Tag: MDR

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US IVD Classification – How different can it be?

IVDeology have decades of IVD (invitro diagnostics) compliance support experience within the Quality and regulatory industry, with backgrounds from microbiology to lab based experience, and recently becoming part of the Abingdon Health PLC to offer a more holistic range of services from cradle to grave of diagnostic products. Co-founder and Director of training Nancy Consterdine talks about the US classifications of devices, having worked recently with US 510K submissions including pre-submissions.

The Global Harmonisation Task Force (GHTF) published their classification guidance in June 2006 proposing a risk based, 4 tier classification system for In Vitro Diagnostic Devices. This guidance has been widely used since 2006 for new regulatory systems being set up around the world e.g. the IVD Regulation in Europe 2017/746.

However, the United States of America (US) had already introduced a 3-tier risk-based classification system back in 1976 with the amendments to the Food, Drug and Cosmetics act (FD&C) to include medical devices. This system has now been in place for 48 years, despite amendments having been made around the regulatory pathways e.g. introduction of the 510K De Novo program, enacting of the Small Business Determination program and electronic submission processes. So, how does the classification system work currently and what are the future changes that the FDA are proposing?

Figure above shows class |, || and ||| and risk (explained below)

Class 1

  • Low to Moderate Risk devices e.g. Transport culture medium, immunoelectrophoretic equipment, Biological stains
  • Subject to General Controls (Regulatory Requirements which apply to all medical devices) all covered under a quality management system:

    – Registration of producers of medical devices.
    – Notifications and other remedies e.g. recall.
    – Records and reports on devices e.g. adverse event report.
  • Manufacturers are still visible to FDA and may be subject to audit.
  • Devices may be exempted from a General Control as stated in the classification regulation for that device e.g. they may be exempt from GMP other than keeping records and complaint files.
  • Devices are submitted via the 510K pre-market notification process but some are exempt.

Class II

  • Moderate to High Risk e.g. Blood Culture Assay, Rubella ELISA Test
  • Subject to General Controls and Special Controls:
    – Device specific
    – Evidence of meeting performance standards
    – Post market surveillance
    – Adherence to guidelines
    – Special labelling requirement
  • General Controls are considered insufficient to provide assurance of safety and effectiveness.
  • Devices are submitted for pre-market notification via 510K process.

Class III

  • High Risk e.g. Cancer Biomarker companion diagnostic assay
  • Subject to General Controls and Premarket Approval:
    – Quality Management processes and controls
    – Software design, development and cyber security
    – Analytical Verification data
    – Clinical Performance Data
  • Pre-Market Approval (PMA) application is required

Recent Developments

In January 2024, a press release from Jeff Shuren, the director of the Centre for Devices and Radiological Health (CDRH) announced the intent to initiate the reclassification process for most IVDs which are currently class III (high risk) into class II (moderate risk). They identified that the majority of these tests are infectious disease and companion diagnostic IVDs. This is in line with the FDA least burdensome approach allowing manufacturers of some devices to seek marketing clearance through the 510K premarket notification route. In the release it also talked to the FDA desire to encourage more manufacturers to develop the test and in turn increase competition and access to these important tests.

The process of reclassification has already started with a panel meeting in September 2023 identifying 3 types of infectious disease diagnostic IVDs

  • Nucleic acid and serology based IVDs to aid diagnosis of Hepatitis B Virus infection and management of infected patients.
  • Serology based IVDs for detection of human parvovirus B19.
  • Cell mediated immune reactivity IVDs to aid identification of in vitro responses to peptide antigens associated with TB infection.

Conclusion

The IVD industry can only welcome these moves by the FDA in conjunction with the amendment of the Quality Management System regulation (QMS) to be more closely aligned to the ISO 13485:2016 standard. It makes the USA a far more inviting prospect for initial market authorisation applications. The costs are transparent, the timelines are clearly identified and there is a process in place to present and discuss the device with the FDA in a pre-submission meeting.

There are however other considerations that need to be taken, Jeff Shuren has recently announced his retirement and Dr Michelle Tarver will assume the role of CDRH Acting Director. Also, there are presidential elections this year, will these changes impact the current trajectory of the CHRH? We at IVDeology will continue to monitor the situation across the pond, it is evident that since Brexit the UK government has been eager to foster recognition of other regulatory body approvals and it does feel that the movement of the FDA approval process is going in the same direction as that of the UK MDR.

Next steps to consider, and how we can help.

