Category: IVD & MDR NEWS

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Role of the UK Responsible Person and the importance for future regulations

Following on from the Statement of Policy intent on international recognition of medical devices released by the MHRA on 21 May 2024, it is clear that the role of the UK Responsible Person will still be important in the future regulations for the UK.  This will be irrespective of whether devices will be placed on the market under the UKCA mark or using one of the recognition pathways from a comparable regulator country (CRC).

A UK Responsible Person (UKRP) is “a person established in the United Kingdom who acts on behalf of a manufacturer established outside the United Kingdom in relation to specified tasks with regard to the manufacturer’s obligations under these regulations.”

There has been a requirement for non-UK medical device & IVD manufacturers to appoint a UKRP in order to place their devices on the Great Britain (England, Wales & Scotland) market since the beginning of 2021. 

A letter of designation must be created and signed by both the manufacturer and the UKRP to officially appoint the UKRP to act on behalf of the manufacturer.  This letter is required to be uploaded as part of the registration process with the MHRA.

The UKRP responsibilities include:

  • ensuring that the declaration of conformity and technical documentation are correct and available if required by the MHRA
  • register the manufacturer, device and any importers with the MHRA
  • liaise with the MHRA for any requests of documentation, samples of devices and with regards to any preventative or corrective actions
  • inform the manufacturer of any complaints or any incidents related to the device
  • terminate the agreement and inform the MHRA if the manufacturer does not comply with the regulations

Selecting your UK Responsible Person should take careful consideration.  It is important that manufacturers appoint someone with the right experience to help with this process.  The manufacturer needs to be confident that the UKRP will be fulfilling their obligations on the manufacturer’s behalf and consequently the UKRP should be considered a critical supplier.  It is important that the manufacturer is assured that if there is a vigilance case identified on the Great Britain market, the UKRP knows how to engage with the MHRA and will communicate the issue in the correct time scales. The manufacturer also needs to be assured that the UKRP can assist with post market reporting and may also deliver regulatory updates which may affect the ability to continue to place devices on the Great Britain market. 

This especially will become more important as the new regulations come into effect.  The government responses to the consultation on the future regulations released in June 2022 indicates that a “Qualified Person” would be required to be permanently and continuously at the disposal of a UKRP.  This “Qualified Person” would need to meet minimum qualifications and/or regulatory experience in the field of medical devices or IVDs. This role is expected to be similar to the Person Responsible for Regulatory Compliance (PRRC) for the IVD Regulation and therefore it will be important for manufacturers to ensure that the selected UKRP can fulfil this requirement.  The UKRP name will also need to be included on the label, although this may be via over-labelling and the MHRA are also investigating the possibilities around digital labelling.

At IVDeology we offer a UK Responsible Person service.  We currently have a number of different customers from across Europe and the US and between them we have registered 489 products with the MHRA to date.

Our onboarding process involves the appropriate contract and letter of designation, followed by a technical review of the devices to be registered by one of our team.  Once confident that everything is in place, the manufacturer and devices are registered with the MHRA.  The process can and has been completed very quickly when a complete technical file has been provided to us for review.

One of the biggest challenges we have faced is around GMDN codes.  The MHRA registration process utilises GMDN codes to register the devices.  Often this has not been considered by manufacturers or the selected codes haven’t been reviewed to ensure that they are still current and appropriate for the device in question.  This can often lead to a delay in being able to register and ultimately placing the device on the UK market.

As a UKRP, we also provide Post Market Surveillance reports for our customers annually and keep them updated with any new relevant information released from the MHRA on future regulations.  This will be more important as the Post Market Surveillance is implemented and also to ensure that our UKRP customers continue to meet the changing regulatory requirements for the UK.

In summary, to place medical devices or IVD’s on the Great Britain market, there is already an established requirement to have a UK Responsible Person.  Whilst currently there are limited restrictions on who this person can be other than they have to be based in the UK and many manufacturers have enlisted their distributor or a UK office to fulfil this role, moving forward it will be more important to ensure that the UKRP that you have selected has the right level of expertise and experience to help support you place your device on the Great Britain market.

You can find out more about our UK Responsible Service here or book a call with one of our team.

Written by Regulatory Specialist Fiona Thompson, IVDeology Ltd and IVDeology UKRP

 

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Laboratory Developed Test regulation – how the US FDA has moved on since 1976


Laboratory Developed Tests (LDT) have been used for decades. However, it is clear that regulatory authorities have seen the misuse of these tests. They are now moving to close the loopholes in regulation that have exploited over the years and the implementation of the European IVD Regulation (2017/746) introduced those controls.

On 29 April 2024, the US FDA published the Final Rule amending the US Food, Drug and Cosmetic Act (FD&C). There are two main purposes for this update:

• To formally identify that IVDs are devices under the FD&C Act, including if they are manufactured in a laboratory but updating the definition of an IVD.
• To phase out the general enforcement discretion approach for LDTs over 4 years. This means that they will now generally fall under the same regulation and enforcement approach as other IVDs.

