Its objective is always to protect patients but, when done efficiently, it can also yield a plethora of additional benefits to businesses. Jacob Tyson (pictured), Medical Writer at IMed Consultancy, reports.
As various countries and markets reassess their PMS legislation, it is becoming a key focus for medical device manufacturers who aim to meet this requirement with a transformative mindset that turns burdensome activities into additional value.
For instance, the UK is introducing a new Statutory Instrument (SI) that will increase PMS requirements while the EU has been implementing its EU Medical Device Regulation (EU MDR 2017/745) and EU In Vitro Diagnostics Regulation (EU IVDR 2017/746) with revised and more extensive PMS requirements.
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