Tag: regulatory affairs

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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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What Are EU Reference Labs for IVDs?

EU Reference Labs for IVD’s – explained

In vitro diagnostic medical devices (IVDs) play a vital role in providing essential information for the diagnosis, monitoring, and treatment of diseases.  IVDs must comply with the In Vitro Diagnostic Medical Device Regulation (IVDR – Regulation (EU) 2017/746) to be placed on the European Union (EU) market.

The IVDR introduced the concept of EU Reference Laboratories (EURLs) for IVDs. EURLs are specialised laboratories designated by the European Commission, to provide scientific and technical expertise for specific types of high-risk IVDs. The designation and responsibilities of EURLs are outlined in Article 100 of the IVDR and more details are laid out in Commission Implementing Regulation (EU) 2022/944.

Designation & Responsibilities of EURLs

For a laboratory to be designated as an EURL by the European Commission, it must:

  • Demonstrate appropriate expertise and experience in the relevant field
  • Have adequate staff with appropriate qualifications
  • Possess necessary equipment and reference materials
  • Show impartiality and independence from commercial interests
  • Comply with ISO/IEC 17025 and other relevant standards
  • Have appropriate quality management systems in place

Once designated, EURLs’ tasks include the following:

  • Performance Verification – EURLs verify the performance claims of class D IVDs by conducting laboratory tests on samples provided by manufacturers i.e., EURLs carry out tests on each manufactured batch of devices.
  • Common Specifications Development – EURLs contribute to the development of common specifications and technical guidance for specific types of devices.
  • Technical Assistance – EURLs provide scientific advice and technical assistance to national authorities, notified bodies and manufacturers.
  • Reference Materials Management – EURLs establish, manage, and make available reference materials and methods for high-risk IVDs.
  • Coordination Role – EURLs coordinate a network of national reference laboratories to harmonize testing methodologies and practices across the EU.
  • Research and Innovation – EURLs contribute to research and innovation in their specific areas of expertise.

Types of IVDs Subject to EURL Assessment

The EURLs verify the performance claims and carry out batch testing on high-risk (Class D) IVDs:

  • Devices which detect the presence of / exposure to, a transmissible agent in blood / blood components / cells tissues / organs / any of their derivatives, to assess their suitability for transfusion / transplantation / cell administration.
  • Devices which detect the presence of / exposure to, a transmissible agent that causes a life-threatening disease with high propagation risk.
  • Devices which determine the infectious load of a life-threatening disease, where monitoring is critical in the process of patient management.
  • Devices for blood grouping, which determine any of the following markers:
    • ABO system [A (ABO1), B (ABO2), AB (ABO3)]
    • Rhesus system [RH1 (D), RHW1, RH2 (C), RH3 (E), RH4 (c), RH5 (e)]
    • Kell system [KEL1 (K)]
    • Kidd system [JK1 (Jka), JK2 (Jkb)]
    • Duffy system [FY1 (Fya), FY2 (Fyb)]

Impact on the Industry

EURLs for IVDs have an impact on both IVD manufacturers and notified bodies.

Manufacturers of class D IVDs must submit samples of their device to an appropriately designated EURL for the EURL to verify performance claims and compliance to any common specifications. Manufacturers must then incorporate any feedback into their technical documentation. Prior to release of a batch of any Class D IVDs, manufacturers must wait for EURLs to confirm they have completed their tests.

Notified bodies will need to consult with EURLs when assessing certain high-risk IVDs and factor in EURL’s opinions into their assessment decisions. Notified bodies will also have to maintain communication with EURLs for post-market surveillance.

Implementation Challenges

Although the IVDR became fully applicable on 26 May 2022, implementation of the regulation has not necessarily been smooth. The timelines to which certain devices must be compliant to the IVDR have been extended more than once and establishing a EURL network has been challenging. Resources have been restrained, as building the necessary infrastructure and hiring the appropriate expertise has required significant investment and coordination.

As a result, the European Commission adopted a phased approach to EURL designation and until EURLs are fully operational for all relevant device categories, interim procedures have been established for the conformity assessment of class D IVDs. MDCG 2021-4 provides guidance on how EURLs should be integrated into the conformity assessment process when designated.