This update was long overdue, curiously the last time LDTs had been considered was under the Medical Device Amendments of 1976 which amended the FD&C act to ensure the regulation of devices intended for human use. Since then, the FDA has exercised enforcement discretion for LDTs meaning that laboratories designing and manufacturing LDTs did not need to comply with those requirements.

Exceptions to the Rule

The change in rules do not apply to all devices, the following exemptions have been included for some circumstances:

LDTs marketed before Final Rule was published on 06 May 2024

  • Laboratory must still have Medical Device Reporting in place.
  • Must have Establishment and Device Listing in place.
  • Must comply with record keeping requirements.

Tests meeting unmet needs, Nonmolecular antisera LDTs

  • Record keeping requirements must be followed.
  • Other aspects of QMS are expected.

Understanding the Transitional Timelines

The transition will be a graduated process over the next three years. It is important that manufacturers understand what changes are expected, and when they are required.

Conclusion

Bringing LDTs under regulatory control can only be a good thing, the increase in high-risk, high-volume tests being offered to the public e.g. cancer risk prediction under LDT umbrella has forced regulators to act. There is no doubt that the future enforcement of regulatory controls will mean increased costs and resource requirements for those laboratories manufacturing LDTs in the US.

Unlike the EU IVD Regulation, it is clear that the FDA is using a less burdensome approach providing exceptions to the requirement to formally submit applications and wait for approvals if the LDT was already on “on market” before 06 May 2024. This does seem to be their current direction of travel in that they are actively seeking to down classify devices from PMA to 510(K) and to implement ISO 13485 to align Quality Management System requirements going forward.

Control is clearly moving to laboratories offering this type of test having QMS procedures in place to ensure that records are kept, and traceability is maintained. Oversight will be delivered with quality audits identifying issues and Medical Device Reporting highlighting issues to the FDA. The FDA will have the ability to show up on the doorstep of any facility they believe is having issues and this may be identified via market surveillance and/or patient/physician reporting of issues.

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 by clicking here

By Nancy Consterdine, Co-founder and Director of Training at IVDeology Ltd and UKRP

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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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A review of the MHRA International Recognition Statement of Policy

On the 21st May, the Medicine & Healthcare products Regulatory Agency (MHRA) published a Statement of policy  intent for the international recognition of medical devices. The purpose is to describe the overarching policy for recognising other regulatory approvals for medical devices including IVDs. The update to the UK Medical Device Regulations MDR 2002 will be expected in 2025-2026 following the principles described in this policy.

This is the first publication that lays out a rationale and possible process for international recognition, and is a top-level view of the process, where much of the detail will be covered when the Draft Statutory Instrument is published later in the year.

The access routes may not be used for the following device/device types:

  • Exempted in-house devices
  • Custom-made devices
  • Some Software as a Medical Devices
  • Companion Diagnostics relying on equivalence to a predicate, or where associated medicinal substances that are not licenced in the UK

Comparable Regulator Countries (CRCs)

The principle of international recognition is for the utilisation of other regulatory systems. This is typically based on International Medical Device Regulatory Forum (IMDRF) principles.

The initial CRCs described in the policy are:

  • Australia (TGA)
  • Canada (Health Canada)
  • European Union
  • United States of America (FDA)

Proposed Access Routes

Figure 1 Proposed IVD Access Routes

Recognition of CRCs – Class A non-sterile

  • Self-registration with MHRA
  • Declaration to quality management system (ISO13485)

Reliance of European Union (IVDR) – Class A sterile, B, C, D

  • Submission of technical documentation (IMDRF)
  • Post market surveillance plan and report (PMSR or PSUR)

Reliance with Abridged Assessment and Device Specific Requirements of Australia, Canada and United States of America

  • Submission of technical documentation (IMDRF)
  • Post market surveillance plan and report (PMSR or PSUR)
  • Summary of safety and performance (Class C and D)

Basic Requirements

To access the UK market, the devices will be required to meet specific UK requirements, these could include:

Further details on the UK specific requirements are expected to be published in alignment to the IVD roadmap. These will be laid down within the Statutory Instruments which will update the current Medical Devie regulation.

While the information provided is very broad, and much of the detail will be provided in the draft SI documents, the approach taken by the MHRA should be seen as a hugely positive step. The routes proposed provide a pragmatic route, especially if utilising existing CE marking, or 510(k) submissions.

It remains to be seen what the roles and responsibilities for the economic operators in the regulatory chain are, including the UKRP, and the role of UK Approved Bodies. However, I welcome the opportunity to read, understand and reflect on the possible process for International Recognition.

How IVDeology can help?

As a UK based provider of IVD specific quality and regulatory compliance services, we are proud to offer advice and support for the IVD industry on UK market access. This includes:

  • UK Responsible Person (UKRP)
  • UK Compliance readiness assessment
  • QMS review and uplift to UK MDR requirements

For any information on these services, or for any questions on the transition to UKCA, please contact [email protected].

Note: This blog is a personal view of Stuart Angell, Managing Director of IVDeology, based on published documents referenced.

#IVDR #MDR #FDA #510k #IVD #invitrodiagnostics #lateralflow #UKCA

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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]