March 2024

?? NEW WHITEPAPER ON IVDs ??

We started 2024 with a free new whitepaper on In-Vitro Diagnostics (IVDs)!

The EU has recently proposed an extension to the transitional provisions for certain IVD devices, postponing deadlines once again.

The transitional provisions would be amended as follows:

·?????? Legacy IVDs Class D (IVDR) must comply by December 31, 2027.

·?????? Legacy IVDs Class C (IVDR) must comply by December 31, 2028.

·?????? Legacy IVDs Class B and Class A sterile (IVDR) must comply by? December 31, 2029

However, it’s also important to note that manufacturers need to meet certain conditions to be eligible for extension, such as having applied to a Notified Body at least two years before the compliance date (i.e. September 2025, September 2026 and September 2027 respectively for Class D, Class C, and Class B and A Sterile devices).

The whitepaper analyses the key role of IVDs in supporting healthcare systems with early diagnosis to tackle common and rising diseases and comes at a critical time for manufacturers that still have not started the process of registering legacy devices under the EU IVDR.

“As healthcare is moving towards a more proactive form of prescribing and IVDs are proving to be indispensable tools to enable this, IMed felt the need to draft this insightful paper to explore and highlight the importance of IVDs in this new landscape, aiding manufacturers in the process of achieving compliance.” explains Jonathan Ripley, IVD and MD Consulting Services Director at IMed Consultancy.

MedTech Regulatory Global Pathways – Digital Summit

On February 7th, 2024 IMed’s Strategic Development Director @Matt Burton presented at @MedTech Leading voice’s webinar “MedTech Regulatory Global Pathways - Digital Summit”. Hosted by @Dvaid Filmore, Executive Editor at Market Pathways (MedTech Strategist), the session was aimed at helping manufacturers that want to explore the best markets to launch their products.

Don’t worry if you missed it, you can still watch it here: https://www.dhirubhai.net/events/summit7157151109579440128/about/

The IMed team is growing

We are thrilled to introduce the newest addition to the IMed’s team, Dipty Gadia !

A QA/RA professional with 15 years’ experience in quality management, specialising in medical device quality assurance and regulatory compliance, Dipty brings a wealth of expertise and enthusiasm with her.

Throughout her career, Dipty has demonstrated a profound dedication to ensuring patient safety and the highest quality standards for medical devices. Beyond her professional pursuits, she is passionate about sport and exploring the great outdoors.

International Women's Day 2024: Celebrating women in medtech!

Did you know that women hold less than a quarter of executive roles in medtech? However, the tide is turning. From 18% in 2019 to 23.6% in 2023, we're witnessing a steady climb. While there's still ground to cover, this upward trend signals a more inclusive and diverse industry on the horizon. We're witnessing a surge in femtech startups, essential discussions on representation, and, most importantly, a growing interest among young women to join the sector.

To mark this year’s International Women's Day, Medical Plastics News collected insights from influential women in medtech, including IMed Consultancy Ltd ’s Managing Director and Senior QA/RA Consultant Leeanne Baker .

Read more here: https://www.medicalplasticsnews.com/medical-plastics-industry-insights/medical-plastics-thought-leadership/international-women-s-day-2024/

Live from March’s events

Medical Technology UK 2024

On March 13th and 14th IMed attend Medical Technology UK 2024, an amazing event dedicated to Medical Device Design, Engineering and Manufacturing!

Here’s a few pictures from the event, that has been a fantastic opportuntity to meet partners and clients, proving that networking and good relationships really make a difference!

Andy Coxon ETHOS Ltd , Al Mills , IMed's Business Development Director and Neil Stentiford Soe Health Ltd

Al Mills , Darren Clarke , IMed’s Sales Soordinator and Timothy Bubb , IMed’s Technical Director.

German MedTech SME Trade mission?

On March 14th IMed’s Strategic Development Director Matt Burton attended this interesting trade missionevent in London organised by Trade Horizons Limited

A day filled with industry news & speakers, great MedTech products & equipment and the chance to meet a trade delegation of German Med Tech businesses committed to doing business in the UK

Surgtech

March 22nd and 23rd? our Business Development Director Al Miller was at #SurgTech2024 - Innovation Across the Surgical Pathway, in Leeds.

