Category: IVD & MDR NEWS

Posted on by

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]

Posted on by

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.

Posted on by

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

Posted on by

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

Posted on by

Urgent action needed to prevent widespread shortage of diagnostic test

On the 16th January, Biomed Alliance published a statement on “Urgent action needed to prevent widespread shortage of diagnostic tests”

BioMed Alliance – Statement: Urgent action needed to prevent widespread shortage of diagnostic tests (biomedeurope.org)

For anyone not aware of the current challenges facing the EU (and UK) IVD sector, it is well worth a read. The summary especially provides a really fantastic series of measures which are well worth thinking about. 

Their recommendations are: An urgent extension of the transition periods for all IVD classes will provide much-needed breathing room to the sectorEUDAMED must be fully implemented and widely used as soon as possible Special regulatory pathways to facilitate the conformity assessment of rare/niche/orphan IVDs should be created Additional efforts are required to raise awareness, and to provide support and guidance for IVD manufacturers, and particularly SMEs There is a need to simplify the re-certification of legacy devices, that have been successfully on the market without safety issues for a number of years There should be a legislative requirement for manufacturers to report to laboratory professionals and regulators when they intend to take an IVD or medical device off the market at least 6 months prior to withdrawalWhile, In-house IVDs (IH-IVDs) could fill the “CE gap”, Article 5.5, including the requirement of no equivalence to CE-IVDs, discourages their development due to the additional administrative burden and uncertainty of sustainability for IH-IVDs.

From my experience, we need to raise awareness, focusing on, but not limited to SMEs, as they will face the biggest challenge in compliance to the IVDR. 

Without making sweeping statements, I feel that it is not a question of SMEs won’t adopt IVDR, it is a case of SME’s don’t have the resources to make that significant jump to compliance. 

Given the additional competency, internal mechanisms required for understanding the new requirements, collecting and reviewing clinical evidence and maintaining this, SMEs struggle to gain sufficient investment, or sustain cash flow to support the 3 year + process of IVDR compliance. We have seen that the journey to compliance is possible, including for SME’s. However to do this requires a good understanding of what is required, a focused team and early planning to ensure that the key timelines are met.

We would encourage any IVD manufacturer, SME or not, who is looking to achieve CE marking to make contact with us. The more we are able to inform, encourage and engage with the industry, the more chance the industry has of preventing diagnostic test shortages.

Posted on by

IVDeology turns 6 years old!

Today IVDeology is 6 years old! With the knowledge of impending redundancy Stuart and I (Nancy) started the business that would grow to be who we are today. When we celebrated our first birthday in January 2019 we had no idear how our company woud grow over the coming 5 years or the amazing in vitro diagnostic designers, developers and manufacturers we would encounter and have the privilege to work with. 

So what have we achieved in our first 6 years?

IVDeology has grown to be a team of specialists who all work sharing our values Friendly, Flexible and Supportive.

We have built our Quality Management System which has just been recertified to ISO9001

We have worked with companies to deliver quality management services

o MDSAP Gap analysis/audit readiness

o ISO 13485 internal audits

o Building QMS systems to passing certification

o ISO13485 focussed training

o Audit support

We have worked with organisations who needed to add to their skills to meet the challenges of transitioning to comply with IVD Regulation 2017/746

o Gap Analysis

o Scientific Validity Reports

o Performance Evaluation Plans

o Performance Evaluation Reports

o Building Technical Documentation ready for review

o Group training events

o Company specific workshops – ask us anything

o One to one mentoring and upskilling

o Providing the Regulatory or Quality service until they onboard their own resource.

In 2020 we opened IVDeology UKRP Ltd to meet the neeeds of manufacturers outside the UK meet the requirements introduced by the UK MDR

So what changes have we seen in our 6 years of operation?

  •  The continuing development of the UK regulatory framework, having Stuart working within BIVDA on the Executive Committee and as Chair of   the Regulatory Affairs Working Party gives first hand experience of those developing changes
  • Regulatory deadlines have come and gone and been extended/modified and industry has had to adapt – we will continue to support in the transition
  • Covid – This hit the IVD industry hard both during and after. Opportunity and distraction
  • The accelerated development of AI into the IVD industry, we have a software regulatory focussed specialist on the team to support those developers needing regulatory advice.
  • We have entered into some strategic partnerships to provide our customers with access to EU Authorised Representatives, Swiss Responsible Person support, Electronic quality management system software

We’d like to say thankyou to our team, past, present and extended and all of the amazing people and organisations we’ve had the pleasure of working with and continue to work with. We look forward to the next years adventures, we’d love to work with more of the industry so please do come and have a chat, no need is too small or too big – book time in with us by click here 

Posted on by

Regulatory Roadmap announced for Medical Devices

The MHRA have published a roadmap today which outlines the intended timelines for delivering the future regulatory framework for medical devices. Below is an Initial breakdown of the roadmap 

There are 5 key areas of the roadmap, broken down into:

1- Implementation of future regulations

The breakdown ensures patients have access is to life changing devices and tests and introducing them safely and within regulatory compliance, in a way that also continues to showcase the UK as being attractive to medical innovators. It is intended that priority measures to enhance post-market surveillance will be put in place first in 2024, with core elements of the new framework expected to be in place in 2025.