IVDeology Ltd can support with all of the above, please contact us for a friendly conversation to identify how we can support you with your compliance journey via our contact page

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MDSAP: Explaining the complexities and importance

The Medical Device Single Audit Programme (MDSAP) is a system by which the participant competent authorities to recognise the quality management certification (as awarded after audit against both ISO 13485 and county specific requirements) from a single authority for medical device and in-vitro diagnostic medical device (IVDs) legal manufacturers.

The programme has been established by the International Medical Device Regulators Forum (IMDRF) and is intended to provide a harmonised approach to demonstrating the compliance of the Quality Management System (QMS) using a globally recognised approach.

The MDSAP was developed by the IMDRF to:

  • Enable appropriate regulatory oversight of medical device manufacturers’ quality management systems while minimizing regulatory burden on industry;
  • Promote more efficient and flexible use of regulatory resources through work sharing and mutual acceptance among regulators while respecting the sovereignty of each authority;
  • Promote globally, in the longer term, a greater alignment of regulatory approaches and technical requirements based on international standards and best practices;
  • Promote consistency, predictability and transparency of regulatory programs by standardizing;

    1. the practices and procedures of participating regulators for the oversight of third party auditing organizations, and
    2. the practices and procedures of participating third party auditing organizations

Regulatory Authorities

MDSAP consists of Regulatory Authority Council Members, Observers and Affiliate members:

Regulatory Authority Council Members:

  • Therapeutic Goods Administration of Australia
  • Brazil’s Agência Nacional de Vigilância Sanitária
  • Health Canada
  • Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency
  • U.S. Food and Drug Administration

The RAC is the decision-making body of MDSAP and consists of representatives from all regulatory authorities that are members of the RAC. The RAC provides direction, oversight, and resources to support the MDSAP development, implementation, maintenance, and expansion.

Observer Members:

  • European Union (EU)
  • Singapore’s Health Sciences Authority (HSA) (NEW)
  • United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA)
  • The World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Programme

The observers do not observe RAC members and do not attend RAC meetings, but they do observe and contribute the RAC activities. Both the EU and UK have been Observers for over 2 years, and as such, can apply to become full RAC members if desired.

Affiliate Members:

  • Argentina’s National Administration of Drugs, Foods and Medical Devices (ANMAT)
  • Ministry of Health of Israel
  • Kenya’s Pharmacy and Poisons Board (New member)
  • Republic of Korea’s Ministry of Food and Drug Safety
  • Federal Commission for Protection from Sanitary Risks (COFEPRIS) of Mexico
  • TFDA – Taiwan Food and Drug Administration

Affiliate members are not members of the RAC or an Official Observer, but engages in MDSAP, demonstrates understanding of MDSAP and utilizes MDSAP audit reports and MDSAP certificates for evaluating compliance with applicable medical device requirements, including a manufacturer’s quality management system, under the Affiliate Member’s regulatory framework.

The application of the MDSAP Programme

The utilisation of the MDSAP programme, and the resulting certificates are utilised differently depending on each Competent Authority as dedicated by each regional requirement.

Regulatory AuthorityUtilisation of MDSAP
AustraliaMDSAP audit report is used as part of the evidence that it has assessed for compliance with medical device market authorization requirements, unless excluded or exempt from these requirements.
BrazilANVISA utilizes the outcomes of the program as part of the pre-market and post market assessment.  
CanadaManufacturers intending to place a product on the market in Canada must have an MDSAP Certification issued by an Auditing Organization.
JapanThe Ministry of Health, Labour and Welfare (MHLW) and Pharmaceutical and Medical Devices Agency (PMDA) utilize these audit reports in pre-market and post-market audits.
United StatesU.S. FDA will accept the MDSAP audit reports as a substitute for FDA routine inspections under a 510(k) device application. The use of MDSAP is not utilised for pre-approval or post-approval inspections for Pre-Market Approval (PMA) applications.

The regulations for the above Regulatory Authorities are available (English) from the USA FDA Website.

The use of the MDSAP programme and certification will be greater utilised as he programme expands and more regulatory authorities recognise the value in this process.

The MDSAP Audit Cycle and Auditing Organisations

Auditing Organisation are certification bodies that have successfully applied, and been recognised by the MDSAP programme to audit medical device manufacturers against the requirements of the MDSAP programme. The current list includes many European Notified Bodies (under EU IVDR), and UK Approved Bodies (under UKCA) and are globally recognised.

The MDSAP audit is typically build on to the existing ISO 13485 certification audit of the Quality Management System with a 3-year audit cycle.

