Tag: medtech

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Exploring the EU COMBINE Programme

Understanding and Bridging the Gap in Clinical Research


The European Union’s (EU) healthcare landscape is continuously evolving, driven by the need to integrate
innovative treatments and technologies. One of the most ambitious initiatives in this realm is the EU
COMBINE Programme, launched in June 2023. This programme aims to address the complexities
and challenges at the intersection of three critical regulations: the Clinical Trials Regulation (CTR),
the Medical Devices Regulation (MDR), and the In Vitro Diagnostic Medical Devices Regulation
(IVDR).


Understanding the Need for COMBINE
In the EU, clinical trials of medicinal products, clinical investigations of medical devices, and
performance studies of in vitro diagnostics (IVDs) are governed by distinct regulatory frameworks.
These regulations, while comprehensive, often create operational challenges when combined
studies are required. Combined studies involve:

  • A clinical trial of a medicinal product alongside a performance study of an IVD
  • A clinical trial of a medicinal product alongside a clinical investigation of a medical device

    The COMBINE Programme was initiated to streamline these processes, ensuring that innovative
    treatments combining medicinal products with medical devices or IVDs can be developed more
    efficiently.

    One of the challenges presented by the stakeholders, was the duplication of work by submitting
    combined study application across multiple countries within the EU. Studies spanning multiple
    countries require multiple applications to each competent authority. In some cases, the information
    required, and outcome can vary depending on the country. Not only is this a duplication of work, it
    can put clinical study progression at risk.




The Goals of the COMBINE Programme
The primary objectives of the COMBINE Programme are to:

  1. Analyse Challenges: Identify and understand the root causes of difficulties faced by sponsors
    in conducting combined studies.
  2. Propose Solutions: Develop practical solutions to address these challenges, facilitating
    smoother regulatory processes.

Key Phases of the Programme
The COMBINE Programme is structured into two main phases:

  1. Analysis Phase: This initial phase involved collecting and analysing feedback from various
    stakeholders, including competent authorities, medical research ethics committees, and the
    European Medicines Agency (EMA). The findings were published in an analysis report in May
    2024, highlighting the primary issues and proposing potential solutions.
  2. Implementation Phase: Following the analysis, the Member States endorsed a strategy for
    the second phase in December 2024. This phase focuses on implementing the proposed
    solutions through a series of projects. These projects aim to align the regulatory frameworks
    and simplify the processes for combined studies.

Stakeholder Involvement
The success of the COMBINE Programme hinges on the collaboration of a diverse group of
stakeholders, including:

  • Competent Authorities: National bodies responsible for overseeing clinical trials and
    medical devices.
  • Medical Research Ethics Committees: Groups ensuring that clinical studies meet ethical
    standards.
  • European Medicines Agency (EMA): The agency providing scientific evaluation, supervision,
    and safety monitoring of medicines in the EU.
  • Industry Representatives: Stakeholders from the pharmaceutical and medical device sectors, including associations like the European Federation of Pharmaceutical Industries and Associations (EFPIA) and MedTech Europe.

Progress and Future Directions
As of early 2025, the projects within the COMBINE Programme are progressing according to the
established timelines. Regular reviews and updates ensure that the programme remains on track
and responsive to emerging challenges.


The ultimate goal is to create a more cohesive and efficient regulatory environment that supports
the development of innovative treatments, benefiting patients across the EU

The role of EUDAMED
EUDAMED (European Database on Medical Devices) is an IT system developed by the European
Commission to implement the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical
Devices Regulation (IVDR). With the transition to the new regulations, EUDAMED will be enhanced
to create a more transparent and efficient regulatory tool for all industry stakeholders. However, the
implementation of EUDAMED has seen a number of delays, largely due to the complexity of the
system and resources required to implement. The result has been a lack of coordination between
competent authorities, this can be attributed to some of the challenges identified as part of the
COMBINE programme.

Conclusion
The EU COMBINE Programme represents a significant step forward in harmonizing the regulatory
landscape for combined studies. By addressing the complexities at the intersection of CTR, MDR, and
IVDR, the programme aims to foster innovation and improve patient access to cutting-edge
treatments.