2- Transitional agreements

It has introduced legislation which provides that CE marked medical devices may be placed on the Great Britain market to the following timelines:

  • general medical devices compliant with the EU medical devices directive (EU MDD) or EU active implantable medical devices directive (EU AIMDD) with a valid declaration and CE marking can be placed on the Great Britain market up until the sooner of expiry of certificate or 30 June 2028
  • in vitro diagnostic medical devices (IVDs) compliant with the EU in vitro diagnostic medical devices directive (EU IVDD) can be placed on the Great Britain market up until the sooner of expiry of certificate or 30 June 2030, and
  • general medical devices, including custom-made devices, compliant with the EU medical devices regulation (EU MDR) and IVDs compliant with the EU in vitro diagnostic medical devices regulation (EU IVDR) can be placed on the Great Britain market up until the 30 June 2030.

This will enable certain CE marked medical devices to continue to be placed on the Great Britain market for longer.

The legislation provides that you can place self-declared CE marked Class I medical devices on the GB market beyond 30 June 2023 if they are:

  • self-declared against EU MDR requirements (until 30 June 2030), or
  • self-declared against MDD requirements before 26 May 2021 where Notified Body involvement in their assessment is not required under MDD but is under EU MDR (until 30 June 2028). This includes upclassified devices and reusable surgical instruments.
  • It also provides that you can place a Class I medical device which has a sterile or measuring function with a valid MDD certificate on the GB market until 30 June 2028.
    Class I medical devices and general IVDs under the Directives, for which the conformity assessment under the EU MDD or EU IVDD did not require a notified body, can only be placed on the Great Britain market if the involvement of a notified body would be required under the EU MDR or IVDR (i.e., if it is an upclassified device or a reusable surgical instrument Class I device). Custom-made devices that are compliant with the EU MDD or EU AIMDD can no longer be placed on the Great Britain market.

(Information above taken from GOV.UK website as of 9/1/2024)

3- Post Market surveillance requirements

The government have also introduced a list of requirements for manufacturers of devices for their post market surveillance once on the market (also known as PMS) in hopes to improve patient safety. The WTO website states that it intends to provide;

  • Detail on what must be included as part of a PMS system, including the methods for collecting PMS data to support improved capturing of PMS data and harmonisation across manufacturers.
  • Enhanced serious incident reporting obligations for manufacturers to support the detection of safety issues sooner.
  • More stringent requirements for manufacturers to conduct periodic reviews of their PMS data, including for implantable medical devices. This aims to support manufacturers in earlier detection of trends/signals that may have an impact on the safety of a medical device.

4 – Future core regulations

During 2024, stakeholder discussion groups will be held to give early insight of the regulation policies of the future core regulations which will include:

– Ensuring devices have a unique device identification number (UDI)

– Improvements for implantable devices (class lll)

– Strengthening of QMS 

– Changes and updates of class devices including those acting as software as a medical device (SaMD) as well as cyber security requirements and AI software in line with those in the EU

– New requirements for clinical investigations

– Requirements for a Qualified Person within regulatory internally in the company

– Requirements for intended purpose statements to align with their device

We will continue to monitor the updates as and when they are released, but any queries or questions about the above updates can be submitted to us via [email protected] or you can book time into our calendar and chat with our friendly team about how this will impact your business – get in touch here

Posted on by

IVDeology Partner with Clinical Research Organisation PeploBio

IVDeology are excited to be partnering with PeploBio, a clinical research organisation (CRO) based in Cambridge, UK. IVDeology believe we can share the load within the Medical and diagnostics industry, and partnering with trusted companies to offer a more holistic offering to our customers in areas we do not offer. Clients with IVDeology who need CRO or clinical diagnostics support can now be referred to the PeploBio team, and those looking for Quality, regulatory or UKRP services can be referred to us from PeploBio.

Our partnership will work in tandem to support our customers and clients supporting smoothly with open communication between the two. IVDeology and PeploBio have teamed up after careful consideration regarding our passion and ethos, including being friendly and committed teams that are focused on our customers projects success and both tailor our services to benefit and support our customers in the best way fitting their needs. 

If you are looking for CRO support including clinical testing, please get in touch and we can put you in direct contact with the PeploBio team.

