11/02/2015

Obelis SA Obelis European Authorized Representative Center

NEW list of harmonized standards for medical devices

The European Commission has published the new list of European standards relating to medical devices.


On 16th of January 2015 The European Commission published a number of Communications providing an updated list of harmonized standards in the framework of the following Council Directives:
•Medical Devices Directive 93/42/EEC
•In-vitro Diagnostic Medical Devices 98/79/EC
•Active Implantable Medical Devices 90/385/EEC


The harmonized standards specify the basic requirements that Medical Devices must fulfill under the EU directives, as such staying up-to-date about the latest changes is vital for manufacturers willing to affix the CE Mark and i their device into the EU market.


New lists of harmonized standards:


Medical Devices: The list contains 1 new standard:
•EN ISO 8359:2009/A1:2012


In-vitro Diagnostic Medical Devices: The list contains 2 new standards:
•EN ISO 11137-2:2013 Sterilization of health care products – Radiation: Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
•EN ISO 13408-1:2011/A1:2013


Active Implantable Medical Devices: The list contains 3 new standards:
•EN ISO 11137-1:2006/A1:2013
•EN ISO 11137-2:2013 Sterilization of health care products – Radiation: Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
•EN ISO 13408-1:2011/A1:2013


The full list of the applicable harmonized standards can be found on the European Commission website. Any information concerning the availability of the standards can be obtained either from the European standardization organizations or from the national standardization bodies.


If you want to know more about the applicable standards for your product, please contact us.