Medical devices

The EU Medical Devices Regulation came into force on the 26 May 2017. The goal of the Regulation is to create a harmonised European medical devices legislation, which will ensure the availability of safe medical devices and fast market access, combined with balanced monitoring before and after the product launch.

The new EU 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 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 the detergents sector, as it covers professional cleaning and hygiene products specifically intended to be used on medical devices.

A.I.S.E. has published guidelines on the Medical Device Regulation. This guidance is a collaboration between IHO’s Medical Devices Working Group and the A.I.S.E. Medical Device Task Force. The guidelines serve as an industry-specific summary and as an interpretation aid for those new to the topic, and is of particular relevance for companies producing cleaning and/or disinfectant products to be used on medical devices. 

The guidelines are specifically targeted to industrial and institutional cleaning and disinfectant products, and is therefore part of A.I.S.E.'s toolkit of material for the professional cleaning sector.