5737 PM Lieshout
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
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.
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.