Common Specifications (CS) on the reprocessing and further re-use of single-use medical devices within a health institution, as foreseen in Articles 17(3) and 17(5) of the Medical Devices Regulation (MDR), have now been published in the EU Official Journal.

These CS have been published in the form of the following MDR Implementing Act: Commission Implementing Regulation 2020/1207 of 19 August 2020, which enters into force on 9 September and shall apply from the MDR date of application: 26 May 2021.

For more information and to view the Journal, go to the Documents Library.

Membership is open to Manufacturers of Sterilisation products or related services, with sales in Europe. Potential members also need to have implemented a quality management system certified by an accredited certification body.

For more details see Why become a member?

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