Medical Device (Class I) Compliance Requirements in European Union (EU / EEA)
Applicable Legislation
| Legislation |
|---|
| MDR |
| RoHS Conditional based on product characteristics and decision variables. |
| IVDR Conditional based on product characteristics and decision variables. |
| AI Act Conditional based on product characteristics and decision variables. |
Certification Steps
- 01
Identify applicable legislation
Required: mdr.
- 02
Review conditional legislation
Conditional: rohs, ivdr, ai-act.
- 03
Select harmonised standards
en-60601-12006; en-623042006; en-62366-12015; en-iso-10993-12025; en-iso-111352014; en-iso-11137-12015; en-iso-134852016; en-iso-149712019.
- 04
Assemble required documentation
Gather the documentation required by the applicable legislation (technical file, declarations, test reports).
Applicable Harmonised Standards
Applying these harmonised standards provides a presumption of conformity with the essential requirements of the applicable directives.
| 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.
Data sourced from the EU compliance graph. Verify current requirements before placing products on the market.
Related pages
More compliance requirements and references on Krono Compliance
Directive guide
Directive overview
Aerosols Directive Compliance in European Union (EU / EEA)
aerosolsAI Act Compliance in European Union (EU / EEA)
ai actATEX Compliance in European Union (EU / EEA)
atexBatteries Regulation Compliance in European Union (EU / EEA)
batteriesBlue Guide 2022 Compliance in European Union (EU / EEA)
blue guide 2022Product requirements
Active and intelligent food contact materials Compliance Requirements in European Union (EU / EEA)
active and intelligent food contact materialsActive electrical energy meter Compliance Requirements in European Union (EU / EEA)
active electrical energy meterAdult footwear Compliance Requirements in European Union (EU / EEA)
adult footwearApparatus Compliance Requirements in European Union (EU / EEA)
apparatusArticle (REACH definition) Compliance Requirements in European Union (EU / EEA)
article reach definition