medical devices directives Europe and USA
EUROPE
European Commission has developed specific guidelines for the interpretation and implementation of the medical devices Directives, following a common approach, addressed to the stakeholder (Competent Authorities, Notified Bodies and manufacturers). The guidelines documents are published on the European Commission website.
The European regulation on medical devices is covered by three Directives, depending on the type of devices.
The following documents are the consolidated versions of the current Directives as amended:
Consolidated version Active Implantable Medical Devices Directive - Council Directive 90/385/EEC of 20 June 1990
Consolidated version Medical Devices Directive - Council Directive 93/42/EEC of 14 June 1993
Consolidated version In Vitro Diagnostic Medical Devices Directive - Directive 98/79/EEC of 27 October 1998
European Commission has developed specific guidelines for the interpretation and implementation of the medical devices Directives, following an common approach, addressed to the stakeholder (Competent Authorities, Notified Bodies and manufacturers).
The European Commission has also published “Interpretative Documents” in relation to specific aspects of the Directives.
The "Guidelines" and “Interpretative" documents can be downloaded at the following page of the European Commission Website.
European Commission GuidelinesBased on the New Approach, rules relating to the safety and performance of medical devices were harmonised in the EU in the 1990s. The core legal framework consists of 3 directives:
- Directive 90/385/EEC regarding active implantable medical devices,
- Directive 93/42/EEC regarding medical devices and
- Directive 98/79/EC regarding in vitro diagnostic medical devices.
They aim at ensuring a high level of protection of human health and safety and the good functioning of the Single Market. These 3 main directives have been supplemented over time by several modifying and implementing directives, including the last technical revision brought about by Directive 2007/47/EC.
European Regulatory framework
United States
The provisions on medical devices regulations for United States are defined in the Title 21 of the US Code of Federal Regulations (CFR).
The part of the Federal Code related to medical devices is contained in the Title 21 of the CFR Part 800-1299. In order to market the product in the United States it’s necessary to obtain a specific authorisation by the US agency Food and Drug Administration (FDA). FDA website presents a complete overview of the regulations and guidances on medical devices for United States.
Herewith you can find the relevant links of FDA regulations for medical devices:
FDA Website
GLOBAL HARMONISATION TASK FORCE (GHTF)
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.