Our Blog
Meet Dan English
The IMed Team keeps growing and this week Dan English joined the ranks of our specialist consultants. Al Mills finds out more; Where are you from? I was born in Birkenhead on the Wirral and raised in the north side coastal towns of the peninsula. I spent many...
Regulation (EU) 2022/112 – IVDR Transition Proposal in EU Approved and “set in stone” by the European Parliament
"Set in stone" by the European Parliament On the 25 January 2022, Regulation (EU) 2022/112, amending the transition provisions to Regulation 2017/746 (IVDR) was published by the European Union. The industry was alive to the sounds of a potential “delay” in October...
IMed opens Manchester Office
IMed's Team in the North is growing... Our team has been growing over the last couple of years and in order to bring in the right regulatory talent, we have been casting our net nationwide. There are many Life Science hubs around the country these days too – I’m...
How to increase chances of a successful application with a notified body
The Best Ways to engage with your Notified Body The strain on Notified Bodies during the current climate is monumental. This is having a direct effect on manufacturers being able to sell medical devices, due to fewer notified bodies being designated to the...
Regulatory Surgeries Launch
IMed launches Free Weekly Regulatory Surgeries! Have you ever spent more than an hour trying to resolve an emerging Quality or Regulatory query for yourself? According to IMed’s recent poll, many manufacturers have done just that. Maybe you’ve eventually found the...
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...