CFR 4 Medical Device – Combination Product SOP


This CFR 4 Standard Operating Procedure (SOP) describes the requirements according to 21 CFR Part 4 for combination products. For the European market, when a device is placed on the market forming a single integral product together with a medicinal product and it is not reusable, it shall be governed by the Medicinal Products Directive 2001/83/EC (MPD) applying the requirements of Annex I to the Medical Devices Directive 93/42/EEC (MDD), as far as safety and performance-related device features are concerned.