- Author
- MDRpilot Editorial Team
- Reviewer
- Independent regulatory review not yet assigned
- Last updated
- Applies to
- EU MDR 2017/745 Article 15
What makes SMEs different
- One person often owns the QMS, the technical file and complaints
- Device portfolios are small but each file must meet the same MDR depth
- External consultants and test labs provide much of the expertise
- Notified body fees are a significant cost, so avoidable review rounds matter
- Budgets favour monthly plans over multi-year enterprise contracts
Requirements that matter most
| Need | Why |
|---|---|
| Reuse of device data | No time to retype the device description in every document |
| Explicit gaps | A short list of what is missing is more useful than a long report |
| Drafting support | Procedures and sections from confirmed facts reduce blank-page work |
| Consultant role | External experts work in the same file with limited permissions |
| Exports | Files go to the notified body in standard formats |
| Proportionate price | Paying per product and seat matches a small portfolio |
The PRRC question
Article 15 requires at least one person responsible for regulatory compliance with documented expertise. Article 15(2) allows micro and small enterprises, as defined in Commission Recommendation 2003/361/EC, to have such a person permanently and continuously at their disposal instead of within their organisation. Software can give the PRRC a clear overview of open items, but it does not take over the role.
How MDRpilot fits SMEs
MDRpilot plans are priced per month by number of products and seats, from one product and one seat upward, with an enterprise option for custom limits. A free Starter account gives access to Document Studio, and a 3-day Suite demo can be requested at sign-up. Consultants can be invited into a company workspace with a consultant role. Pricing details are on the home page.
References
- Regulation (EU) 2017/745 on medical devices (MDR) — EUR-Lex, Publications Office of the European Union.
- Medical devices: new regulations — European Commission, Directorate-General for Health and Food Safety.
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.