> regulation_(eu)_2017/745
Regulation (EU) 2017/745
European Medical Device Regulation (EU MDR)
Regulation (EU) 2017/745 (EU MDR) governs the clinical investigation, placing on the market, and putting into service of medical devices in the European Union. Under Rule 11, it significantly elevated the classification of Software as a Medical Device (SaMD), subjecting most clinical software to notified body audit, stringent clinical evaluation, unique device identification (UDI), and continuous post-market surveillance.
Scope & Applicability
Mandatory for all medical devices and software placed on the EU market, whether manufactured inside or outside the European Union.
Non-Coverage Boundaries
Does not apply to in vitro diagnostic medical devices (which are governed by EU IVDR 2017/746) or generic lifestyle/wellbeing consumer software.
Key Clauses & Control Requirements
Rule 11 (Software Classification)
Software intended to provide information used to take decisions with diagnosis or therapeutic purposes is classified as Class IIa or higher.
Electronic Programmable Systems & Cybersecurity
Requires devices that incorporate software to be designed taking into account the principles of development life cycle, risk management, and cybersecurity.
Required Regulatory & Audit Evidence Artifacts
- [✓]Technical Documentation File (Annex II and III)
- [✓]Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER)
- [✓]Notified Body CE Certificate of Conformity
“Under MDR Rule 11, almost no diagnostic software remains low-risk Class I. If your SaaS influences clinical decisions, you need notified body scrutiny and clinical evidence.”
Cross-Surface Ecosystem Relationships
- Regulation (EU) 2017/745 on medical devices ↗(European Union)
Frequently Asked Questions
What is the significance of Rule 11 in EU MDR?
Rule 11 dramatically up-classified clinical software from Class I (self-certification) to Class IIa, IIb, or III, requiring mandatory independent notified body audits.