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Links & Downloads

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 Devices Regulation: MDR-text and of the In Vitro Diagnostic Regulation: IVDR-text

Standards to show compliance with the General Safety and Performance Requirements of the Medical Devices Regulation: MDR-standards and with the General Safety and Performance Requirements of the In Vitro Diagnostic Medical Devices Regulation: IVDR-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 regulations and guidelines. The Notified Bodies for Medical Devices: Notified Bodies (MDR) and for In Vitro Diagnostic Medical Devices: Notified Bodies (IVDR)

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

European guidelines supporting interpretation and implementation of the Medical Devices Regulation and In Vitro Diagnostics Regulation: MEDDEV and MDCG endorsed documents

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.

Quality matters