Montag, 17 Jun 2024
Normen & Normung: Regularien in der Pharmazie und Medizintechnik


 European In Vitro Diagnostic Device Directive (IVDD) – 98/79/EC

"Direct link to the European directive 98/79/EC on in vitro diagnostic medical devices."


Revision of the Medical Devices Directives

"The Commission is considering a revision of the legal framework for Medical Devices in order to improve and strengthen this framework and to meet the growing expectations of European citizens since the last technical revision brought about by Directive 2007/47/EC.

Experience indicates that the current system does not always offer a uniform level of protection of public health in the European Union. New and emerging technologies have challenged the current framework, highlighting gaps and pointing to a certain scarcity of expertise. In addition, in recognition that the medical devices market is a global one, to keep European industry competitive, the Community regime needs to further converge on the 'global model'. And finally, the legal system has been criticised as being too fragmented and difficult to follow and fraught with national variation."

Related topics: "The New Approach and European standardisation have contributed significantly to the development of the Single Market. The success of the European standardisation system, in removing technical barriers to trade, has played a vital role in ensuring the free movement of goods between Member States."

International Medical Device Regulators Forum

"The International Medical Device Regulators Forum (IMDRF) was conceived in February 2011 as a forum to discuss future directions in medical device regulatory harmonization.

It is a voluntary group of medical device regulators from around the world who have come together to build on the strong foundational work of the Global Harmonization Task Force on Medical Devices (GHTF), and to accelerate international medical device regulatory harmonization and convergence."

FDA - United States Food and Drug Administration

"The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation, and by regulating the manufacture, marketing, and distribution of tobacco products.

The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods, and to reduce tobacco use to improve health."


FDA - Medical Device Regulations and Guidance

FDA - Quality Systems Regulation


ISO - International Standards Organisation

"ISO (International Organization for Standardization) is the world's largest developer and publisher of International Standards.

ISO is a network of the national standards institutes of 163 countries, one member per country, with a Central Secretariat in Geneva, Switzerland, that coordinates the system.

ISO is a non-governmental organization that forms a bridge between the public and private sectors. On the one hand, many of its member institutes are part of the governmental structure of their countries, or are mandated by their government. On the other hand, other members have their roots uniquely in the private sector, having been set up by national partnerships of industry associations.

Therefore, ISO enables a consensus to be reached on solutions that meet both the requirements of business and the broader needs of society."


ANSI - American National Standards Institute

"As the voice of the U.S. standards and conformity assessment system, the American National Standards Institute (ANSI) empowers its members and constituents to strengthen the U.S. marketplace position in the global economy while helping to assure the safety and health of consumers and the protection of the environment.

The Institute oversees the creation, promulgation and use of thousands of norms and guidelines that directly impact businesses in nearly every sector: from acoustical devices to construction equipment, from dairy and livestock production to energy distribution, and many more. ANSI is also actively engaged in accrediting programs that assess conformance to standards – including globally-recognized cross-sector programs such as the ISO 9000 (quality) and ISO 14000 (environmental) management systems."

Deutsches Institut für Normung e.V.

"Das DIN Deutsches Institut für Normung e.V. bietet allen Interessierten die Plattform zur Erarbeitung von Normen und Standards als Dienstleistung für Wirtschaft, Staat und Gesellschaft. Das DIN ist privatwirtschaftlich organisiert mit dem rechtlichen Status eines gemeinnützigen Vereins. Der Geschäftssitz ist seit 1917 in Berlin. Die Hauptaufgabe des DIN besteht darin, gemeinsam mit den Vertretern der interessierten Kreise konsensbasierte Normen markt- und zeitgerecht zu erarbeiten. Hierfür bringen rund 28.000 Expertinnen und Experten ihr Fachwissen in die Normungsarbeit ein.  Auf Grund eines Vertrages mit der Bundesrepublik Deutschland ist das DIN als die nationale Normungsorganisation in den europäischen und internationalen Normungsorganisationen anerkannt. Heute ist die Normungsarbeit des DIN zu fast 90 Prozent europäisch und international ausgerichtet."

ASTM - American Society for Testing and Materials

BSI - British Standards Institute

CEN - European Committee for Standarization

CSA - Canadian Standarisation Organisation

GMP Institute - The Global Leader for GMP Training

NNI - Netherlands Normalisatie instituut