Compliance Requirements for In Vitro Diagnostic Device in European Union (EU / EEA)
Applicable Legislation
| Legislation |
|---|
| MDR |
| IVDR |
| RoHS Conditional based on product characteristics and decision variables. |
| AI Act Conditional based on product characteristics and decision variables. |
Harmonised Standards
| Reference | Status |
|---|---|
EN 60601-1:2006 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance | active |
EN 62304:2006 Medical device software - Software life cycle processes | active |
EN 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices | active |
EN ISO 10993-1:2025 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process | active |
EN ISO 11135:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices | active |
EN ISO 11137-1:2015 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices | active |
EN ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes | active |
EN ISO 14971:2019 Medical devices - Application of risk management to medical devices | active |
Required Documents
| Document |
|---|
Carbon Footprint Declaration Carbon Footprint Declaration template and guidance based on official CE requirements. |
Declaration of Incorporation Declaration of Incorporation template and guidance based on official CE requirements. |
Declaration of Performance Declaration of Performance template and guidance based on official CE requirements. |
EU Declaration of Conformity EU Declaration of Conformity template and guidance based on official CE requirements. |
Technical Documentation Technical Documentation template and guidance based on official CE requirements. |
Certification Steps
- 01
Identify applicable legislation
Required: mdr, ivdr.
- 02
Review conditional legislation
Conditional: rohs, 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).
Data sourced from the EU compliance graph. Verify current requirements before placing products on the market.