In
May 2017, the European Commission voted to approve new Medical Device Regulations. This will result in widespread changes in how devices are manufactured, the level of compliance and clinical data required to bring them to the European market.
This is the most significant update of the regulations that govern medical devices in Europe in recent history.
The MDR defines the term “medical device” as any “instrument, apparatus, appliance, software, implant, reagent, material or other article"
The Regulation will affect all medical device manufacturers, importers, Subcontractors/suppliers distributors and EU Representatives.
Transitioning to the MDR is overwhelming and many companies don't know where to start. But with our assistance, experience and network the MDR does not need to be a challenge for your organisation.
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