Figure 1 MDSAP Certification Cycle

Will MDSAP come to the EU and UK?

There is much talk regarding the use of MDSAP by the EU and UK. While I am a strong advocate in global harmonisation, the existing members joined MDSAP to find a harmonised way to create a robust process for standardising QMS requirements from a position where they needed to find a suitable and robust process. Regardless of the state of play in the EU and UK, both regions already have robust mechanisms for the surveillance of ISO 13485, largely provided by the technical and commercial expertise of EU and UK Notified Bodies and Approved Bodies (as part of ISO13485 certification/IVDR conformity assessment), so the utilising MDSAP would be less impactful.

The opportunity would be regarding the outward facing regulatory convergence of EU and UK to align, and reduce burden for accessing other markets, MDSAP would be a good way of doing this. We have seen TGA become well placed in MDSAP/IMDRF mainly utilising CE marking for supporting AUS market access.

The challenge with MDSAP is that each jurisdiction has specific requirements, which make the MDSAP process clunky. The key to an improved model is to remove local requirements as much as possible, however this is dependent on global alignment at a political as well as regulatory level.

References

If you’d like to discuss MDSAP with us, you can book a call with the IVDeology team as we navigate this new programme and what it means for you as a manufacturer or provider of IVD’s and devices with each of the individual requirements. Being part of BIVDA (British In Vitro Diagnostics association), we’re in a great position to be able to receive and understand information and distribute to our networks as it comes, in a reliable and digestible way.

Or if you’d like support in other areas of Quality assurance or regulatory compliance, we’d be happy to chat with you. We can support with Quality management system implementation, transfer or uplifting.

We’ll be keeping you up to date with MDSAP news on our LinkedIn page and website, so do follow up on our socials and keep up to date with IVDeology along with Abingdon Health PLC.

Written by Stuart Angell, MD and Co-founder of IVDeology and IVDeology UKRP

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A QMS isn’t just for IVDR conformity assessment…. it’s for life!

In this blog we are going to discuss our views on the benefits and need to have and maintain your Quality Management System (also known as a ‘QMS’)

IVDeology have decades of experience supporting IVD companies and manufacturers all across the globe with their Compliance journey within Quality and regulatory, and Jo Angell, our Quality and operations coordinator at IVDeology talks about the importance of a QMS that can grow with you, having experienced managing IVDeology’s own Quality management system internally at IVDeology as well as setting up and hosting other companies QMS.

What is a QMS?

  • Quality is defined as the “degree to which a set of inherent characteristics of an object fulfils requirements” [ISO 9000:2015, 3.6.2]
  • A management system is a set of interrelated or interacting elements of an organization to establish policies and objectives, and processes to achieve those objectives. [ISO 9000:2015, 3.5.3]

The 2 main standards covering QMS for Medical Device (including In Vitro Diagnostic (IVD)) manufacturers are:

For medical laboratories, where IVDs are used or developed as a Lab Developed Test (LDT) the additional ISO 15189:2022 Medical laboratories — Requirements for quality and competence, can be utilised.

Why have one?

It is true that establishing and maintaining a Quality Management System requires additional investment, both financially and from a resource perspective, there are substantial benefits for having one:

  • Demonstrates to customers your commitment to quality
  • Standardisation of processes
  • Consistent training throughout the organisation
  • Ensures continuous improvement
  • Improved productivity and efficiency
  • Reduced waste steps
  • Improved customer satisfaction
  • Ensures controls are in place to make safe and effective products
  • Identification and control of risks
  • Control and assessment of suppliers

An effective QMS can provide a solid foundation of quality and safety in a consistent and well-organised ecosystem

You will need one if you are intended to place IVDs on market

For the EU the IVDR states that: “all manufacturers should have a quality management system and a post market surveillance system in place which should be proportionate to the risk class and type of device in question”

As a legal manufacturer of an IVD or medical device a QMS must be implemented and compliant to the applicable regulations where you place your device on market. For EU CE marking under the new IVDR transitional timelines,  this shall be no later than 25th May 2025. This is less than 12 months away!

Who’s responsible for maintaining the QMS?

Typically, this is the role of the Quality contact in any organisation. However, establishing a quality culture, and ensuring the QMS has been built, and maintained effectively is the role of the organisations top management. They need to demonstrate leadership and a commitment to the QMS.

Maintaining your QMS

A good and efficient QMS supports your company with the best way to do things, by having input from across the organisation these processes can be agreed on and will be committed by everyone in your organisation. An effective QMS should be everyone’s objective, not just Quality!

