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The first Harmonised Standards for the Medical Device Regulation (EU 2017/745) and the In-vitro Diagnostic Medical Device Regulation have been published in the Official Journal of the EU.

This is an important development in the medical device sector as Harmonised Standards can be used to demonstrate compliance with the new regulations.

A Harmonised Standard is a European Standard developed by a recognised European Standards Organization (CEN/CENELEC or ETSI).  It is created following a request from the European Commission. 

Manufacturers, economic operators, and conformity assessment bodies can use harmonised standards to demonstrate that products and services or processes comply with relevant EU legislation.

Further implementing decisions regarding other standards will be made by the Commission as more European standard are developed in line with the Commission mandate M/575, which is the request for the development of harmonized standards in support of the MDR and the IVDR.

For the MDR there are 5 standards listed in decision EU 2021/1182, four of these standards address sterilization of healthcare products and one biological evaluation of medical devices.  For more information see this link.

Decision EU 2021/1195 includes four standards listed for the IVDR which all address sterilization of healthcare products.  For more information follow this link.

For more information on medical device standards, contact us.