Current State of Play

The European Commission have designated the following 5 EURLs by the implementing act Commission Implementing Regulation (EU) 2023/2713

Designated EU reference laboratoryScope of designation Class D devices intended for detection or quantification of markers of:
Consortium managed by Servicio Madrileño de Salud (SERMAS), Spain and composed of: Hospital General Universitario Gregorio Marañón, Spain Hospital Universitario la Paz, Spain Hospital Universitario Ramón y Cajal, SpainHerpesvirus infection Infection with bacterial agents
Consulting Químico Sanitario SLU (CQS), SpainHerpesvirus infection Infection with bacterial agents
EU Referenzlabor für In-vitro-Diagnostika am Paul-Ehrlich-Institut (PEI-IVD), Germany Hepatitis or retrovirus infection Respiratory virus infection
Instituto de Salud Carlos III (ISCIII), SpainHepatitis or retrovirus infection Herpesvirus infection  Infection with bacterial agents
RISE Research Institutes of Sweden AB (RISE), SwedenRespiratory virus infection

These EURLs took up their tasks in the conformity assessment of devices on 1 October 2024.

In February 2025, the European Commission launched a further call for more applications to be submitted by Member States on behalf of their candidate laboratories for designation of EURLs. This call will be conducted in 2 waves.

The 1st wave is for the following categories of class D devices:

  • detection or quantification of markers of arbovirus infection
  • detection or quantification of markers of parasite infection
  • detection of blood grouping markers

Laboratories must submit applications to their Member State by 15 April 2025 (note: this date is indicative and laboratories should check with their specific Member State).

Member States must forward applications to the Commission by 6 June 2025.

The 2nd wave is for any of the following 8 categories of class D devices:

  • detection or quantification of markers of hepatitis or retrovirus infection 
  • detection or quantification of markers of herpesvirus infection 
  • detection or quantification of markers of infection with bacterial agents
  • detection or quantification of markers of arbovirus infection
  • detection or quantification of markers of respiratory virus infection
  • detection or quantification of markers of infection with haemorrhagic fever viruses or other biosafety level 4 viruses
  • detection or quantification of markers of parasite infection
  • detection of blood grouping markers

Laboratories must submit applications to their Member State by 15 January 2026 (note: this date is indicative and laboratories should check with their specific Member State).

Member States must forward applications to the Commission by 15 April 2026.

Conclusion

EURLs play a critical role in ensuring certain Class D IVDs are safe and effective. Although there are interim procedures in place for the conformity assessment of Class D IVDs, the IVD industry will benefit from the certainty of having enough designated EURLs to cover all categories of Class D devices.

Let’s hope this new call for further applications for designation of EURLs will provide additional resources the EU IVD industry desperately needs.

If you’re looking for a regulatory partner to offer compliance advise and support, get in touch with IVDeology today to begin your new partnership or email us at [email protected]

Exploring the EU COMBINE Programme
IVD & MDR NEWS

Exploring the EU COMBINE Programme

Posted on by Stuart Angell

Understanding and Bridging the Gap in Clinical Research The European Union’s (EU) healthcare l…

What Are EU Reference Labs for IVDs?
IVD & MDR NEWS

What Are EU Reference Labs for IVDs?

Posted on by Stuart Angell

EU Reference Labs for IVD’s – explained In vitro diagnostic medical devices (IVDs) play …

A review of the MHRA Fee Consultation
IVD & MDR NEWS

A review of the MHRA Fee Consultation

Posted on by Stuart Angell

Executive Summary The MHRA (Medicines and Healthcare products Regulatory Agency) held a public consu…

eQMS is Like a Chocolate Selection box: Choosing the Right Quality Management System
IVD & MDR NEWS

eQMS is Like a Chocolate Selection box: Choosing the Right Quality Management System

Posted on by Stuart Angell

Choosing an electronic Quality Management System (eQMS) might not sound like it has much in common w…

Understanding Companion Diagnostics: A Key to Personalised Medicine
IVD & MDR NEWS

Understanding Companion Diagnostics: A Key to Personalised Medicine

Posted on by Stuart Angell

The first companion diagnostic (CDx) was approved by the US Food and Drug Administration (FDA) in 19…

IVDeology now offering QMS Hosting Services!
IVD & MDR NEWS

IVDeology now offering QMS Hosting Services!

Posted on by Stuart Angell

One of the biggest challenges we see is the adoption of an effective Quality Management System (QMS)…

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eQMS is Like a Chocolate Selection box: Choosing the Right Quality Management System

Choosing an electronic Quality Management System (eQMS) might not sound like it has much in common with picking out a chocolate bar, but in many ways, the process is surprisingly similar. Both involve sifting through a variety of options to find the perfect fit for your specific needs and tastes. Just like when you’re deciding between dark, milk, or white chocolate, selecting the right eQMS requires considering your unique preferences, goals, and requirements.

