Each of the three medical device directives has an ‘Annex I’ that defines the ‘Essential Requirements’ (ERs) that must be met before the CE mark can be applied and the product legally marketed in the EEA.
Identification of the ERs relevant to individual devices is an important part of the compliance process, as each device Technical File requires a description of how the manufacturer meets the identified ERs. In addition, under the revised Medical Device Directive (MDR) that took effect from March 2010, for devices that also fall under the Personal Protective Equipment (PPE) and Machinery Directives, the ERs will need to be augmented by incorporating relevant requirements from these directives.
The most straightforward method of demonstrating compliance with individual ERs is to verify compliance with the relevant clauses of European Harmonised Standards, which give a so-called ‘presumption of conformity’ to the ERs.
GEMAR can help you complete this important foundation stone in building your Technical File, by assisting with identification of the relevant ERs and the associated Harmonised Standards - contact us for further information.