Whitepaper On Decisions Commission Implementing (EU)

New Harmonized standard list for the Medical Devices Directives (EU MDD) was published in the Official Journal of European Union on 24 March 2020. The current lists of harmonized standards related to the directive MDD 93/42/EEC. The purpose of this website is to provide access to the latest lists of references of harmonized standards and other European standards published in the Official Journal of the European Union (OJEU).

A harmonized standard is a European standard developed by a recognized European Standards Organization: CEN, CENELEC, or ETSI. It is created following a request from the European Commission to one of these organizations. Manufacturers, other economic operators, or conformity assessment bodies can use harmonized standards to demonstrate that products, services, or processes comply with relevant EU legislation.

Latest Harmonized standard list for the Medical Devices in support of Directive 93/42/EEC:

The references of the harmonized standards for medical devices drafted in support of Directive 93/42/EEC are published in the Official Journal of the European Union. This Decision enter into force on the day of its publication in the Official Journal of the European Union i.e. 24 March 2020 and shall apply until 26 May 2024.

The total list of Harmonized Standards published is 264 and are listed in Annex I of the Decision.

The requirements for medical devices laid down in the Directive 93/42/EEC are different from those laid down in Regulation (EU) 2017/745. The standards drafted in this should not be used to demonstrate conformity with requirements of Regulation (EU) 2017/745.

The changes in the lists of harmonized standards are summarized in the table below.