Do you prioritize smoothness and simplicity, or do you need something with a bit more complexity and richness? In this blog, we’ll explore how the decision-making process for an eQMS mirrors the sweet (and sometimes overwhelming) experience of choosing your favourite chocolate bar. So, let’s unwrap the similarities and help you make a decision that’s both satisfying and beneficial

The eQMS Landscape

Here’s an interesting fact, just like chocolate, there are over 100 different versions of eQMS software available today! The remarkable thing is that you can build a compliant quality management system with any of these tools. You could even create one using basic platforms like SharePoint or Google Drive!

What Makes the Difference?

So what separates one eQMS from another? Different systems offer varying functionalities:

  • Some leverage AI (artificial intelligence) capabilities
  • Others focus on simplicity
  • Many interconnect with other business functions

It’s all about understanding what’s right for you and your organization. Quality management system software provides both a tool and a framework to build your QMS around. The work and effort required to build a QMS is largely driven by your specific company needs.

The Value of Expertise

This is where consultants become valuable. Through their careers, consultants experience different types of QMS systems built by different organisations at various stages of development. We can help you determine not only where to begin but also where you may want to go in the future. Our perspective and expertise can support you in developing a long-term strategy for quality planning and QMS implementation.

Our Recommended Options

While hundreds of options exist, here are three QMS software providers we regularly work with:

  1. Cognidox  – This is the system we use to build our own ISO-compliant QMS. It offers simple setup, ease of use, and scalability based on your company’s needs rather than forcing you into a predefined structure.
  2. TraceX – A robust alternative with its own strengths and considerations.
  3. ISMS – Another effective system that works well for certain organizational needs.

Both TraceX and ISMS work excellently, each with positives and negatives. The key is understanding what’s important to you, and we’d be happy to spend time with you to discuss these points. What works wonders for one organisation might not be suitable—or even detrimental—for another. This largely depends on each organisation’s unique needs, processes, and goals – just like how someone absolutely adores a coconut Bounty, whereas someone else, not so much!

Finding Your Perfect Match

Sometimes you want a Bounty, sometimes a Snickers, and sometimes you’re not even sure what you’re craving. But what you don’t want to do is settle for something medicore.

For more information on what’s right for you and how to effectively build a quality management system, get in touch with us on [email protected]. We can discuss these processes in more detail and help build you an effective, right-first-time quality management system tailored to your needs, after all, we maintain and work within our own QMS and know that a quality management system is for life, not just for your audits!

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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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IVDeology now offering QMS Hosting Services!

One of the biggest challenges we see is the adoption of an effective Quality Management System (QMS) too late in the design and development process of a medical device, especially for start up companies who don’t have the internal resources, funds or time to do so!

Great ideas and great products being delayed due to not having the quality and technical documentation required to meet regulatory requirements. Without a QMS, you don’t have a product! But we all know the challenge that companies face when they’re met with the dreaded question of ‘do you have a Quality management system?’

QMS Challenges we see faced by small businesses: 

  • Understanding the regulatory requirements – these go hand in hand
  • Finding the right QMS offering – this can be size, costing, adaptability, and so on!
  • Dedicating time and resources to the QMS
  • Developing Quality and Regulatory expertise 
  • Affordability of effective solutions 

Developing a QMS can be a significant challenge for a small business. It can be expensive and time consuming. Most QMS providers provide basic templates and technical support, but it takes time and specialist knowledge to build an effective QMS to allow business growth and regulatory approval. And on the other hand, some offer way too much for what small companies actually need right away, meaning you’ve overpaid for way more than you need, which can lead to being overwhelmed and frustrated.

So what are the benefits of a QMS? 

  • Meets regulatory requirements – again, they go hand in hand
  • Enables growth and expansion 
  • Improves operational efficiency 
  • Reduces product and business risk 
  • Build customer confidence 
  • Offers a competitive advantage 

Read our previous blog: “A QMS isn’t just for IVDR conformity assessment…. it’s for life!” to learn more about how implementing and maintaining a QMS that works for you is so important

 IVDeology have a proven track record supporting our customers build, host and maintain a quality management system specific to their industry: 

  • ISO 9001 – General quality management system, ideal for service providers 
  • ISO 13485 – Specific for Medical Devices and In vitro diagnostic manufacturers 
  • ISO 17025 – Quality Management System for testing laboratories 

Our aim is to provide a common-sense approach to quality compliance, and we understand that start up companies cannot afford all the bells and whistles for a fully fledged QMS that they just can’t and won’t need to utilise yet.

