrediting body may allow a notified body to provide verification and certification services. These services are meant to ensure and assess compliance to the previously defined standards and regulations, but …
ISO develops International Standards, such as ISO 9001, but is not involved in their certification, and does not issue certificates. Certificates are performed by external certification bodies, thus a company or organization cannot be certified by ISO.
International Organization of Standardization ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be …
ISO definition: A device designed to be placed surgically within or on the mandibular or maxillary bone to provide restistance to displacement of a dental prosthesis (ISO 1942:2009). A biocompatible device placed within, or on, bone of the maxilla or mandible, to provide support for a prosthetic reconstruction.
Gesellschaft bürgerlichen Rechts
CE marking is a certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area (EEA). It is the manufacturer’s declaration that the product meets the requirements of the applicable EC directives. The mark consists of the CE logo and, if applicable, the four digit identification …
FDA approved requests are for items that are new or substantially different and need to demonstrate “safety and efficacy”.
FDA clearance requests are for medical devices that prove they are “substantially equivalent” to the predicate devices already on the market.
The Center for Devices and Radiological Health (CDRH) is the branch of the FDA responsible for the premarket approval of all medical devices, as well as overseeing the manufacturing, performance and safety of these devices. The definition of a medical device is given in the FD&C Act. CDRH regulatory powers include the authority to require …
The Food and Drug Administration (FDA or USFDA) is a federal agency of the United States Department of Health and Human Services in the USA. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, …
also: Kassebaum-Kennedy Act An Act To amend the Internal Revenue Code of 1986 to improve portability and continuity of health insurance coverage in the group and individual markets, to combat waste, fraud, and abuse in health insurance and health care delivery, to promote the use of medical savings accounts, to improve access to long-term care …
HIPAA (Health Insurance Portability and Accountability Act Read More »
This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss …
