New Guidance Notes

19th Sep 2017

These Guidance notes are useful and give good insight into how to use the regulations. If you have them as part of your quality system, please do not forget to update the quality documents.

There are also Guidance notes on the other relevant Directives such as the LVD and the EMC.

REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

For those companies involved in the supply and servicing of medical weighing equipment it should be noted that these Regulations have replaced the Medical Devices Regulations 93/42.

The original Directive is repealed from 26th May 2020. It appears that the substantive changes are to bring the requirements in to line with the requirements of the new legislative framework.

It must be remembered that if the manufacturer of any medical equipment is outside the EU, they must have an authorized representative in the EU. It is unclear how the process of leaving the EU will treat this but we should think about this now.

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