We now offer eQMS hosting, a solution that we feel every small business can benefit from. But what is it?

IVDeology use Cognidox, an eQMS platform that allows us to build our system round our own needs, we can create templates, process with change controls, manage procedures and personalise it to what we deem important for us.

We have the ability to host your company within our eQMS system, a safe and secure, private account within Cognidox that allows you to begin with 1-2 members to start building your Quality management system.

Benefits of us hosting you within Cognidox:

  • You have access to all our templates for documents and procedures, and these can be tailored to you and your product(s) and processes
  • We use Cognidox! You can receive training and a demo of the systems, and you can add on adhoc support from us if you need it later on
  • It can be as basic as you like for what you need now to comply with the regulations
  • Buildable and manageable, both for content but also adding users if and when your team grows
  • You can capture your QMS and move it over to your own system whenever you decide you can begin to host your own eQMS internally – so you won’t lose any data or have to start again
  • Secure, reliable system that auditors can be given access to

We have been onboarding several customers who are excited to be hosted in our system, and we’d be more than happy to demonstrate or give a free demo access for those who would like to try it out, you can email us on [email protected], drop us a message on LinkedIn, or book right into our calendar by clicking here: Bookings

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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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Utilisation of GMDN Codes for IVDs in TGA Device registration

The Global Medical Device Nomenclature (GMDN) system plays a crucial role in the regulatory landscape for in vitro diagnostic (IVD) medical devices. In Australia, the Therapeutic Goods Administration (TGA) mandates the use of GMDN codes for the registration of IVDs. This blog explores the significance of GMDN codes, their application in TGA device registration, and the benefits they offer to manufacturers and regulators alike.

Understanding GMDN Codes

GMDN codes are a standardized system of terms used to identify medical devices. Each code consists of a unique five-digit number, a term name, and a definition. The GMDN system is maintained by the GMDN Agency, a non-profit organization that collaborates with regulatory authorities worldwide to ensure the nomenclature remains up-to-date and relevant.

Importance of GMDN Codes in IVD Registration

The use of GMDN codes is essential for several reasons:

Application of GMDN Codes in TGA Device Registration

The process of registering IVDs with the TGA involves several steps, with GMDN codes playing a pivotal role:

Benefits of Using GMDN Codes

The utilisation of GMDN codes offers several benefits to manufacturers, regulators, and healthcare providers:

Challenges and Considerations

While the use of GMDN codes offers many benefits, there are also challenges and considerations that manufacturers must be aware of:

Conclusion

The utilisation of GMDN codes is a critical component of the regulatory framework for IVDs in Australia. By providing a standardized system for identifying and classifying medical devices, GMDN codes help ensure regulatory compliance, enhance traceability, and facilitate global harmonization. For manufacturers, understanding and effectively using GMDN codes is essential for successfully navigating the TGA device registration process and bringing safe and effective IVDs to market.

By embracing the use of GMDN codes, manufacturers can streamline their regulatory processes, improve market access, and contribute to a safer and more transparent healthcare system. As the regulatory landscape continues to evolve, the importance of GMDN codes in ensuring the safety and efficacy of medical devices will only continue to grow.

If you’d like friendly compliance advise then please don’t hesitate to reach out to us at [email protected] or book in with our team at a time that suits you for a teams call by clicking here, and make sure to follow up on LinkedIn to be notified with IVD industry news and updated

Sources:

The use of GMDN codes for IVD medical devices in Australia

The use of GMDN codes for IVD medical devices in Australia 

Devices – GMDN search – Therapeutic Goods Administration

EMDN codes (europa.eu)

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Person Responsible for Regulatory Compliance under Article 15 of the IVDR

In the realm of In-vitro diagnostic Medical devices, regulatory compliance is non-negotiable. The European Union In Vitro Diagnostic Regulation (IVDR) have set stringent standards to ensure the safety and efficiency of medical devices. A pivotal role introduced by these regulations is the Person Responsible for Regulatory Compliance (PRRC). The PRRC is tasked with ensuring that all regulatory requirements are met, from product development through to post-market surveillance. This role is essential for maintaining the quality and safety of medical devices, and compliance with these regulations is mandatory for companies operating within the EU.

