Our Blog
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...
Can instructions for use be provided electronically under the EU MDR?
Find out more about the new eIFU Regulation... Regulation (EU) 207/2012 already set out when electronic instructions for use ("eIFUs") could be used for devices conforming to the EU Medical Devices Directive (Directive 93/42/EEC, “EU MDD”) AND the EU Active...
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...
All medical devices sold in the UK MUST now be registered with MHRA
All medical devices sold in the UK MUST now be registered with MHRA It’s a new year, with a new regulatory change to consider. The final legal registration deadline for both medical devices and IVD’s in the UK was 31 December 2021, so all products being sold into the...
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...
MDCG Guidance on Substantial Modification of Clinical Investigation
The latest MDCG Guidance (2021-28) explained Earlier this month, December 2021, the MDCG published a new guidance document alongside an accompanying template. These documents are directed towards the sponsors of a clinical investigation and provide information as to...
Countdown to MD and IVD Registration deadlines… only 24 days to go!
Countdown to UK Medical Device and IVD Registration deadlines … only 24 days to go! Medical device & IVD manufacturers selling their products in the UK must register all devices with UK MHRA by 31st December 2021, to be able to continue to sell them legally in...
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?
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...