The eventual roll out of EUDAMED will enable greater transparency and communication between
member states, and regulatory authorities.

As the projects within the programme continue to unfold, the healthcare community remains
optimistic about the potential for streamlined processes and enhanced collaboration.

Stay tuned for more updates on the progress and impact of the COMBINE Programme as it continues
to shape the future of clinical research in the EU.

How IVDEOLOGY is supporting the industry
The IVD regulation is a key cog in the mechanism for combined studies. We work with a number of
manufactures developing Companion Diagnostic medical devices, or clinical trial assays which fall
under this regulation. We help build regulatory strategies, and technical documentation to support
regulatory submissions.

Book a call with us to discuss your regulatory challenges or questions and see how IVDeology can
help you

References:

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A review of the MHRA Fee Consultation

Executive Summary

The MHRA (Medicines and Healthcare products Regulatory Agency) held a public consultation on proposed amendments to its statutory fees, to ensure ongoing cost recovery. The consultation ran from August 29, 2024, to October 24, 2024. The majority of respondents (including stakeholders, from UK Approved Bodies, Trade Associations, Manufactures and the public) disagreed with the new medical devices registration fee, hence the MHRA have decided to proceed with the wider fees uplift and continue exploring options for this fee. The implementation date for the proposed changes to the wider fees uplift is early Q1 2025/26.

Introduction

The MHRA regulates medicines, medical devices, and blood components for transfusion in the UK. It operates on a full cost-recovery basis, ensuring financial sustainability and service delivery. Fees are updated regularly to reflect the cost of regulatory activities, including staff costs and corporate overheads. The MHRA, as a department of the UK government, need to be self-sustaining financially. Any activity they perform, and they are critical to the monitoring of medicines, medical devices and IVDs on the UK market, needs to be paid for by cost recovery initiatives, such as those summarised in the consultation document.

Evaluation of Responses

The document evaluates responses to the five proposals:

  1. Proposal 1: Increase statutory fees to ensure continued cost recovery. Most respondents did not agree, citing high costs and impact on SMEs, particularly in the case of the new proposed medical devices registration fee. The MHRA plans to proceed with the wider fees uplift but did refer to existing payment easements for small companies and payment waivers for SMEs for certain fees. However, this does not apply to medical devices or IVDs.
  2. Proposal 2: Amend the Medical Device Registration fee to include post-market work costs. Most respondents disagreed, citing financial burden on businesses, especially SMEs. The MHRA will continue exploring options for this fee and in the meantime, the existing one-off medical devices registration fee will remain but get the indexation increase being applied to all other existing fees (i.e. raising it from £240 to £261).
  3. Proposal 3: Create a new service for regulatory advice meetings for medical devices. Most respondents agreed, but requested more details on scope, format, and timelines. Questions were also raised with regards to the MHRA’s advice versus that of Notified/Approved Bodies, and the risks if advice was contradictory. The MHRA plans to proceed with this proposal.
  4. Proposal 4: Amend fee models for existing services and remove obsolete fees. Most respondents did not have an opinion but agreed in principle and requested more information be provided. The MHRA plans to proceed with this proposal.
  5. Proposal 5: Update the legal definition of a “standard variation” application for homeopathic products. Most respondents did not have an opinion, and the MHRA plans to proceed with this proposal.

Unintended Impacts on Protected Characteristics

The MHRA assessed the proposals for potential unintended discrimination. Most respondents did not have an opinion, but some raised concerns about the impact on product availability for rare conditions and minority groups. The MHRA believes the risk of unintended discrimination is low.

The implementation of this proposal will also see an increase to UK Approved Body fees, which will increase the financial burden on anyone who potentially uses the international recognition route or UKCA marking for classes B, C and D.

The biggest challenge for IVD manufacturers was the proposal to change how fees were applied for device registrations (proposal 2). In the consultation, a change of fees from £240 (one-off fee) to £210 per GMDN code registration (annually) was originally proposed. This would substantially increase the year on year costs of maintaining IVDs on the UK market (often at an increase of up to 5,000%) Whist the increase continued to be considered, the existing one-off medical devices registration fee will remain but get the indexation increase being applied to all other existing fees (i.e. raising it from £240 to £261) will occur later this year (exact date unconfirmed).

