The term IVD covers a diverse range of products from individual reagents to specimen receptacles to entire medical testing systems. IVDs are defined as medical devices which can be a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system, intended for in-vitro examination of specimens, derived from the human body.[i] 

Because IVDs are considered medical devices, they are regulated by the health authority in each country and import compliance enforced by the Customs service. Empty diagnostic kits shipped globally to support clinical trials often contain IVDs so importers of empty kits containing IVDs must comply with local regulations for import, distribution and use of IVDs.

IVD regulations, especially as they pertain to importation, will vary from country to country. However, in general, imported IVDs must:

  • Be declared to Custom and other relevant control agency for import approval
  • Have CE mark for Europe, or equivalent conformity identifying mark, e.g. CCC in China, UL in the USA etc. (unless exempt)
  • Be registered (unless exempt)

Investigational IVDs are typically exempt from CE mark and registration requirements. Investigational IVDs are those products which are the subject of clinical research and imported under an approved protocol. Investigational IVDs may also include products imported for standards conformity testing or performance evaluation. However, IVDs imported as ancillary clinical supplies are not considered investigational and must comply with CE mark and registration requirements.

If an importer is unsure about a product included in a kit, they should contact the product’s manufacturer. IVD manufacturers may be able to provide information about a product’s IVD classification, CE mark and country specific registration status.

 


Daniel J Bell, Vice President, Regulatory Compliance & Technical Affairs  

 

[i] Council Directive 93/42/EEC