Tag: #cemark

Posted on by

The MedTech Summit: A reflection

The IVDR journey is a long and difficult path but look how far we have come. Stuart Angell, Managing Director and co-founder of IVDeology attended this years 2024 MedTech Summit in Brussels and shares his thoughts below on the event as it happened.

I was lucky enough to attend the annual MedTech Summit in Brussels this week. I have now attended this event either in-person or virtually since 2019 and the event continues to provide enormous value to regulatory professionals in the medical device and IVD sector.

I was asked to chair the in vitro diagnostic medical device (IVD) track on day 2, including presenting on the regulation of IVDs in the United Kingdom; and I also listened intently to great presentations on the current US (FDA) and European (IVD Regulation (IVDR)) regulatory landscape.  Suffice to say there is a great deal of positive change and complexity; and it was great to get a refresher on the current state of play!

Here are my overall thoughts on the event.

1) The UK remains a key market of interest

Much of my focus this year has been on the regulation of IVDs in the UK, including the utilisation of international recognition, and the domestic under UKCA marking.  I remain a strong advocate of the benefits of UK market access, and the potential for the UK being a world leader in the regulation of IVDs and medical devices. The UK medical device market is worth over €17 billion per annum and potentially offers a route to early adoption of new IVD technology; and it was encouraging to hear the overwhelming support and interest in the UK. The International Recognition is generally considered a positive and progressive step, however, there continues to be uncertainty in the domestic UKCA mark, and its role in global recognition.

2) The US offers a higher degree of certainty; IVDR remains in transition but will come good

This year had much more focus on US Regulation, and with good reason! While the IVDR continues to be implemented, the US is now considered a stable and predictable choice for market access. However, the US 510(k), De Novo and PMA routes should never be seen as an easy route to market. It still requires a great deal of effort to effectively achieve compliance.

For the last few years, l have been highlighting the challenges of IVDR, and the ongoing infrastructural issues that is making the uplift to IVD Regulation from IVD Directive so challenging. While many questions remain, I am taking this opportunity to reflect on the progress that has been made. Ask yourself: “what do I know now about IVDR than I did 12 months ago?” – The chances are quite a lot! So as an industry, we are all heading in the right direction albeit with many miles still to go.

3) We should all encourage and support structured dialogue

One of the challenges with the IVDR is the inability for Notified Bodies to offer advice and consultation.  This has cut off access to technical experts who may have been utilised to provide essential feedback on how to compile and construct technical documentation and performance studies. Developing a structured process for engaging with Notified Bodies, offers a chance for early dialogue on how to successfully achieve compliance. This is especially important for SMEs, or novel devices where the route to compliance is less well understood. Similar models have been employed as part of the US FDA Pre-submission process, and more recently, the UK MHRA IDAP Pilot.

Building this into the IVDR process would allow greater clarity to the industry, making IVDR more understood and ultimately lead to a higher chance of success.

In recent years (and I am guilty of this), we have pointed the finger at what is wrong with IVDR be it lack of guidance from the commission, resources from the Notified Body, or the inactivity of Manufacturers. And yes, some challenges remain, but what I am noticing this year is the desire to bring all stakeholders together to understand areas of weakness and opportunities for improvement which we can all learn from.

One key takeaway for me is the challenges of dealing with the regulatory complexity. This is a challenge for the largest multinationals dealing with a variety of products at different stages of their lifecycle; but also, for SMEs looking to launch one or two products; and considering which markets; and whether to manage the process internally or outsource. Certainly, managing the regulatory process, including post-market surveillance, has become more complex under IVDR; and outsourcing this has got to be a serious consideration; the positive is that these requirements are increasingly aligned across the UK, EU and the USA.

Overall, we all have a part to play in ensuring new innovative products get to market in the UK, Europe and the US; and improving health outcomes. Whilst the recent years have been challenging there is light at the end of the tunnel which should being to offer more certainly and more alignment of regulatory requirements across these jurisdictions which should be a real positive development. So, while the road remains long and challenging, why not take a moment to look back and see how far we have come.

IVDeology’s team has over 30 years’ experience supporting customers on quality assurance and regulatory compliance within the medical device and IVD market.  IVDeology’s services include supporting customers on regulatory filings in a range of territories including EU CE-marking (IVDR), USA (FDA), UK (UKCA) and other jurisdictions, including technical file build, regulatory submissions, regulatory gap analysis, analytical and clinical performance evaluation.

Stuart Angell, Managing Director, IVDeology

We also provide a range of quality assurance services including quality management system (QMS) build, QMS audit and full outsourcing or remote management of QMS systems. We also can be your UK or EU Responsible person.  If you would like to discuss any specific requirements, please contact IVDeology’s highly experienced team or click here.

 

Posted on by

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

Posted on by

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

Posted on by

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