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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:

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.