Navigating the regulatory submission process for a class III medical device with ancillary medicine
Medical devices come in all shapes, sizes and varieties, from something as simple as a plaster to something as life-essential as cardiac pacemakers. No matter the type of device they all must meet the requirements of the Medical Device Directive 93/42/EEC (MDD), and soon the Medical Device Regulation EU 2017/745 (MDR), in order to be CE-marked and placed on the market in Europe. However, if the device incorporates a medicinal product, additional requirements are also to be met.
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