Organizations that put medical devices and in vitro diagnostic products on the market have to adhere to relevant laws, directives and standards.

In the United States, the Food and Drug Administration (FDA) has responsibility to evaluate the suitability of devices for the market and to issue regulations and guidelines for industry. The Center for Devices and Radiological Health (CDRH) is the major program center responsible for this.

Relevant areas that should be considered for products for the US market include device registration and listing, classification, pre-market notification (510k), pre-market approval (PMA) and investigational device exemptions (IDEs).

In Europe, companies need to comply with the Directive 93/42/EEC, which contains a list of Essential Requirements that take account of key areas to address when placing a product on the market. Directive 98/79/EC relates specifically to in vitro diagnostics.

Depending on the classification of the products, the appropriate conformity assessment procedure is applied, and may involve review of the organization’s Quality System and technical documentation by a Notified Body.

We have experience of compiling relevant documentation for compliance in both US and EU markets.