Tag: IVDR

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Notified Bodies Survey on certifications and applications (MDR/IVDR)

Last week saw the revised version of the Notified Bodies Survey on certifications and applications (MDR/IVDR) published by the European Commission. [Survey NBs availability (europa.eu)]

While there are still no conclusions made from the results of the survey, it does offer a useful insight on the current state of play for the transition to the MDR for medical devices and IVDR for in-vitro diagnostics.

The challenges the industry has faced to achieve compliance to the new regulations has been widely discussed [refer to previous blogs], resulting in continued delays to the implementation of the regulations, based largely on the state of readiness of the regulatory infrastructure of the EU system.

The regulation has been designed “to ensure the smooth functioning of the internal market as regards in vitro diagnostic medical devices, taking as a base a high level of protection of health for patients and users, and taking into account the small and medium-sized enterprises that are active in this sector.”

From <https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0746&qid=1685433681978>

 In reality, the challenge for SMEs to comply to the new IVDR is great, given the additional data burden, time, and money required to obtain a CE mark. I have often wondered if the EU market is a step too far as a 1st launch country for SMEs, over the opportunity of US market access – and the UK (if the regulators can identify a pragmatic approach under IDAP).

It is therefore an interest to see the graph shown in the report:

The survey highlighted that the NB have SMEs as their main clients for conformity assessment, this is a positive message in that SMEs are still preparing for IVDR compliance, and it will be interesting to see how the implementation of IVDR is achieved for small and medium size businesses.

Here at IVDeology, an immediate question that came from the information above is that the definition of SME encompasses a large number of organisations but internally the teams can vary in size, and the ones we commonly work with here at IVDeology would be at the lower end of the scale. It would be good to know the spread of size of SME’s out there so that we can understand the landscape and dynamic of those hoping to grow.

IVDeology works throughout the whole IVD industry, including supporting SMEs along their path to compliance. For further information on how we can support you, contact [email protected]

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IVDeology Partners with MedBoard

Cutting through the Regulatory Noise: Our new partnership with MedBoard

It seems that the medical device regulatory world has gone into overdrive in the last few years. The rate of regulatory change and the demand for clear guidance around them has substantially increased, especially when you focus on the European Union and the UK which are th key areas IVDeology specialise in. It is now getting to the point where one regultory expert simply cannot know everything they need to know, and this is without the peripheral requirements of REACH, CLP, Sustainability, Environmental and Digital. The need to find the right information from a trusted source has never been so important, as well as in a timely manner.

Our Regs Consultant Fiona Thompson commented the following:


“When I left my previous role to start at IVDeology, finding relevant, correct regulatory updates was one of the things I found most challenging. Having come from a large company, this was all done at a Corporate level and at our site we found out information from notifications or changes to the Global procedures sent out. Out of this corporate world, the places I knew where to look for information had all disappeared and trying to find all the potential websites to set up personnel alerts, I will be honest, was very painful – and I’m still sure I haven’t found them all.”

Even from the early days of IVDeology, the aim was to develop a strong team connected to a wide and diverse industry network, which would help us inform our customers on any Quality and Regulatory updates relating to IVDs and Medical Devices. We do this knowing that many of our SME customer don’t have this network themselves and getting the right information can be a very difficult and time-consuming thing.


Recently we have started using a system called MedBoard – and what a game-changer this is!


“MedBoard is a dedicated search engine for the sector. You can set up customised reviews with relevant key words to keep up to date with new regulatory news in specific countries that you are interested in as well as conduct searches for PMS, literature searches etc. It also sends you email alerts when new information is released. What MedBoard does is provide you with a starting point for regulatory intelligence, based on trusted resources, this allows you the opportunity to build your understanding and supplement your existing knowledge network.”

How do we use MedBoard to support our customers?


IVDeology have used the MedBoard subscription services since early 2023 as we personally find the subscription beneficial to cut through the noise and share the industry updates that are tailored and beneficial to our customers.
IVDeology is proud to funnel information down to our customers and recommend MedBoard’s services and be able to add:

a) timely regualatory updates from a trusted source
b) offer insights on the impact of these updates, using our in-depth knowledge of the IVD indsutry

The outcome for this is to give you the ability to make informed decisions, develop strategies and mitigate changes to the IVD industry relevant to your devices and markets.

At IVDeology, we don’t believe these is a one size fits all model for what we do, as we are committed to helping you in the way that works best.

