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.