IVDMDD Horizontal Standards
EN ISO 18113-4
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing
EN ISO 18113-5
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing
EN ISO 13408-1
Aseptic processing of health care products - Part 1: General requirements
EN ISO 13408-2
Aseptic processing of health care products - Part 2: Filtration
EN ISO 13408-3
Aseptic processing of health care products - Part 3: Lyophilization
EN ISO 13408-6
Aseptic processing of health care products - Part 6: Isolator systems
EN ISO 13485
Medical devices - Quality management systems - Requirements for regulatory purposes
EN 14136
Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures
EN 13641
Elimination or reduction of risk of infection related to in vitro diagnostic reagents
EN ISO 14971
Medical devices - Application of risk management to medical devices