How to tell them apart
Common Specifications are technical or clinical requirements adopted by the European Commission. Under the MDR they fill gaps where harmonised standards are missing; under the IVDR they carry extra weight, especially for Class D IVDs. The context (device vs. IVD) tells you which regulation applies.
- Meaning 1 · RegulatoryCommon SpecificationsMandatory technical specifications under EU MDR/IVDR where harmonized standards are insufficient.Read the full definition
- Meaning 2 · RegulatoryCommon Specifications (IVDR)Technical or clinical requirements adopted by Commission implementing act that manufacturers must comply with unless a demonstrably equivalent alternative is used.Read the full definition