A thrilling two-day event that brought together clinical academics, health professionals, researchers, methodologists, public and patients, industry, and experts in market access, medical device regulation and commercialisation!

In the picture, Richard Hall MSc, BA(Hons), CMgr MCMI, FRSA Pd-m , Al Mills and Andrew Davidson Pd-m .

Our March blogs ??

Deep Dive in the Asia Pacific Medical Device Market – Japan

Our articles dedicated to emerging market access continues. This time we’ll explore Asia Pacific further, and this episode is dedicated to Japan.

Find out more about all the options you have to enter the Japanese market depending on your devices’ classification on our blog!

Best foot forward: Which market to enter first?

We’ve started a new blog series dedicated to International Market Entry!

IMed’s team will look at three major markets for medical devices- the EU, the UK and the USA- highlighting some key considerations relating to entering each of these geographies “first” to help manufacturers make informed decisions and successfully expand the global presence of their products.

This first of four instalments is dedicated to the current global regulatory scenario and its opportunities: https://imedconsultancy.com/best-foot-forward-which-market-to-enter-first/

In other news…??

? On April 16th ?IMed’s Managing Director and Senior QA/RA Consultant Leeanne Baker and Darren Clarke , our Sales Coordinator will be at TBAT Innovation Ltd ’s Partner and Pastries networking event at Charnwood Campus Science Innovation and Technology Park .

? On May 9th IMed’s Al Mills , Timothy Bubb and Jade Fraser will present a regulatory workshop for HealthTech Innovators at 英国莱斯特大学 .?

The workshop has the aim to help new innovators decide on key regulatory product development steps necessary for technologies used within a healthcare setting. There will be a particular emphasis on development of software and AI applications relevant to health.

To register your interest and any particular questions/areas that you would like to focus on, email [email protected]

? On May 9th IMed will attend Medilink Midlands Business Awards at Athena in Leicester. We’re looking forward to this evening, celebrating with friends and colleagues!

TBAT Innovation Ltd Jo Rudzki Esther Lawrence Sam Stephens Ian Davie Smallfry Design Kelly Myall-Chance Steve May-Russell

? On May 22nd IMed’s Business Development Director @al mills and Technical Director @tim bubb will be presenting TBAT Innovation challenge’s workshop “Product Development & Protection – Design and protect your innovation” with Sam Stephens , Director – TBAT Innovation Ltd , Andy Last , Lead Industrial Designer – OPD (Oxford Product Design) , Neil Carter , Managing Director – Ignys Ltd , Henry Foxhall, PhD CEng FIMMM , Senior Consultant – Conformance Limited , Dr Jagvir Purewal , Partner – Forresters , Gregory Smith , Senior Associate – Forresters and Ed Wright Partner – Shakespeare Martineau .

This workshop is designed to delve into the innovative solutions you need to know to fund your business growth. The speakers will discuss problems, challenges and highlight opportunities to reduce the effects of product design and protection barriers – supporting you on your journey to commercialisation and being a disrupter in the marketplace.

Register for free here: https://www.eventbrite.co.uk/e/ic24-product-development-protection-design-protect-your-innovation-tickets-816498568197?aff=oddtdtcreator

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? On June 5th and 6th IMed’s team will be at MedTech Innovation Expo at NEC in Birmingham. Bringing together leaders, engineers, innovator and manufacturers, as well as technology and innovation, this is a key event for the medical device market workldwide!?

On the 6th our Technical Director Timothy Bubb will be presenting the session “New frontiers: Regulating AI in medtech”.

Don’t miss it!

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? On June 10th and 11th Al Mills and Leeanne Baker will attend FemTech Lab ’s conference “Decoding the future of women” in London.

This 2 day conference, held during London Tech Week, will focus on innovation in Women's Health and Wellness.

? On June 12th IMed’s Business Development Director Al Mills will be at TBAT Innovation Ltd ’s Partner and Pastries networking event at the Old School House in Wolston, Coventry.

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