EU MDR 2017/745
Software for the obligations in Regulation (EU) 2017/745
EU MDR software maps the concrete obligations of Regulation (EU) 2017/745 to daily work. The regulation applies to medical devices placed on the EU market and, through Article 10, requires manufacturers to run a risk management system, a quality management system, clinical evaluation, post-market surveillance and up-to-date technical documentation. MDRpilot organises these obligations per device, ties each one to evidence, and shows which parts are still missing. It supports the work; conformity assessment remains with your notified body.
Who it is for
- Manufacturers of Class I to Class III devices placing products on the EU market
- Persons responsible for regulatory compliance (PRRC, Article 15)
- Teams transitioning MDD certificates under the extended deadlines
Key capabilities
Article 10 overview
Technical file, risk, clinical, PMS and QMS modules mirror the manufacturer obligations, each with its own status.
Annex VIII classification assistant
Answer questions about invasiveness, duration and active function to get a suggested class and rule with a written rationale you confirm.
Annex I GSPR matrix
Every requirement with applicability, justification for non-applicable items, applied standards and linked evidence.
Class-aware PMS outputs
PSUR or PMS report outlines follow the class you set: at least annually for Class IIb and III, at least every two years for Class IIa.
PRRC overview
Readiness score and open actions give the person responsible for regulatory compliance one place to see what is missing.
Where the MDR obligations sit
| MDR provision | What it requires |
|---|---|
| Article 10 | General obligations of manufacturers: risk management, QMS, clinical evaluation, technical documentation, PMS, vigilance |
| Article 15 | A person responsible for regulatory compliance |
| Article 51 and Annex VIII | Classification of devices into Class I, IIa, IIb and III |
| Article 52 and Annexes IX–XI | Conformity assessment procedures |
| Article 61 and Annex XIV | Clinical evaluation and post-market clinical follow-up |
| Articles 83–86 | PMS system, PMS plan, PMS report (Class I) and PSUR (Class IIa, IIb, III) |
| Article 87 | Reporting of serious incidents and field safety corrective actions |
| Annex I | General Safety and Performance Requirements |
| Annexes II and III | Technical documentation and technical documentation on PMS |
Transition deadlines still shape the workload
Regulation (EU) 2023/607 extended the transition for devices with valid MDD or AIMDD certificates: until 31 December 2027 for Class III and Class IIb implantable devices (with some exceptions) and until 31 December 2028 for other Class IIb, Class IIa and Class I devices that need a notified body. The extension is conditional. Among other things, the manufacturer had to have an MDR quality management system in place by 26 May 2024, lodge an application with a notified body by that date and sign a written agreement by 26 September 2024, and the device must not undergo significant changes in design or intended purpose.
For teams in that situation, the practical question is how quickly a legacy file can be brought to MDR depth: Annex I GSPR instead of Essential Requirements, a clinical evaluation that meets Article 61, and PMS documentation under Annex III.
How the workflow runs
- 1
Classify
Document the Annex VIII rule and rationale on the product.
- 2
Map GSPR
Decide applicability and attach evidence for each Annex I requirement.
- 3
Evaluate
Maintain the risk file and clinical evaluation against the same device description.
- 4
Plan post-market
Create the PMS plan, PMCF plan and PSUR schedule for the class.
- 5
Review readiness
Check the open items before the notified body audit.
Connected to the rest of the file
MDRpilot is not a stand-alone document generator. Requirements, evidence and documents share one product record.
Each step reads from the same product record. A test report linked to a GSPR row can verify a risk control, a change to the device class flags the documents that depend on it, and the audit readiness view counts what is still open across all of them.
Limitations
- MDRpilot follows the regulation text and MDCG guidance structures but does not give legal advice on your specific case.
- Deadlines and conditions depend on your certificates and notified body agreements; confirm them with your notified body.
- IVDR (Regulation (EU) 2017/746) devices are not the focus of MDRpilot.
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.
Frequently asked questions
What is EU MDR 2017/745?
Regulation (EU) 2017/745 is the EU law on medical devices. It has applied since 26 May 2021 and replaced the Medical Devices Directive and the Active Implantable Medical Devices Directive.
Does MDRpilot cover IVDR?
No. MDRpilot is built for medical devices under Regulation (EU) 2017/745. In vitro diagnostic devices under Regulation (EU) 2017/746 have different classification rules and performance evaluation requirements.
Does MDRpilot guarantee MDR compliance?
No software can guarantee compliance. MDRpilot makes the requirements, evidence and gaps visible; compliance is demonstrated by your documentation and assessed by your notified body.
Does MDRpilot help with legacy MDD devices?
Yes. You can add a legacy device, record its current state and use the GSPR, clinical and PMS modules to identify what must be added for an MDR file.
Who is the PRRC and can MDRpilot help them?
Article 15 requires manufacturers to have at least one person responsible for regulatory compliance. MDRpilot gives that person a single view of open technical file, QMS and CAPA items; it does not take over their legal responsibilities.
Related workflows
- MDR software that keeps your technical file, evidence and quality records connectedWhat MDR software does, who needs it and how MDRpilot connects technical documentation, GSPR, risk, clinical, PMS and QMS work in one regulatory workspace.Read more
- MDR technical documentation under Annex II and Annex IIIWhat MDR Annex II and Annex III require in the technical documentation, section by section, and how each section is handled in MDRpilot.Read more
- GSPR compliance with evidence you can traceMap every MDR Annex I General Safety and Performance Requirement to applicability, standards and evidence, and see which GSPR rows are still unsupported.Read more
- MDR gap analysis that turns findings into actionsFind what is missing between your current documentation and EU MDR: GSPR evidence, clinical data, PMS, QMS procedures and change-related gaps, with clear next actions.Read more
- PMS and PMCF software that feeds back into risk and clinical evaluationPost-market surveillance under MDR Articles 83–86: PMS plan, PMCF plan and survey, PSUR or PMS report by device class, linked to complaints, CAPA and risk.Read more
Guides and resources
- What Is EU MDR 2017/745?A plain explanation of the EU Medical Device Regulation 2017/745: scope, key dates, classification, conformity assessment, economic operators and what changed from the MDD.Read more
- MDR Annex II and Annex III ExplainedSection-by-section explanation of MDR Annex II (technical documentation) and Annex III (technical documentation on post-market surveillance), with what reviewers look for.Read more
- MDR Gap Analysis GuideHow to run an MDR gap analysis on a technical file and QMS: scope, inputs, a structured review by Annex, prioritisation of findings and turning gaps into a plan.Read more
References
- Regulation (EU) 2017/745 on medical devices (MDR) — EUR-Lex, Publications Office of the European Union.
- Regulation (EU) 2023/607 amending the MDR transitional provisions — EUR-Lex, Publications Office of the European Union.
- Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 and (EU) 2017/746 — EUR-Lex, Publications Office of the European Union.
- MDCG 2021-24 Guidance on classification of medical devices — Medical Device Coordination Group. Listed under classification.
- 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.
See it with your own device
Create an account, add your company and one real device. The Suite demo runs for 3 days and the first procedure opens straight away, not an empty dashboard.