You can book to speak with us here via our contact page

Posted on by

Meet IVDeology at Medica 2023

IVDeology Ltd are headed to Medica 2023 after a successful (but rather tiring!) 2022 expo with Medilink UK

What is Medica?

MEDICA is the world’s leading trade fair for medical technology, diagnostic imaging, health IT, laboratory equipment, diagnostics, physiotherapy equipment and medical consumables held in Dusseldorf, Germany. Year after year it attracts thousands of visitors from all over the world. MEDICA offers a wide range of opportunities to find out about the latest trends and developments in medical technology. Here you can meet leading experts and decision-makers in the medical industry and benefit from their knowledge. The trade fair offers a unique platform for the exchange of information, experience and ideas from the entire medical supply chain.

We will be attending with Medilink UK and you can come meet us in Hall 16 at the Medilink UK Pavilion, stand H10-4 where you’ll be able to learn more about IVDeology and the team, how we would be able to add benefit in your companies compliance journey in a way that suits you, and also pick our brains on all things Quality and regulatory within MDR and IVDR.

We will be exhibiting the 13-16th November 2023, and you can drop us a message on Linked in or via [email protected] to book in some time, or simply drop by the stand and say hello! We’re there to support you.

Our MD and founder Stuart Angell will be attending alongside our Customer success and marketing coordinator Casey Sedgwick

There is still time to sign up to exhibit and network with the exhibitors, as well as attend conferences and free industry talks here: To the ticket shop (messe-duesseldorf.de)

We look forward to connecting with new and old friends, colleagues and customers.

bis bald! (see you soon)

Posted on by

Innovative Device Access Pathway – Breaking it down

Breaking down The new Innovative Devices Access Pathway (IDAP) initiative – what we know so far

The MHRA have hosted a couple of webinars over the last few days about this new initiative and the IVDeology team joined and came together with their top take aways from the webinar. Here are some of the main points that were raised:

IDAP is designed to provide a pre-regulatory pathway to allow new medical technologies that address an unmet clinical need to get on the market quickly without compromising patient safety.

Currently in the pilot phase, 8 varied technologies will be selected to embark on this pathway. Diagnostics devices and SaMD (including AI) were called out as areas that will be considered. As well as addressing unmet clinical needs, the economic viability of a project, how affordable it is to the taxpayer, how wide a population it could benefit and how accessible it is for patients will be taken into consideration as part of the selection process. 

The IDAP pilot was launched on 18/09/23 and applications are invited via the MHRA website until the closing date of 29/10/23. Subsequently, the 8 technologies will be selected in December 2023 and discussions to develop Target Development Profiles (TDPs) for these technologies will take place between Jan and Apr 2024.

Please note that there is a 2-hour window in which to complete an application, and there is no ‘save’ facility. It is therefore recommended that the guidance is read through carefully first and some preparation work is done in advance of completion.

The aim of IDAP is to provide a streamlined approach to getting exciting new technologies on the UK market utilising a partnership between the MHRA, Health Technology Wales (HTW), the National Institute for Health and Care Excellence (NICE) and the Scottish Health Technologies Group (SHTG). The selected companies will have early conversations with decision-makers which will be extremely beneficial to the success of their product in the long-term.

A range of tools will be available to those companies that get accepted onto the pathway, covering areas such as:

  • Joint scientific advice to create a clinical development plan.
  • A service to support innovator engagement with clinical investigation.
  • Help with auditing of QMS to ISO 13485 standards.
  • Support to help innovators navigate the pathway.
  • An access forum to facilitate access of the technology into NHS use.
  • Where deemed appropriate by the MHRA and, once a clinical investigation trial has been conducted over a 6-month period, selected technologies will be granted early market access via an Exceptional Use Authorisation.
  • Following on from this, there will support on post-market surveillance requirements, further evidence generation for HTA (Health Technology Assessment) and docking with reimbursement pathways.
  • Just to re-iterate, to be considered for the programme, there needs to be an unmet clinical need for the technology and that it will be a real game changer for patients if it gets on the market quickly. A letter of support from clinicians will be required to that effect as part of the application process. 
  • Consider including within your application any evidence of the sustainable features of your device which may support the NHS ambitious net zero targets. These may be factored in the final selection decisions for otherwise equal applications.
  • The aim is to learn from the pilot as to how this programme will work long-term. It is the start of establishing an end-to-end innovative pathway in the UK and they hope, from March 2025, to have a sustainable system going forward.
  • This is an exciting and forward-thinking programme whose success will ensure that state of the art, innovative medical technologies can begin to benefit patients in the UK much earlier than is currently the case. 

If you’d like more information or support regarding any of the above, such as Quality management system implementation, to being regulatory ready for the market, you can email us on [email protected] or you can book a call via this link to speak directly to our team