MEDICAL DEVICES AND IN VITRO DIAGNOSTICS GUIDELINES

NumberFile NameYearVersionDocument TypeDownload
5.08Revised Guideline -DONATION OF MEDICINES MEDICAL DEVICES AND IVDs20213Guideline
8.02Medical Device IVD Essential Principles20192Guideline
8.04Recalls Vigilance Medical Devices IVDs20193Guideline
8.05CLASSIFICATION of MEDICAL DEVICES and IVDs20215Guideline
8.07Medical Device Quality Manual20193Guideline
16.03Licence Medical Devices IVDs20202Guideline
MD004Extension – Use of acknowledgement letter in lieu of a licence20201Guideline
MD010Guidance Rapidly developed ventilator20201Guideline