Under IMed's Lens - April 2023

Our April blogs ??

News and views from Medical Technology UK 2023

Medical Technology UK?in Coventry is the exhibition and learning place for medical device engineers in the UK, and?the team at IMed Consultancy could not miss out on this key opportunity to mingle with specialist suppliers and catch up with industry friends and partners!

In addition to typical requirements such as?#QMS?or?#CEmarking?support, we found that some burning issues still dominate, specifically?#Brexit, the?#EUMDR?and?#IVDR.

Find out more from the trades show in this?blog by Al Mills !?

PMS and patient safety: shifting to a proactive approach

Need to get key compliance processes such as Post Market Surveillance (PMS) into shape but don’t yet have Notified Body (NB) support? Don’t miss our blog dedicated to this subject, where our team of experts focuses on how to support these “orphaned” manufacturers in updating their PMS to promote and maintain their position on the market.

You can find it here.

Key steps to Post-Market Surveillance (PMS)

If you are thinking about expanding and selling into other international markets then the second instalment of the three-part series on expansion into new markets by?@Daniel English Regulatory Affairs Consultant at IMed Consultancy is a must-read. The second short article of a 3-part series focuses on how to enter the Saudi Arabia Medical Devices market ??

Find out more in our blog!

Medical device legacy status: new definition and requirements

The MDR/IVDR Amendment, Regulation 2023/607 (Transitional Provisions)[1] was published on 20th March, 2023, and immediately entered into force. Among other things, this amendment now requires manufacturers to take immediate action to avoid losing their medical device legacy status.

Preserving the legacy status of a medical device might make the difference between commercial success or failure for many manufacturers that should start preparing to submit a MDR certification application right now to avoid potential bottlenecks closer to the May 2024 deadline.

Find out more here.

Are your non-medical purpose products about to fall under the scope of the UK MDR?

The MHRA intends to bring certain aesthetic and some other non-medical purpose products under the scope of the UK MDRs for the first time, where the product function and risk profile are seen as similar to medical devices.

In this short article @Matt Burton, Strategic Development Director at IMed Consultancy, takes a deep dive into: regulatory classification, UK MDR regulations, scope and examples.

Find out whether your products may be affected in our blog.

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In other news…??

? We’ve launched a new website! ????

We’re seeing a surge in demand for UKRP services, so much so that we’ve set up a UKRP-focused website reviewed and developed by our team of experienced UK regulatory professionals, to shed light on all your concerns, answer all your questions and offer you free resources.

Visit our new website and contact us for experienced, UK-based UKRP services for your Medical Devices and IVDs!?https://ukrp.org/

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? On May 18th we’ll host our first webinar: “Taking your medical device to the US – it’s not as hard as you think”! At 12PM GMT, @Tim Bubb, Technical Director at IMed, will be joined by @Kevin Maleck, Director of Economic Development and International Trade for the City of Mentor, Ohio, in association with @Medilink Midlands, to debunk some myths and reveal how a different approach to regulation need not mean it’s more difficult to get products on the market.

Don’t miss it! Join us here: https://www.dhirubhai.net/events/7057239555967451136/

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? On May 25th, @Tim Bubb, Technical Director and @Al Mills, Business Development Director, are presenting on the “Product Development & Protection” and will take you through the key steps to design and protect your innovation to ensure regulatory compliance. This workshop is part of @TBAT’s Innovation Challenge. You can find more about this awesome initiative and register here: https://tbat.co.uk/the-innovation-challenge/

? On June 7th and 8th IMed Consultancy will be attending MedTech Innovation EXPO with HealthTech Enterprise at NEC Birmingham!

You’ll find IMed’s team at stand C59, Hall 2 or you can book 15 minutes with us here: https://calendly.com/imed365/medtechinnovationexpo

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? On June 20th, you’ll find IMed’s team at HealthTech Integrates, a one-day gathering of technology, diagnostics, devices and therapeutic organisations, as well as clinicians and regulators, that provides the perfect platform to discuss the major challenges impacting the HealthTech sector!

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Let us know if you are attending one of these events, and please come and say hello if you spot us!

[1] MDR/IVDR Amendment, Regulation 2023/607?(Transitional Provisions)?