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Technical documentation for IVDR

Before manufacturers can places in-vitro diagnostic medical devices (IVDs) on to the European Market for commercial use, they must meet the requirements of the European IVD Regulation – IVDR (2017/746/EU), and obtain a CE mark. The manufacturer must demonstrate that the product is safe, effective and meets the relevant regulatory requirements. This is done by preparing a series of technical documents.

What comprises Technical Documentation under the IVDR?

In Vitro Diagnostic (IVD) Technical Documentation is a crucial part of the regulatory process for IVD devices. It demonstrates conformity to the General Safety and Performance Requirements (GSPRs) according to the Annex I of the regulation. The documentation must reflect the current status of the IVD medical device through the application of the manufacturer’s Quality Management System (QMS). The GSPR covers 3 broad areas, described within 3 chapters:

  • General requirements
  • Requirements regarding performance, design and manufacture
  • Requirements regarding information supplied with the device

The layout of the Technical Documentation required for the IVDR is much more defined compared to the previous approach under the IVD Directive. The manufacturer is required to compile the documents in line with the requirements of Annex II (technical documentation) & III (post market surveillance). The structure laid out in Annex II allows a more consistent approach for creating technical documents for IVDs, with sufficient ability to include or exclude (with sufficient justification) some elements depending on the specific nature or intended purpose of the device.

Once these have been met, the manufacturer can then draw up a Declaration of Conformity stating that the device is in compliance with the relevant regulation. For higher risk classes B-D, this will be done on completion of a Conformity Assessment process performed by an EU Notified Body.

What are the requirements?

The file shall include the following sections (these are the main headings in Annex II:

  • Device Description and Specification
  • Information Supplied by the Manufacturer
  • Design and Manufacturing Information
  • General Safety and Requirements (Annex I)
  • Benefit-Risk Analysis and Risk Management
  • Product Verification and Validation

The data above is required to be presented in a clear, organised, readily searchable and unambiguous manner, so that the documents can be easily read and understood. The aim of the technical documents are to provide a reader with a narrative of how the device has been designed and developed and is safe and effective when used as intended.

In most cases, the documents shall be presented to the notified body (for a class B, C and D device) electronically, so it would be advantageous to prepare and hold all documents electronically, ideally within a dedicated electronic Quality Management System (typically compliant to ISO 13485)

What data do you need to provide?

While some elements of the Technical Documentation is well defined, for example, you must provide all labels and instructions for use in the applicable languages of the European Union, much of the content can vary depending on the function, technology and intended purpose of the device, as long as the basic structure of the table of the contents remains consistent to Annex II.

When compiling your documents, it is well worth understanding any specific requirements based on how the device is used, e.g. if a self-test or near patient test, or with an integrated software element, as this will require additional information to be provided. It is also recommended to discuss your technical documentation layout with your notified body, who may have published specific guidance in how the documents should be presented. In addition to this, refer to guidance from Team AB (the European association of Medical Device Notified Bodies).

Final Thoughts

Both manufacturers and Notified Bodies have an interest to ensure a speedy technical review period. The closer Manufacturers align with the structure of Annex II, provide sufficient evidence to demonstrate conformity in a way that can be easily understood, the quicker (and cheaper) the review process will be.

It should also be remembered that the IVDR technical documentation acts as an iterative and traceable record telling the story of the history of the device. An effective, well-constructed technical file can be of huge benefit when retrospectively reviewing design changes, post market surveillance and risk management for your devices.

IVDeology is ideally placed to support IVD manufacturers in the completion of technical documentation to support CE submission. We have a successful and established process of building template structures, gap analysis and implementation. For any support required for CE marking, please contact us for a chat by clicking here

Written by Stuart Angell, MD and founder of IVDeology Ltd and IVDeology UKRP Ltd

#MDR #IVDR #diagnostics #technicalfile #techfile #invitrodiagnostic #cemark


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Acquisition of IVDeology Holdings Limited by Abingdon Health plc

We are pleased to announce that on the 03rd May 2024, IVDeology Holdings Ltd (including IVDeology Limited and IVDeology UKRP Limited) have been acquired by Abingdon Health plc.

About Abingdon Health

Abingdon Health is a leading lateral flow contract research (CRO) and contract development and manufacturing organisation (CDMO) offering its services to an international customer base across industry sectors that include clinical, animal health, plant health, and environmental testing. Abingdon Health has the internal capabilities to take projects from initial concept through to routine and large-scale manufacturing; from “idea to commercial success.”

