A.I.S.E. and IHO publish guidelines on Medical Devices


The new Regulation on Medical Devices (2017/745) is expected to come into application on the 26 May 2021 following a postponement of one year due to the COVID pandemic. The new Regulation contains amendments to Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repeals Council Directives 90/385/EEC and 93/42/EEC.

This regulation is of interest to our sector, particularly for PC&H products specifically intended to be used on Medical Devices.

A.I.S.E. has published a guidance document on the Medical Device Regulation. These guidelines were produced by a project team within the IHO’s Medical Devices Working Group, then translated into English and discussed/revised by the experts of the A.I.S.E. Medical Device Task Force. They serve as an industry-specific summary and as an interpretation aid for those new to the topic. They are relevant to companies producing cleaning and/or disinfectant products to be used on medical devices.

The guidance is specifically targeted to industrial and institutional cleaning and disinfectant products.