MDCG guidance on standardisation for medical devices

The MDCG document pursues to provide guidance on several features related to standards in the medical devices industry supporting the requirements set down in the applicable European legislation considering its specificities.

The contents of this guidance include:

  1. EU legislation on medical devices, consisting of three current Directives and two new Regulations. In this type of legislation, the role of harmonised European standards is essential since it establishes essential requirements that . . .

    Oh! It looks like you do not have access to this page.
    Find the membership plan that suits you, and within a few minutes you are good to go.
    Are you a member already? Log in here.