Laboratory Medicine & IVD

Laboratory medicine and in-vitro diagnostics form a world of their own within the register, with their own regulatory framework: since the IVDR, considerably stricter requirements have applied to reagents, analysers, sample tubes and software — one reason why the supply chain here depends particularly heavily on specialist partners. The category brings together manufacturers of analytical systems and consumables, reagent producers, OEM suppliers of single-use plastic articles and testing and calibration laboratories.

On the supply side, plastic injection moulding under cleanroom conditions dominates: pipette tips, cuvettes, microtitre plates and primary vessels require Class 7 or 8 to ISO 14644-1, often with certified DNase/RNase-free status. In-house toolmaking and experience with multi-cavity moulds are the decisive selection criteria here, together with ISO 13485 with an explicit IVD scope.

With instruments, in turn, what counts is electronics manufacturing, fluidics expertise and a software life cycle to IEC 62304. The register's search allows these axes to be combined — for example cleanroom injection moulding plus ISO 15378 for primary packaging materials, or electronics manufacturing plus IVD experience.