“The devices must meet the Essential Requirements set out in Annex XYZ [Conformity Assessment Procedures] which apply to them, taking account of the intended purpose of the devices concerned.”
“Member States shall presume compliance with the Essential Requirements….. pursuant to the Harmonized Standards….. published in the Official Journal of the European Communities….”
With some 300 medical device Harmonized Standards published within the Official Journal of the European Communities, the identification of the potentially applicable standards for your product may be challenging. We have generated a working tool to be able to identify the potential scope.
Simply click the appropriate photo below. We are available to you as a local resource to support you in your evaluation process.