The Company’s CDMO division offers product development, regulatory support, technology transfer and manufacturing services for customers looking to develop new assays or transfer existing laboratory-based assays to a lateral flow format. Abingdon Health aims to support the increase in need for rapid results across many industries and locations and produces lateral flow tests in areas such as infectious disease, clinical testing including companion diagnostics, animal health and environmental testing. Faster access to results allows for rapid decision making, targeted intervention and can support better outcomes. 

Abingdon Health’s Abingdon Simply Test™ range of self-tests is an ecommerce platform that offers a range of self-tests to empowers consumers to manage their own health and wellbeing. The Abingdon Simply Test™ ecommerce site offers consumers a range of information to support them in making informed decisions on the tests available. In addition, the site provides Abingdon’s contract services customers with a potential route to market for self-tests. The Abingdon Simply Test range is also sold through international distributors and through other channels in the UK and Ireland such as pharmacy chains.

Founded in 2008, Abingdon Health is headquartered in York, England.

For more information visit: www.abingdonhealth.com

Building on Quality and Regulatory Expertise

Nancy and Stuart created IVDeology in 2018 to provide support to IVD Manufacturers throughout their compliance journey, building long term relationships with our customers, suppliers and industry stakeholders. We have been honoured to support many projects throughout the EU IVDR and UKCA transitions, and helped deliver diagnostic tests and IVD accessories throughout the Covid-19 outbreak.

This opportunity builds on the continued growth and success of the IVDeology group providing expert regulatory, quality and compliance services to the in-vitro diagnostic industry. We have always welcomed collaboration with our strategic partners to be part of a holistic approach to deliver end to end support to the industry, from SME and micro businesses to large, multi-national IVD manufacturers. Stuart and Nancy will continue to lead IVDeology as part of the wider Abingdon Health group. We will also continue to work with our existing customers and partners, but be able to offer a wider range of connected services via Abingdon Health in conjunction with the existing Quality and Regulatory services.

Stuart Angell, Managing Director IVDeology commented:

Myself, Nancy and the rest of the IVDeology team are excited to be joining the Abingdon Health Group. The in vitro diagnostics sector is under a significant period of regulatory change in the UK, EU and internationally. By combining our collective skills, knowledge and expertise, we can support our customers and the wider IVD industry with the collective breadth of knowledge that this opportunity provides.

Chris Yates, CEO, commented:

We’re delighted to welcome Stuart, Nancy and the rest of the IVDeology team to the Abingdon Health group. The acquisition of IVDeology is in line with Abingdon’s strategy of providing our customers with all the pieces of the jigsaw required to bring products from idea to commercial success. The IVDeology team will strengthen Abingdon’s existing knowledge leadership and regulatory expertise. We look forward to working with the IVDeology team and supporting existing and new customers in navigating a regulatory environment going through a period of significant change.”

Signed Stuart Angell, MD of IVDeology Ltd

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EU IVDR Transition Update 2024

IVDR Transitional Provisions – Something had to give!

On the 23 April 2024, the European Parliament unanimously approved the proposal to amend the EU MDR (2017/745) and IVDR (2017/746) regarding the gradual roll out of Eudamed, information obligation in case of interruption of supply and the transitional arrangements for certain in vitro diagnostic medical devices (IVDs).

The amendment has been requested by industry to ensure continued access to critical diagnostic products, essential for a smooth running European healthcare system, and offering a hight level of protection to patients and users of diagnostic tests.

Why was change needed?

The IVDR has applied for placing IVDs onto the EU market since 26 May 2022, replacing the existing IVD Directive 98/79/EC, this required that all devices, including legacy devices, must meet a higher level of regulatory compliance. In January 2022, the European Parliament and Council adopted an extension to the transitional arrangement, with extended timelines based on the risk classification of devices:

Risk ClassCurrent deadlines for compliance
Class D (Highest Risk)26 May 2025
Class C26 May 2026
Class B, Class A Sterile26 May 2027
New devices, Class A (Lowest Risk)26 May 2022 (No extension)
Devices used in Healthcare Institution26 May 2028

The original transitional extension was intended to ease the pressure on implementation issues and delay experienced with infrastructure (including Eudamed), Notified Body availability and manufacturing readiness, all of which were impacted by the Covid-19 outbreak.

While the transitions had allowed some breathing space, the industry is facing an uphill struggle to be ready to meet these dates.

What is changing?

