Directive 93/42 definition
Examples of Directive 93/42 in a sentence
With respect to the R2 Product, R2, at its expense, will be responsible for obtaining and maintaining, in R2’s name: (a) FDA and other applicable United States regulatory agency approvals; (b) ISO9000 certification; (c) CE certification in accordance with the provisions of Directive 93/42 governing medical devices for the R2 Product; and (d) applicable regulatory approvals in Canada.
In accordance with the requirements of Medical Device Directive 93/42 EWG, ISO 13485, and ISO 9001 standards, Distributor will permanently maintain a complete record of all Products sold and installed in the Territory (the "Tracking Report").
Licensee, CIBA and their respective affiliates hereby agree to work cooperatively to complete all requirements to commence the marketing and sale of the Products in the European Union in accordance with Medical Device Directive 93/42 EEC (the "MDD").
CODMAN will be responsible to carry all activities of the authorized representative as defined in the EU Medical Device Directive 93/42.
In accordance with the applicable requirements of Medical Device Directive 93/42 EWG, ISO 13485, and AATB and "361" HCT/Ps Standards, Distributor will permanently maintain a complete record of all Products sold and installed in the Territory ("Tracking Report").