Tag: regulatory affairs

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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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Navigating the Shift from IVDD to IVDR

Key considerations for lateral flow providers; is it time to outsource your legal manufacturer requirements?

In this regulatory blog Abingdon’s Head of Quality Assurance & Regulatory Affairs Candice Vendetuolli outlines the transition from IVDD to IVDR for lateral flow tests and its implications for manufacturers. One key consideration is whether to use a manufacturing company such as Abingdon Health with an established quality management system operating under IVDR.

Abingdon Health’s team has over 20 years experience in the lateral flow market and is a knowledge leader in the scale-up, transfer, manufacturing and regulatory approval of lateral flow products across a range of sectors including clinical (self-test, point of care), animal health, plant pathogen and environmental testing.

Introduction:

The In Vitro Diagnostic Device Regulation (IVDR) has ushered in a new era for the regulation of diagnostic products, impacting lateral flow tests significantly. As the industry adapts to these changes, outsourcing legal manufacturing to contract service providers with a compliant Quality Management System (QMS) under IVDR is becoming a strategic move for many companies and can remove a major headache.

Transition from IVDD to IVDR

The shift from the In Vitro Diagnostic Directive (IVDD) to the In Vitro Diagnostic Regulation (IVDR) marks a paradigm change in the regulatory landscape. IVDR, implemented in 2017, aims to enhance the safety and performance of in vitro diagnostic devices, including lateral flow tests. Manufacturers must adhere to more stringent requirements, covering clinical evidence, performance evaluation, and post-market surveillance.

The transition to the IVDR has caused significant challenges with infrastructure, Notified Body availability and manufacturing readiness resulting in the European Parliament voting to approve a further extension to the transition period. We took a deep dive in the impact of the extension in our blog last month on IVDR Transition Update which you can take a look at here.

Whilst the extension will be a relief for many, the requirements for manufacturers to prepare are extensive, and this should not be viewed as an opportunity to pause.

Impact on Lateral Flow Tests

Lateral flow tests, widely used for quick and simple diagnostics, face notable changes with the IVDR transition. The regulation demands comprehensive documentation, increased clinical evidence, and heightened scrutiny on post-market surveillance. Manufacturers need to invest in updated technologies and processes to comply with these stringent requirements.

Outsourcing Legal Manufacturing to Contract Service Providers

Amidst these changes, outsourcing legal manufacturing to contract service providers with established and compliant Quality Management Systems operating under IVDR has emerged as a strategic solution.

Providers such as Abingdon Health offer specialized expertise, infrastructure, and a streamlined process to navigate the complexities of the new regulatory framework. Abingdon Health’s Quality Management System operates under IVDR and therefore the addition of new products is a relatively straightforward process and can provide a more rapid and cost-effective transition to IVDR for lateral flow products.

Instead of having to replace your current IVDD compliant QMS with one that meets IVDR; or having to create a QMS of IVDR from scratch; you can tap into Abingdon’s existing QMS. Furthermore, given the requirements under IVDR are more onerous (e.g. post market-surveillance); outsourcing these activities to an experienced provider may make more sense; and be more cost-effective. Finally, if you are a company with one or a small number of products, it is very inefficient to run a QMS purely for this; with the fixed costs of running a QMS being significant.

Why Outsource Manufacturing under IVDR

  1. Expertise and Experience:

Contract service providers bring a wealth of experience and expertise in navigating the intricacies of IVDR. Their teams are well-versed in the regulatory landscape, ensuring compliance and reducing the risk of errors. Abingdon’s team has experience of working with notified bodies and managing the regulatory process on your behalf.

  1. Efficiency and Speed:

Outsourcing manufacturing to a specialized provider accelerates the production process. These providers are equipped with advanced technologies and efficient workflows, enabling quicker turnaround times for lateral flow tests. Abingdon’s Quality Management System is already established under IVDR; and therefore, it’s much quicker to use Abingdon rather than establish a brand-new quality management system for one product for example.

  1. Cost-Effectiveness:

Leveraging a contract service provider can be cost-effective compared to establishing in-house capabilities compliant with IVDR. Companies can allocate resources more efficiently, focusing on core competencies while relying on the expertise of external partners such as Abingdon.