  1. Further transitional extension for some devices

With the exception of legacy devices that do not require conformity assessment (Class A and devices used on Healthcare Institutions), additional time is being added to the transition time for IVDR, and existing devices can continue to be placed on the EU market until the following dates:

Risk ClassCurrent deadlines for compliance
Class D31 December 2027
Class C31 December 2028
Class B, Class A Sterile31 December 2029

To use these timelines however, manufacturers must comply with certain conditions including:

  • The devices are CE marked under the IVD Directive,
  • There are no significant changes to the design or intended purpose,
  • A Quality Management System compliant to IVDR shall be put in place by 26 May 2026,
  • A formal application shall be lodged with a notified body 2 years prior to the dates above.

2. Bringing forward the mandatory use of Eudamed

The Eudamed database includes seven electronic elements including UDI, Vigilance and Market Surveillance. The earlier mandatory use of some Eudamed module would offer an enhanced adoption for this critical element of IVDR deployment.

3. Prior notice if supply of IVD is stopped

To reduce the risk of device shortages, the proposal includes a requirement whereby Manufacturers are required to inform their relevant competent authority and health institutions if there is a temporary, or permanent interruption in the supply of their IVDs, especially if there are few or no alternative products, or where there is a risk of serious harm to patients or public health.

How will this impact industry readiness to IVDR?

The proposal offers a short term solutions for the current state of readiness in the industry for IVDR, especially for Class D devices, which often include low volume, but highly critical diagnostics which were at risk of not meeting IVDR compliance before the deadline of May 2025.

The proposal also encourages an increased usage of Eudamed, which has seen low adoption (caused in part by the delays to each module) by manufacturers within the UDI and Devices module.

In a wider sense, the commission is trying to mitigate the risk of supply shortages as a result of the IVDR transition, although it is currently up to the manufacturer to determine the severity of risk to supply for their products.

Don’t delay

The proposal allows a collective sigh of relief, allowing the industry more time to prepare the technical documentation and engage with a notified body. However in reality, the additional timelines do not offer time to pause. The additional 2 year delay allows the completion of the conformity assessment process, it does not provide any further time for getting the QMS ready for the IVDR. The amendment also allows manufacturers to also ensure their clinical evidence is compliant as we know that legacy devices require additional performance testing before they are IVDR compliant.

In the long term it remains to be seen how significant this amendment will elevate the challenges facing the industry as they transition from IVDD to IVDR. It remains to be seen to what extent the industry will be ready in another 2 years time.

While this should be seen as a positive, we would encourage Manufacturers to press forward with their IVDR transition planning now. For more information on how IVDeology have supported our customers achieve IVDR compliance, contact [email protected].

Note: This blog contains a summary of the key changes within the proposal, it is important that Manufacturers read and understood the proposal in full, and get independent legal advice if required.

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New Regulations Amendments for IVD’s in Northern Ireland

Under the terms of the Windsor Framework, the rules for placing devices on the Northern Ireland market have been different from the rest of Great Britain.  For IVDs, these rules have followed the EU In Vitro Diagnostic Medical Device Regulation (IVDR) 2017/746 since its date of application of 26th May 2022.

A Statutory Instrument (SI) 2024 No. 221 The Medical Devices In Vitro Diagnostic Devices etc. Amendment Regulations 2024 has now came into force as of the 21st March 2024 which enables the IVDR to be fully implemented within Northern Ireland.

This SI sets out the requirements that can be determined according to the IVDR by the competent authority such as fee structures and enforcement provisions.  It also amends other domestic legislation to reflect that IVDR applies in Northern Ireland.

It also:

  • appoints the MHRA as the authority responsible for Notified Bodies,
  • includes the requirements for documentation to be provided in English
  • sets out the requirements for performance studies within Northern Ireland
  • the provision that an IVD testing for SARS-CoV-2 that complies with the EU common specification does not require the separate CTDA approval from the MHRA
  • the requirement for the UK(NI) mark to be affixed if the conformity assessment for CE marking has been completed by a Notified Body established in the UK.
  • The provision for continued unfettered access for Northen Ireland traders to place devices on the GB market with no additional barriers providing the devices meet the requirements of the IVDR and are Qualifying Northern Ireland Goods.

So if you are either a manufacturer that sells into Northern Ireland or based in Northern Ireland, it is worth making sure that you fully understand the requirements set out in the above SI as it is now in effect and how they impact your organisation.

More details can be found at Regulation of devices in Northern Ireland – GOV.UK (www.gov.uk) or you can reach out to us and we’d be happy to have a chat.

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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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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