| 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 |