  1. Risk Mitigation:

With IVDR introducing stricter regulatory requirements, outsourcing to a reputable service provider mitigates risks associated with compliance. These providers invest in continuous training and updates to ensure adherence to the latest regulations. For example, the post-market surveillance obligations under IVDR are significant and Abingdon Health has these processes established. This gives Abingdon’s customer peace of mind that these ongoing obligations are being dealt with.

  1. Flexibility and Scalability:

Contract manufacturing offers flexibility and scalability, crucial in the dynamic landscape of diagnostic devices. Companies can adjust production volumes based on market demands without the constraints of maintaining fixed in-house capacities.

  1. Access to Advanced Technologies:

Contract service providers often invest in cutting-edge technologies and state-of-the-art facilities. Outsourcing allows companies to benefit from these advancements without the upfront costs associated with acquiring and maintaining such resources.

  1. Regulatory Intelligence

The Abingdon Health group are ideally placed within the IVD industry to scan the horizon to monitor and adapt to updates ad changes to the European regulatory landscape, to ensure that our regulatory and quality system are state of the art and compliant to international standards.

Examples of IVDR transition and why outsourcing makes sense.

One example of why IVDR transition makes sense is for growth companies developing a new lateral flow test. Tapping into Abingdon Health’s established Quality Management System will save significant time and money and speed up the time to market and revenues.

A second example is an established diagnostics company selling a range of products that are CE-marked under IVDD. The Quality Management System is set up to manage all products and therefore if certain products are being prioritised for transition under IVDR, for example if they are Class D (high risk) tests then it may make sense to outsource the transition of these products to a contract service provider such as Abingdon Health. This keeps the process separate and “clean” and also means that you can leverage off Abingdon’s established Quality Management System.

Post Market-Surveillance

Post-Market Surveillance (PMS) is worth setting out in more detail. It is a critical change to the approach under IVDR and requires a lot more consideration, and resource. Abingdon Health has established processes to manage this process effectively on behalf of its customers.

The key requirements of post-market surveillance for Class A and B products are to summarise the results and conclusions of the analyses of the post market surveillance gathered, together with a rationale and description of any preventative and corrective actions taken.

In addition, for Class C and D devices other requirements include the conclusion of the benefit-risk determination, the main findings of the PMPF and the volume of sales and estimate of the size and demographics of the users. This information needs to be updated per product annually.

The PMS documentation requirements are significant: PMS System (all products), PMS Plan (all products), PMS Report (Class A and B products), PSUR reports (Class C and D products), SSP reports (Class C and D products) and if required for any class of products: Vigilance Reports, Trend Reports and FSCA reports. It is critical that this information is kept up to date as this information can be reviewed during your annual audits or unannounced audits and also will be reviewed at least once every 5 years as part as product re-certification.

Key Takeaways

The transition from IVDD to IVDR brings both challenges and opportunities for manufacturers of lateral flow tests. Outsourcing legal manufacturing to contract service providers operating under IVDR offers a strategic avenue for companies to adapt to the evolving regulatory landscape efficiently. By tapping into external expertise, leveraging advanced technologies, and ensuring compliance, businesses can navigate the complexities of IVDR while maintaining a focus on innovation and market competitiveness.

Decades of experience in taking tests from concept to commercialisation has led to Abingdon Health establishing effective processes to minimise risk and maximise the chances of commercial success. Abingdon’s regulatory team has experience on managing the IVDR transition process and ongoing obligations and can support your inhouse team or provide a fully outsourced regulatory solution to ensure you are well-prepared for your IVDR transition.

If you would like to understand more about the regulatory process, including FDA, CE-marking and UKCA-marking and discuss any specific requirements or concerns, contact a member of the IVDeology team by clicking here

Or if you’d prefer an easy and on-the-go accessible app right on your handheld device such as phone or tablet, you can download our IVDeology app which has the current IVDR specification handbook and for quick access to support from IVDeology – available for Android and Apple Store FREE download

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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.