Closing thoughts

In summary, we understand that cost have to be recovered for the services the MHRA provide, and in reality, the fees for the UK are lower than many key regulatory markets (e.g. USA). However, in an aid to ensuring the UK continues to have early access to world leading and innovative products, the UK needs to be shaped into an attractive destination for IVD manufacturers in the short term. A substantial increase in medical devices fees, disproportionate to market size, would not support this message.

We will continue to engage with our customers on the outcome from the consultation and potential impacts of this change, as well as continue to engage with BIVDA, our trade association, to work with the MHRA to find a positive way forward.

IVDeology provides expert regulatory consultancy for anyone taking advantage of the UK’s current regulatory pathway, or planning for UKCA transition. We can help you build your regulatory strategy to consider the impact of UK international recognition, and support non-UK manufacturers place product on market utilising our UKRP service.

Book a call with us to discuss your regulatory challenges or questions and see how IVDeology can help you.

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Understanding Companion Diagnostics: A Key to Personalised Medicine

The first companion diagnostic (CDx) was approved by the US Food and Drug Administration (FDA) in 1998 with the European Medicines Agency (EMA) following with approval 2 years later focussed on the cancer treatment drug Herceptin. Since then, the rise of precision medicine has played an increasing part in eliminating the trial-and-error approach to identifying effective treatments for individual patients ensuring that therapies are tailored to their unique biological characteristics.

What Are Companion Diagnostics?

Companion diagnostics are in vitro diagnostic (IVD) tests (or may be an imaging tool), that provide critical information for the safe and effective use of a corresponding drug or biological product. These tests are co-developed with a therapeutic drug and are essential in determining whether a patient will benefit from a specific treatment, be at risk for severe side effects, or require adjustments in their therapy to achieve optimal results.

The labelling of a CDx must include the specific drug it was developed for and likewise the labelling of the drug must indicate the use of the CDx for prescription of the drug.

The US FDA approach to CDx Submission

In the US, the FDA is the central authority and requires that the drug and device are submitted for review and approval at the same time. Thus, the device and drug are developed at the same time and if possible, the device should be used as the Clinical Trial Assay (CTA). The therapeutic drug and it’s proposed CDx need Investigational Drug Application (IND) and Investigational Device Exemption (IDE) submissions and approvals before investigational clinical studies can commence.

During the development process the drug developer will be able to request meetings with the Centre for Drug Evaluation and Research (CDER) and the device developer will be able to meet with the Centre for Devices and Radiological Health (CDRH) via the Q-Submission process. For each of these meetings the respective developer should make it clear that they are co-developing the CDx and it is always useful to request a representative from the other centre to attend for awareness.

In the past the majority of CDx have been submitted and approved via the Pre-Market Approval process (PMA) and are classified as Class III devices. However, in 2024, the FDA announced plans to reclassify many Class IIIs to be Class II and enable manufacturers to submit for market authorisation via the 510K route.

The EU approach to CDx submission

In the EU, CDx are Class C following the classification rule 3(f) under the IVD Regulation 2017/746 and the key difference to the US process is the consultation process between the Notified Body of the device manufacturer and the EMA. The Notified Body will assess the technical documentation of the CDx and when that is complete, they will then consult with EMA for the final assessment alongside the drug file. This secondary process can add around 6 to 8 months to the approval process and needs to be planned carefully to allow sufficient time for market authorisations.

As with the US process, the CDx should be used as the CTA as early as possible, and the clinical use of the assay is often seen as an interventional clinical study requiring complex and lengthy applications to the separate member state competent authorities for approval.

The Future of Companion Diagnostics

Since the first CDx was approved by the FDA in 1998, there are now over 200 cleared or approved listed by the FDA. IVDeology Ltd is seeing the development of companion diagnostics growing alongside advancements in genomics and biotechnology. As our understanding of the genetic and molecular basis of diseases expands, manufacturers have the ability to create more precise and effective diagnostic tests, leading to better patient outcomes and more efficient healthcare systems.