A QMS should grow as your organisation grows

A QMS is not a one size fits all, it needs to build and grow with your organisation and will never be a finished article, it should always be continually improving. The complexity and scope should also reflect the nature and size of your organisation.

eQMS are great but…

Electronic QMS software provide a great tool, but you need to build the QMS with you in mind. These will never be an off the shelf ready to go package. All templates will need to be customised and adapted to fit your organisation and processes, otherwise the QMS just won’t work.

You have the certificate and placed the product on market – but what next?

In a previous blog, we discuss the challenge of Post Market Surveillance, and what is expected , mainly from a UK point of view:

“The manufacturer shall institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase and to implement appropriate means to apply any necessary corrective actions, taking account of the nature and risks in relation to the product.”

This means that as manufacturers you still need to be collecting data on how effective your device is – monitoring your customer complaints and feedback, any incident reporting, your manufacturing information, looking at your trends, to mention just a few possible sources of information. This data should then be reviewed to determine whether any updates are required and if so, these actions should be documented appropriately. Potential updates could impact your:

  • Risk Management File – Is the Severity of the risks impacted? Does it impact your frequency of occurrence of known risks? Are there new risks that you haven’t included?
  • Instructions for Use & Labelling – Do you need to add additional warnings? Are your instructions clear enough?
  • Training – Is any training that you provide sufficient? Is additional training necessary for your users?
  • Other products – Does the issue impact other devices you manufacture

5 Top Tips from the team on how to effectively build and maintain a QMS

  1. Get buy in from senior management – if they don’t understand what a QMS is, and why it is important (and not just required), it will never be supported and managed effectively.
  2. It is a growing, living thing, the more you feed it, the stronger and more robust it will be. It needs love and attention to get the most out of it.
  3. QMS software will save you time and money in the long run.
  4. Most non-conformances are raised against your own processes, not the standard. Make your procedures as simple and as clear as possible, ensure the people doing the work are involved in creating the processes, they know their processes the best!
  5. Use internal audits to strengthen and improve your QMS and use your business risk assessments as a tool to help the business overcome challenges and move on new opportunities

If you’ve got this far, you’ll hopefully understand the importance of a fully functioning and certified QMS but may be worried about where to start. At IVDeology (an Abingdon Health company) we offer full service solutions for QMS amongst our nose-to-tail regulatory support services. We can support you by:

  1. Being Legal Manufacturer (all QMS responsibility lies with us)
  2. Build your QMS for you
  3. Host your QMS within our ISO certified system or we can put you in touch with Cognidox, a QMS system we use at IVDeology ourselves

Our team of experts have a proven track record for the development and maintenance of Quality Management System ranging from SME to large IVD manufacturers. To hear more about how we can support, please contact [email protected] or click ‘get in touch’ to book in with our customer success coordinator

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EUDAMED: A recap for what it means for you

IVDeology are a UK based regulatory and quality compliance support company, with over 100 years combined of expertise within our team, providing you everything you need for your in-vitro diagnostic device life cycle to support you on your compliance journey. In this most recent blog written by Regulatory specialist TszWai Woo takes a look at what EUDAMED is, and what the changes mean to you.

The Medical Devices Regulation (Regulation (EU) 2017/745, ‘MDR’) and the In Vitro Diagnostic Medical Devices Regulation (Regulation (EU) 2017/746, ‘IVDR’) introduced the requirement of EUDAMED, the European database on medical devices. It has been over 3 and 2 years, respectively, since the date of application of the MDR and IVDR, and even after several transition extensions and amendments to both regulations, EUDAMED is still a way off from being fully functional.

With another proposed Regulation (2024/0021 (COD)) due to be published in the Official Journal of the European Union, it is worth having a recap on what EUDAMED is, the current status and what changes the new regulation will introduce.

What is EUDAMED?

EUDAMED is a European database on medical devices that the European Commission was to set up, maintain and manage, as required by the MDR and IVDR. The aim of EUDAMED is to improve transparency and provide information on medical devices on the EU market to the public and healthcare professionals. It also aims to improve medical device traceability, enhance coordination between the EU National Competent Authorities and provide them with easy access to relevant regulatory information.

EUDAMED contains information on medical devices which are organised into the following 6 categories, also known as modules:

  • Actor registration
  • UDI/Devices registration
  • Notified Bodies and Certificates (except for the mechanism for scrutiny and the clinical evaluation consultation procedure (CECP) functionalities)
  • Clinical Investigations and Performance Studies
  • Vigilance and post-market surveillance
  • Market Surveillance

A lot of the information within EUDAMED is to be accessible to the public via a public website.

