Masterarbeit

How to place human medical devices on the market? An overview and critical examination of the regulatory requirements in Germany versus those in the United States ***

Marlene Schulzensohn (2013)

Manufacturers of medical devices need to know and follow specific legal and regulatory requirements if they want to place their devices on the German or United States market. Both, Germany and the USA, have their own distinct regulatory requirements that must be met prior to a manufacturer placing their medical device on the market.

Germany as participant of the European Union is subject to the European Economic Area (EEA) law. On the European Union level the Medical Device Directive (COUNCIL DIRECTIVE 93/42/EEC, known as MDD) of 14 June 1993 is the most essential of three core regulations. The DIRECTIVE 93/42/EEC covers a broad range of medical devices and defines requirements for marketing of medical devices. Important goals of the MDD are harmonization of medical device related laws, elimination of trade barriers and protection of community safety.

Except for certain exclusions, prior to a medical device being first placed on the market within the European Economic Area (EEA) which includes Germany it must bear the CE-Marking and, where required with reference to the conformity assessment, the identification number of the notified body. To receive CE-Marking the device must be assessed during a conformity assessment that depends on the class of the device.

The Federal Food, Drug, and Cosmetic Act (FD&C Act) is federal law and the basic regulation for medical devices. The FD&C Act establishes the power of the Food and Drug Administration (FDA) agency in relation to the supervision over medical devices. The FD&C Act is enforced by the Code of Federal Regulations (CFR). These legally binding rules and regulations, also named administrative law, regulate the most of the medical devices within the 21 CFR Part 800 - 1299.

Unlike in Germany, the USA market does not allow a conformity assessment through a notified body. Instead, a pre-market authorization is required prior to a medical device being first placed on the market in the USA. The pre-market authorization will be issued by the United States Food and Drug Administration (FDA), a regulatory authority in the USA. Basically there are two different types of device authorizations which allow a device to be fully marketed in the USA; the 510(k) premarket notification and Premarket Approval (PMA).

The present master thesis provides a regulatory overview of the current ways on how to place a medical device on the German market and on the US market. The thesis also critically examines regulatory differences between both countries. Beginning with a short introduction of both country legal frameworks, the thesis then gives attention to the specific regulations. Important pre- and post-market requirements and other considerations will be addressed.

Pages: 68, Annexes: A-W, pages: 29