Conclusion

Companion diagnostics are leading the way in the field of personalized medicine. By ensuring that treatments are tailored to the individual needs of patients, these diagnostics not only improve the efficacy and safety of therapies but also pave the way for a more personalized approach to healthcare. As technology continues to evolve, the role of companion diagnostics will undoubtedly become even more integral to modern medicine.

IVDeology Ltd can support small pharmaceutical developers understand the CDx requirements to enable clear and concise discussions with your identified device developers. Likewise we can support CDx developers understand the requirement for consultation with the FDA and the pathway to market approval.

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BIVDA Member IVDeology excited to Sponsor 2025 IVDR Event

IVDeology are excited to announce our first sponsorship of a BIVDA event, the 2025 annual 2-day IVDR Seminar hosted in Birmingham, UK! The event runs the 11th & 12th of February in person.

The ‘British in vitro Diagnostics Association’ (BIVDA) was formed in 1992 and operates from offices in central London. BIVDA is the national association for the IVD industry, including distributors and manufacturers, representing 97% of the market and nearly 250 organisations, with new members joining regularly.

IVDeology have been members of BIVDA for several years, as well as our Co-founder and MD Stuart Angell chairing the Regulatory Affairs working party. BIVDA has been an integral and very important part of IVDeology, allowing the networking and opportunity to collaborate with other IVD professionals, from consultants to Notified Body members, to business owners and others alike.

Being a British IVD consultancy and support team, we knew BIVDA would be the ideal membership for IVDeology, connecting us with specialists in the industry and keeping up to date with legislations and regulations. Membership allows IVDeology access to a board of expert members looking to shape and navigate the regulatory landscape.

And that is a big part of IVDeology and our journey too! Helping our customers navigate the ever-changing regulatory landscape, but helping you learn along the way.

We love being part of a voice for the British diagnostics industry, and our goal is to support those wanting to change and improve lives of patients. So, we are excited to not only be attending the BIVDA Regulatory affairs seminar once again but sponsoring the event too!

What can you expect during the 2 day seminar?

Members will be attend sessions providing detailed and expert opinion and guidance on regulatory topics, with key speakers from the field including:

  • Strategy plan and update for 2025 from BIVDA for it’s members
  • Key note speakers and panel discussions from IVD expert specialists with time for Q&A
  • Recap of 2024 and looking at 2025 activity for the UK IVD industry and what to expect
  • Workshops and break out sessions regarding hot industry topics
  • … and much, more more!

We have several of our IVDeology members attending the event and would be more than happy to chat with you about all things IVD! So please look out for us.

And if you have any questions about becoming a BIVDA member or registering for the event, you can reach out to us at [email protected], or directly to BIVDA at [email protected] or register for tickets at Annual Regulatory Affairs Seminar (2 Day event) Tickets, Tue 11 Feb 2025 at 10:00 | Eventbrite

Or if you’d like to discuss any regulatory compliance support, you can book right in with us via this link to speak to our friendly team

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Key Regulatory Dates for your 2025 diary

The changeable regulatory environment for Medical Devices and In vitro Diagnostic medical devices (IVD) is showing no sign of slowing down as we begin 2025.

The UK Government agency, the Medicines & Healthcare products Regulatory Agency (MHRA) have already provided us with a Roadmap towards the future regulatory framework for medical devices, published on 9 January 2024, recently updated in December 2024.

Given the expectation that these dates are targets, and may change, we can expect the following updates throughout 2025:

January 2025 – Public Consultation on Medical Devices Regulations: Routes to market and in vitro diagnostic devices closes on 05 January 2025.

March 2025 – Publication of new guidance on UK Post-Market Surveillance regulation.

March 2025 – New guidance of use of Exceptional Use Authorisation, including the potential changes in EUA for Covid-19 tests under CTDA.

April 2025 – Potential MHRA Fees change (link to consultation)

April 2025 – Published response on public consultation on UK Post-Market Surveillance regulation.

May 2025 – Certificates issued in accordance with IVD Directive (98/79/EC) Annex VI which shall become void at the latest on 27 May 2025 and can not be used for placing CE marked IVDs on the Great British Market.

