Number | File Name | Year | Version | Document Type | Download |
---|---|---|---|---|---|
8.02 | Medical Device IVD Essential Principles | 2019 | 2 | Guideline | Download PDF |
8.04 | Recalls Vigilance Medical Devices IVDs | 2019 | 3 | Guideline | Download PDF |
8.05 | Classification Medical Devices IVDs | 2019 | 2 | Guideline | Download PDF |
8.07 | Medical Device Quality Manual | 2019 | 3 | Guideline | Download PDF |
16.03 | Licence Medical Devices IVDs | 2020 | 2 | Guideline | Download PDF |
MD004 | Extension – Use of acknowledgement letter in lieu of a licence | 2020 | 1 | Guideline | Download PDF |
MD010 | Guidance Rapidly developed ventilator | 2020 | 1 | Guideline | Download PDF |