15 things you need to know about the Medical Device Regulation

Three Circles has published an updated list of things you need to be aware of about the Medical Device Regulation

While the detailed MDR text is of interest to people working within regulatory affairs, everyone else probably wants to find out “what does it mean for me?”

So, here are 15 things you need to know about the MDR:

Thing 1.

You will need to consider how your device / technology / combination product is managed throughout it’s life-cycle, as the MDR proposes a broader focus than the pre-approval view taken by the Medical Devices Directive. This means that you will have to follow up on quality, performance and safety of devices after they are placed on the market

Thing 2.

Catching up with the Pharmaceutical regulations, where the role of the Qualified Person has been required for some years, you’ll be required to have a “responsible person” within your organisation, to safeguard regulatory compliance

Thing 3.

Unique Device Identifiers will be introduced, similar to the system in place for the US market

Thing 4.

The role of your Notified Body will…

[click here to read the full article, on Three Circles website]
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