We’re happy to be able to share updates from MedBoard and put you in touch if you wish to sign up individually as a company to be able to personalise the package at which level you wish, as MedBoard offer several layers of package support depending on budget and need including a new artificial intelligence scanning tool as well as software Validation documents approach for QMS/GxPs processes overviews.

IVDeology adds a layer of support to help explain and discuss the updates and how this may affect your company, teams and projects. This sits well alongside our existing compliance services including UK Responsible Person (UKRP), Person Responsible for Regulatory compliance (PRRC), training, ad-hoc and project support. You can find more about these services on our website.


And to support one step further, IVDeology have a certified team of Quality experts in ISO9001 and ISO13485 to help with implementation of QMS systems and remediation, including software validation.


We don’t make anything from sign ups, we just really think the tool is an excellent creation, and side by side we can create a support system of clear updates whilst also breaking it down into easy digestible actions which saves you valuable time.

For further information or a demonstration on how we can help you, please book a call with Casey or drop us an email at [email protected] to know more.

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MHRA update for future MDR and IVDR

The MHRA held a webinar on March 5th to give an insight into the plans for the future UK regulations for medical devices and IVDs.

The key points for IVDs they made are:

· The definition of IVD will be extended to mirror the definition in the IVDR.

· Devices will be classified into 4 groups, A-D, using a risk based approach. Device classification will follow the IMDRF guidance N64 document – Principles of In Vitro Diagnostic (IVD) Medical Devices Classification, with a couple of UK specifics:

o Devices which monitor infectious loads of life-threatening infectious diseases will be classified as Class D

o Devices with the intended purpose for screening, detecting or diagnosing either neurodegenerative diseases or cardio vascular diseases will be classified as Class C.

Accessories, Independent Software and Companion diagnostics will be classified in their own right. Software that drives a device, calibrators and controls will be classified in the same group as the associated device.

· The Essential Requirements will be updated to generally align with the GSPR under IVDR with differences to reflect the UK specific legislation & national bodies.

o This includes alignment for the requirements for labelling and instructions for use.

The take home message we took away was that they are trying to harmonise with the IMDRF model and the EU IVDR wherever possible to try and reduce the burden on manufacturers whilst still ensuring that the devices on the GB market are safe and effective for users and patients.

Whilst this is good news for manufacturers as a whole and for many they may see very little difference between the UK and EU regulations. However for other manufacturers their devices may end up being classified differently in each regulation. What potential challenges may these differences in classification cause?

As the essential requirements will align, the impact for the technical file will hopefully be minimal. And following the IMDRF model may have advantages too – aligning with other key markets such as Canada and Australia. However differing classifications may have an impact on Post Market Surveillance and whether a PMS report or a Periodic Safety Update Report is required. It may also give notified bodies/UK approved bodies more work as they will have to consider how the differences in classification impact their role. What may the impact on market access be if we diverge from the EU when we know our market are closely linked? We would love to hear some thoughts.

Written by Fiona Thompson – RA specialist at IVDeology

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Updated classification for SARS CoV-2

Recently we saw Team-NB release a Position Paper on the Classification of devices intended to detect SARS-CoV-2. There has been a lot of discussion about whether SARS-CoV-2 IVDs should remain classified as a Class D under the requirement of detecting a transmissible agent that causes a life-threatening disease with a high or suspected high risk of propagation. The Team-NB Position Paper is that this classification should be re-assessed based on the facts that there are effective vaccines available, currently no circulating variants of concerns and evidence that the current circulating variants within the EU indicate no increased impact on immunity or severity for the general population.

There are two possible re-classification routes that are suggested:

· Class B – under rule 6 – devices not covered by the other classification rules.

· Class C – under rule 3c – devices where there is a significant risk that an erroneous result would cause death or severe disability to the individual, foetus or embryo being tested, or to the individual’s offspring.

Team-NB’s position is that Class C should be recommended due to the potential remaining risk for vulnerable populations and the limited data available for the post-pandemic phase. This would also ensure that stricter PMS & Performance Evaluation/Clinical Evidence requirements are applied for these devices.

This could be welcome news to manufacturers of these devices. We will need to see if this leads to a change in the MDCG guidance – watch this space!

Team-NB-PositionPaper-Classification-of-SARS-Cov2-20240202.pdf

Written by Fiona Thompson – Regulatory specialist at IVDeology