MDR Compliance in European Union (EU / EEA)
Essential Requirements
| Article | Requirement |
|---|---|
| Essential Requirements | Harmonised standards |
Conformity Assessment
Class I (self-declaration except sterile/measuring/reusable sub-classes). Class IIa: Module B+C, D, or F. Class IIb/III: Module B+F or H1. NB required for all but the simplest Class I devices.
Harmonised Standards
Applying these standards creates a presumption of conformity with the applicable essential requirements.
| Standard |
|---|
| EN 60601-1 |
| EN 62304 |
| EN 62366-1 |
| EN ISO 10993-1 |
| EN ISO 11135 |
| EN ISO 11137-1 |
| EN ISO 13485 |
| EN ISO 14971 |
Required Testing & Evidence
Medical QMS evidence
MDR requires a quality management system (ISO 13485).
Typical artifacts: QMS manual, audit reports, procedure records.
Medical device sterilization
Sterilization standards (ISO 11135, ISO 11137) specify requirements for validation and routine control of sterilization processes.
Typical artifacts: Sterilization validation reports, dose mapping, bioburden data, EtO residue reports.
Medical electrical safety and essential performance
Medical electrical equipment standards require verification of basic safety and essential performance.
Typical artifacts: Electrical safety test reports, essential performance verification, usability/risk linkage records.
Medical risk management
MDR requires a risk management system (ISO 14971).
Typical artifacts: Risk management plan, risk management file, benefit-risk analysis.
Co-Applicable Legislation
Products in scope of this legislation may also need to comply with the following:
Data sourced from official EU legislation and the Official Journal. Verify current status before placing products on the market.
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