Medical Device Directive definition
Examples of Medical Device Directive in a sentence
Safety and effectiveness requirements closely correspond to the essential requirements of the Medical Device Directive.
Manufacturer agrees that all design change, approval, and revision control shall be consistent with Good Manufacturing Practices and the Medical Device Directive, as published by the European Parliament.
Diametrics shall retain records of any safety, quality and reliability related data relating to the Portal Measurement Products as well as any data necessary for "Current Good Manufacturing Practices" (CGMP, as required by FDA), the "In Vitro Diagnostics Directive" (the IVDD, as required by the European Union) and the "Medical Device Directive" (MDD, as required by the European Union), to the extent provided under Schedule 1, Required Quality Data.
The BISx and BISx4 comply with the essential requirements of the Medical Device Directive 93/42/EEC, as well as IEC 60601-1 and IEC ▇▇▇▇▇-▇-▇▇.
Seller is compliant with, but not registered or certified to: (i) Pharmaceutical Affairs Law 2002 (PAL) [Japan]; (ii) Medical Device Directive 93/42/EEC [Europe]; (iii) ISO 60601-1, and (iv) ISO ▇▇▇▇▇-▇-▇.