- Author
- MDRpilot Editorial Team
- Reviewer
- Independent regulatory review not yet assigned
- Last updated
- Applies to
- EU MDR 2017/745 Annex I
How Annex I is organised
| Chapter | Requirements |
|---|---|
| Chapter I, Sections 1–9 | Devices must achieve their intended performance and be safe; risk management; reducing risks as far as possible; benefit-risk; lifetime; transport and storage; side effects |
| Chapter II, Sections 10–22 | Chemical, physical and biological properties; infection and microbial contamination; devices with a medicinal substance; materials of biological origin; interaction with the environment; diagnostic and measuring functions; radiation; electronic programmable systems and software; active devices; mechanical and thermal risks; energy or substance delivery; devices for lay persons |
| Chapter III, Section 23 | Label, sterile packaging and instructions for use |
What a GSPR checklist row contains
- The requirement number and short text
- Applicable: yes or no
- Justification when not applicable, consistent with the device description
- Method of demonstrating conformity: standard, test, analysis, clinical data
- Standards and common specifications applied, with edition
- Reference to the controlled document or report that provides evidence
Harmonised standards and other solutions
Under Article 8, devices that conform to harmonised standards published in the Official Journal are presumed to conform to the requirements covered by those standards. Using them is voluntary. If you use another standard, an older edition or an in-house method, the checklist should explain why that solution achieves an equivalent level of safety and performance. The Annex Z tables in EN standards show which GSPRs a harmonised standard covers.
Mistakes reviewers find most often
- Requirements marked not applicable without a reason, for example Section 10.4 on substances for devices that contact the body
- A standard listed but the test report follows a different edition
- Evidence referenced as a folder rather than a specific document
- Software requirements in Section 17 ignored for devices with embedded firmware
- Section 23 labelling requirements not cross-checked against the actual IFU
How MDRpilot supports GSPR work
The GSPR module holds every Annex I requirement per product with applicability, justification, applied standards and linked evidence. Uploaded test reports are read for their standard and verdict and proposed as evidence for matching rows; a user confirms each link. Reports with a fail verdict are not linked and add a gap note. The checklist exports as XLSX.
References
- Regulation (EU) 2017/745 on medical devices (MDR) — EUR-Lex, Publications Office of the European Union.
- Guidance: MDCG endorsed documents and other guidance — European Commission.
Always check the consolidated text of the regulation and the current version of each guidance document before relying on it.
This guide is general information about the regulation and standards named above. It is not legal or regulatory advice for a specific device.
MDRpilot is documentation and workflow software. It is not a medical device, not a notified body and not a regulatory authority. It does not certify devices or guarantee compliance; AI-generated drafts must be reviewed and approved by qualified people in the manufacturer's organisation.