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Dec 04
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PharSafer Regulatory Update – The New EU Medical Device Legislation

Regulation (EU) 2017/745 on Medical Devices

The EU Medical Device Directive is being amended.

The change in regulation repeals Directives 90/385/EEC and 93/42/EEC and becomes effective from 25 May, 2020, with some exceptions – outlined in Article 122.

Whilst the existing directive has been in place for nearly 20 years, there have been many scientific and regulatory advancements during this time; thus, warranting this update to comply with present requirements.

There is currently no global standard for the classification of Medical devices, with Medical devices in the EU being classified according to their intended purpose and their inherent risks (classes I, IIa, IIb and III) – all of which typically determined by the degree of invasiveness for the specified device.

The new legislation was approved on the 25th May, 2017 and the timeline for its formal introduction will be the 26th May, 2020.

On this date, all of the changes made to requirements will become law and, consequently, all manufacturer processes must have been amended, together with new processes introduced, in order to be compliant.

PharSafer Comment:

PharSafer has analysed the new legislation and determined the necessary changes that the new regulations will bring and, between now and the introduction of the legislation, we will be sending out detailed updates to all of our clients, specifying what will be needed to be compliant with the upcoming new regulations.

Our staff are also being trained in preparation for the many upcoming changes and, in preparation for the 2020 deadline, PharSafer, with its sister company SaPhar, will be launching an additional training course for industry personnel seeking further information about the changes, from the old to the new legislation, and how to perform the new activities in order to be compliant.

Stay tuned for further announcements!

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