Links below give access to the key documents describing the EU and the USA regulations. For questions on application and interpretation of these documents please contact QAid at post@QAid.nl

The text of the Medical Device Directive: MDD-text and of the In Vitro Diagnostic Medical Devices Directive: IVD-text

Standards to show compliance with the Essential Requirements of the Medical Device Directive: MDD-standards and with the Essential Requirements of the In Vitro Diagnostic Medical Devices Directive: IVD-standards. Get your standards for example through NEN.

Notified Bodies play a major role in the assessment of the conformity of your device and quality system with guidelines and directives. The Notified Bodies for Medical Devices: Notified Bodies (MDD) and for In Vitro Diagnostic Medical Devices: Notified Bodies (IVD)

Registration of manufacturers and devices are needed at the Competent Authorities.

European guidelines supporting interpretation and implementation of the Medical Device Directive and In Vitro Diagnostics Directive: MEDDEV

CDRH is that part of the FDA dealing with medical devices. The FDA recognizes many international standards to show compliance with regulatory requirements: FDA Recognized Standards.

Are similar devices on the USA market? Then you probably can use the 510(k)-route. CDRH gives lots of information on how this route works.