June 2025 – Post Market Surveillance Statutory Instrument in force (PMS)

June 2025 – Development of draft guidance on artificial intelligence (AI) development and deployment

Winter 2025 – Statutory Instrument on Pre-Market Requirements

With so much change happening, it has never been so important to engage with your regulatory teams, to understand the impact and implications of the changes and to get ahead of the game. IVDeology work with IVD manufacturers throughout the global industry to Educate, Evaluate and Execute regulatory strategies to Sustain market access.

You can get in touch with IVDeology by booking time with our friendly team here or email i[email protected] – we’d be happy to chat

We also have a series of online webinars that can also support your next steps and understanding of the regulatory landscape, you can check the early 2025 sessions here:

Importance of the role of PRRC (person responsible for regulatory compliance) under MDR and IVDR – 23rd January 2025 The Role of the Person Responsible for Regulatory Compliance (PRRC) Under the MDR and IVDR Training Course

2 day online Introduction to the Invitro Diagnostic Regulation (IVDR) webinar – 5th and 6th February 2025 Introduction to the In-Vitro Diagnostic Regulation (IVDR) Training Course

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UK Labour Budget: Breakdown for Life Sciences Innovative Manufacturing Fund

As part of the first budget prepared by the new UK Labour Government, a new Life Sciences Innovative Manufacturing Fund was announced.

“The government has committed up to £520 million for life sciences manufacturing, to help deliver on the government’s missions to kickstart economic growth and build an NHS fit for the future.

The LSIMF will be UK and sector wide and will provide capital grants for investments in the manufacture of:

  • Human medicines (this includes both the manufacture of active pharmaceutical ingredients (API) / drug substance and finished product / drug product).
  • Medical diagnostics – for both disease identification and monitoring.
  • MedTech products – all types of medical devices related to human health.”

This new initiative could offer an opportunity to grow an SME diagnostic company to enhance their manufacturing capabilities.

“To be eligible for the fund, your project must:

  • Have a total cost (capital and non-capital costs) of at least £8 million
  • Be located in the UK
  • Be primarily a capital investment
  • Be a single company investment (as opposed to forming a partnership between companies or other types of organisations)
  • Require only the amount of grant requested to proceed. For example, without the specific amount of funding you are requesting your project wouldn’t go ahead or go ahead at a smaller scale, go ahead overseas or would be significantly delayed (3 years or more)
  • Be a manufacturing project for the manufacture of:
    • Human medicines (this includes both the manufacture of active pharmaceutical ingredients (API) / drug substance and finished product / drug product).
    • Medical diagnostics – for both disease identification and monitoring
    • MedTech products – all types of medical devices related to human health.

The fund is open to applications for both MHRA-licenced products and products in development where a MHRA licence is intended to be sought for commercial scale-up, for example a manufacturing project for clinical trials.

  • Manufacturing facilities are required to work to Good Manufacturing Practice (GMP) and the facility be intended to support clinical and/or commercial manufacture of API or drug product.
  • Manufacturers of medicinal diagnostics and medical devices must confirm that their device meets or intends to meet the requirements of the Medical Devices Regulations 2002.”

Source: Life Sciences Innovative Manufacturing Fund (LSIMF): application guide – GOV.UK

The reference to the requirement to meet, or plan to meet the Medical Device Regulations 2002. Currently this would require device manufacturers to understand and comply with the current UK regulations, and potentially any new updates relating to UKCA. It would be interested to learn what level of regulatory understanding the manufacturers are required to have and demonstrate as part of the application.

For ideas on building an effective regulatory strategy, find out more in our recent blog: ‘Regulatory Strategy: What is it, and why do I need one?’

You can reach out to us at [email protected] or you can book straight into our diary at a time suitable for you here

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Apply for the MedTech Accelerator: Rapid Regulatory Support Fund 2024

On the 9th October 2024, it was announced that on behalf of the UK Government’s Office for Life Sciences, CPI has created the MedTech Accelerator for companies to apply for up to £30,000 of funding. An exciting opportunity for companies to lean into extra support which is most likely critical for progression of their product compliance journey.

What is the MedTech Accelerator?

It has been developed to help small and medium-sized business to navigate the complex and ever-changing MedTech regulatory landscape and for those who rely on external expertise to develop, commercialise and register life-changing products onto the market, to allow reduction on NHS services and improve patient safety.