Current State of Play

To date, only the following 3 modules have been available for voluntary use:

  • Actor registration (since December 2020)
  • UDI/Devices registration (since Oct 2021)
  • Notified Bodies and Certificates (since Oct 2021)

Therefore, manufacturers can submit their organisation and device details on a voluntary basis.

For Actor registration, as well as providing the organisation details, all manufacturers will need to provide a declaration on information security responsibilities and non-EU manufacturers will also need to provide a mandate summary document.

For UDI/Device registration, manufacturer will need to submit device information such as the Basic UDI-DI & UDI-DI, the European Medical Device Nomenclature (EMDN) and notified body (NB) certificate information (if applicable). For devices requiring NB conformity assessment, the NB must confirm the device information in EUDAMED before the device can be publicly available. Therefore, conformity assessment must be completed before prior to registering a device in EUDAMED.

NBs can register certificates and Summaries of Safety and Clinical Performance (SSCP) on voluntary basis. However, there is a caveat: all the parties referenced in the certificates must first be registered, also on a voluntary basis, in EUDAMED.

Additionally, the ‘Vigilance and post-market surveillance’ and ‘Market Surveillance’ modules are due to be made available Q2/2024 and the ‘Clinical Investigations and Performance Studies’ module is not due to be made available before Q3/2026.

EUDAMED was intended to be mandatory for all economic operators to use, after all 6 modules were declared fully functional following an independent audit and a Commission notice was published in the Official Journal of the European Union.

Proposed changes to EUDAMED requirements

Instead of waiting for the completion of the 6th module to make the use of EUDAMED mandatory, 2024/0021 (COD) proposes a gradual roll-out of the mandatory use of each EUDAMED module, once they have been audited and declared functional.

This means that the mandatory use of 3 modules (Actor registration, UDI/Device registration and Notified Bodies & certificates) could therefore start in Q4/2025.

Given the requirements of Article 123 (3) (d) MDR/113 (3) (f) IVDR and Article 123 (3) (e) MDR/113 (3) (a) IVDR, this would mean that mandatory use of all six modules cannot be expected before Q4/2027 and final transitional periods will not end before Q2/2029.

Final Thoughts

Whilst the medical device industry waits with bated breath for the proposed regulation to be published in the Official Journal of the European Union, it is advisable that manufacturers ensure they understand and have all the information they need for the EUDAMED Actor and UDI/Devices registration processes. Hopefully, the proposal will encourage more manufacturers to register on a voluntary basis, as delays in the module development have resulted in low adoption of EUDAMED.

As a UK provider of quality and regulatory services, IVDeology are proud to engage with the IVD industry and keen to support IVD manufacturers with IVD devices market access. For further information on how we can help, please contact [email protected] or you can book straight into our calendar here

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

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Consultation on UK Common Specifications

On the 21st May 2024, the Medicines & Healthcare products Regulatory Agency (MHRA) launched a consultation on common specification requirements for invitro diagnostic devices. The aim of this consultation is to gauge industry opinion over a 4 week period on introducing common specifications requirements for certain high risk IVD devices placed on the Great Britain (GB) market.

What are common specifications?

Common specifications (CS) set out a minimum set of performance requirements for specific high risk IVDs, principally to ensure a higher level of patient safety. These common specifications will replace the existing ‘Common Technical Specifications’ described under the current Medical Device Regulations (UK MDR 2002).

The consultation asks the following questions:

  • Should GB common specifications align with the European equivalent, as set out under (EU) 2022/1107
  • Should monitoring for common specifications be included within a Post Market Performance Follow-up Plan (a key document to describe post market performance data collection)?
  • Should Covid-19 IVD devices meet a common specification rather than meet the existing CTDA requirements?

The consultation is an opportunity for industry to offer a view on how aligned GB common specifications should be to the EU. In addition, feedback can be given for the potential removal of the much-discussed CTDA process, which could mean that Covid-19 IVD devices will undergo the general process for conformity assessment via UK approved bodies.

You can submit your views and include comments on the consultation here. The consultation is due to end on the 18th June, so I would encourage any interested parties to submit their views – this is an opportunity to shape the way CS are used in GB.

As a UK provider of quality and regulatory services, IVDeology are proud to engage with the IVD diagnostic keen to support IVD manufacturers on IVD market access. For further information on how we can help, please contact [email protected]

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

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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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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.