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Whose Claim Is It Anyway?

Whose Claim Is It Anyway?

Intended Use and Clinical Claims under the New EU Regulations “My partner claims that vacuum cleaners are much better for cleaning floors than a brush. Personally, I think that’s a sweeping generalisation …”Indeed.   A rather less sweeping generalisation, however, is...

New Update to MHRA Guidance

New Update to MHRA Guidance

  New update to MHRA Guidance – Notify about a clinical investigation for a medical device 4th January 2022 saw new guidance on how to notify the MHRA about a clinical investigation for a medical device. The guidance is aimed at manufacturers who need to carry...

How is Your Device Used?

How is Your Device Used?

Intended Use versus Indication for use – what’s the difference? Since these terms entered the regulatory landscape, the difference between “intended use/purpose” and “indication for use” has frequently given our clients cause for consternation. Although the...

Ellie Mills Joins IMed

Ellie Mills Joins IMed

Meet Ellie Mills Where are you from? I was born in Watford, but I’ve lived in the Cotswolds for the last 12 years. I’ve also lived and worked in Mallorca for a couple of years, which I really love and regularly go back to, but now just for holidays! What were you...

Changing your MDD certified medical device? What next?

Changing your MDD certified medical device? What next?

Got a change to make to your MDD certified medical device? What next? For many manufacturers of medical devices, change is often the only constant. Sometimes this change comes from a desire for product enhancement, providing new features to improve patient outcomes or...