This comes after the HealthTech Regulatory Innovation program (HealthTRIP) funded by Innovate UK back in 2022, which similarly help support SMEs overcome regulatory challenges but also hurdles that come along within Quality assurance. The programme awarded 277 companies.

Who is the Accelerator for?

The funding is aimed at UK SMEs developing or offering medical device (including Software as a Medical Device) and diagnostics (including IVD) products or services. Although pharmaceutical products are not considered eligible under this programme, combination medical products such as drug delivery devices would be considered eligible. If you are not sure if your product is eligible, you can reach out to us here at IVDeology to discuss further and we’d be happy to chat.

Am I eligible?

Only UK-based SMEs are eligible to apply to this programme.  

  • Applications will only be accepted from and will be awarded to a single legal entity.  Only one application per company or company group is allowed.   
  • Applications must be from a UK registered SME company which is developing or currently producing and selling MedTech as they are outlined in the Medicines & Medical Devices Act 2021

You can find more information and links here: Eligibility | CPI (uk-cpi.com)

Why should I apply?

The regulatory landscape for MedTech is constantly changing, including a divergence between the UK and EU systems. This is leading to some UK companies finding their products no longer meet the regulatory requirements to be sold within the EU. The MedTech Accelerator: Rapid Regulatory Support fund aims to help SMEs overcome this barrier and hopefully reduce timelines, release financial tension, and encourage businesses to keep moving forward with their innovations and offer some expertise comfort, which is where IVDeology come in.

How do I apply?

Applications opened on Wednesday 9th October 2024, at 9am and close on Thursday 31st October 2024, at midday UK GMT.

CPI will review applications regularly, and if they receive 300 before the deadline, they will close applications early. Companies are, therefore, encouraged to apply as soon as they can as it is a first come first serve.

Please refer to the eligibility section above before proceeding with your application. The form can be downloaded and filled in here: MedTech Accelerator – Rapid Regulatory Support Fund (office.com)

Results Announced: by Friday 29th November 2024 but applications could be stopped earlier dependent on which is reached first, the 300 applicant limit or the date.

You said IVDeology can help – tell me more?

IVDeology have been dedicated to supporting companies of all sizes with their compliance journey since we began in 2018, and regulatory affairs is a HUGE part of that. But we especially understand the strains and challenges SME companies face, starting with design and innovation to regulatory challenges, getting on the market and actually staying there.

We have played a big part in some of our customers funding journey, including a company that applied for the 2022 HealthTRIP innovation grant (as previously mentioned) and used our services to support and perform the following:

  • Regulatory Health Assessment: this allowed us to find any gaps but also strengths within their design and development of the device and highlight areas best to support including being able to put together a regulatory roadmap
    • A gap assessment: this allowed us to review all processes and controls, including technical documentation for Quality assurance as well as regulatory
    • Workshop training sessions: this allowed us to work closely with the team to not only present the work and support, but allow learning opportunities around requirements and what they mean personally to their business
    • Q&A sessions: This allowed focused time with the customer and IVDeology to present any questions, raise any queries and catch up sessions to discuss the outcomes of the workshop sessions
    • Additional support hours: this allowed us to have dedicated time with the customer to work on any additional support that we may have highlighted in the gap assessments, including developing regulatory templates and processes including design and risk management (ISO14971)
    • A draft of a Clinical Evaluation/Performance Evaluation procedure (PER)

IVDeology are here to support you at any stage of your journey. We’re committed to putting time with our customers to understand where you are personally. We can find the gaps and identify the challenges, use our time and your funding wisely with implementing a regulatory strategy from the beginning for clarity, and work with you in a way that supports both your regs needs, but also supporting you with implementing a real working Quality management system (QMS).

We’re happy to work with you in a format that suits you best, from regular supporting hours to training and workshops, and if you’re not sure how best to decide, we’d be more than happy to book in some time to discuss what would work best for you, your team and your business.

We’re excited to see you apply, and we’ll be here to chat with you about supporting this next leg of your compliance journey. You can get in touch with us via LinkedIn, email on [email protected] or simply book time into our calendar here

Written by Casey Sedgwick, IVDeology Customer Success and Marketing Coordinator

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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.