MEDICAL DEVICES AND IN VITRO DIAGNOSTICS GUIDELINES

NumberFile NameYearVersionDocument TypeDownload
8.02Medical Device IVD Essential Principles20192Guideline
8.04Recalls Vigilance Medical Devices IVDs20193Guideline
8.05Classification Medical Devices IVDs20192Guideline
8.07Medical Device Quality Manual20193Guideline
16.03Licence Medical Devices IVDs20202Guideline
MD004Extension – Use of acknowledgement letter in lieu of a licence20201Guideline
MD010Guidance Rapidly developed ventilator20201Guideline