However, for many companies, especially small to medium-sized enterprises (SMEs), the challenges associated with maintaining an in-house PRRC can be daunting. This is where outsourcing the PRRC role comes into play. Article 15 of the IVDR allows the utilisation of external PRRCs for micro and small enterprises. IVDeology have a proven track record in providing expert regulatory expertise to SMEs.

Company categoryStaff headcountTurnoverorBalance sheet total
Medium-sized< 250≤ € 50 m≤ € 43 m
Small< 50≤ € 10 m≤ € 10 m
Micro< 10≤ € 2 m≤ € 2 m

Source: SME definition – European Commission (europa.eu)



Access to Specialised Knowledge

One of the most significant benefits of outsourcing the PRRC role is the access to specialized expertise. Regulatory compliance is a complex and ever-evolving field, requiring a deep understanding of both the regulations and the specific products being developed. Outsourcing to a third-party provider ensures that the PRRC has the necessary experience and knowledge to navigate these complexities. These experts are typically well-versed in the intricacies of the IVDR, and they stay abreast of the latest developments in the regulatory landscape. This level of expertise can be particularly advantageous for companies developing innovative or highly specialized products, as it ensures that all regulatory requirements are met to the highest standards.



Saving Time and Money in the Long Run

Hiring and training an in-house PRRC can be a costly endeavour. The recruitment process itself can be expensive, and once a suitable candidate is found, they need to be trained and continuously educated on the latest regulatory requirements. Additionally, the salary for an experienced PRRC can be substantial. By outsourcing this role, companies can reduce these costs significantly. Third-party providers typically offer their services on a contract basis, which can be more cost-effective than employing a full-time, in-house PRRC. This approach allows companies to allocate their financial resources more efficiently, investing in other critical areas of their business such as research and development, marketing, or expanding their product portfolio.

Our aim is to work with our clients to develop a succession plan for the eventual internal replacement of our virtual PRRC. We will train and mentor the identified internal team members so build the experience required to meet the requirements of Article 15.

Letting Experts Handle Compliance

Regulatory compliance, while essential, is often not a company’s core activity. For many organizations, particularly SMEs, the primary focus is on developing innovative products, enhancing customer experiences, and growing their business. We understand that some organisations may not want to build their regulatory team internally, so we always try to build long term relationships with our customers for continuous support. By outsourcing the PRRC role, companies can allow their internal teams to focus on these core activities. This not only enhances productivity but also ensures that the regulatory compliance function is handled by experts. This separation of duties can lead to better outcomes in both regulatory compliance and overall business performance.

“Regulatory compliance is the responsibility of everyone in the organisation, the PRRCs core responsibility is to observe, reflect and advise on the overall compliance state of the organisation to senior management”

Adapting to Changing Needs

The regulatory landscape is constantly changing, and the demands placed on the PRRC can vary significantly over time. Outsourcing the PRRC role offers companies the flexibility to scale their regulatory compliance efforts up or down as needed. For instance, during periods of intensive product development or regulatory scrutiny, a company may require more comprehensive compliance support. Conversely, during quieter periods, the level of support needed may be reduced. Outsourcing allows companies to adapt to these changing needs without the long-term commitments associated with employing a full-time, in-house PRRC. This flexibility can be particularly beneficial for companies with fluctuating workloads or those operating in highly dynamic industries.

Ensuring Compliance and Avoiding Penalties

Non-compliance with regulatory requirements can result in severe penalties, including fines, product recalls, and even the suspension of business operations. The PRRC plays a crucial role in mitigating these risks by ensuring that all regulatory requirements are met and that any potential issues are addressed promptly. Outsourcing the PRRC role to a reputable third-party provider can enhance this risk mitigation process. These providers have the experience and resources to conduct thorough compliance assessments, implement robust quality management systems, and respond swiftly to any regulatory changes or issues. This proactive approach can help companies avoid the costly consequences of non-compliance and maintain their reputation in the market.

Staying Ahead of Regulatory Changes

The IVD industry is characterized by rapid technological advancements and frequent regulatory updates. Staying ahead of these changes is critical for maintaining compliance and achieving business success. Outsourcing the PRRC role to a third-party provider ensures that companies have access to the latest regulatory knowledge and best practices. These providers invest in continuous education and professional development to stay current with regulatory changes. By leveraging their expertise, companies can continuously improve their compliance processes, adapt to new regulations seamlessly, and maintain a competitive edge in the market.

Giving you a Strategic Advantage

Outsourcing the PRRC role offers numerous benefits for companies operating in the medical device industry. From accessing specialized expertise and achieving cost savings to enhancing focus on core activities and adapting to changing needs, outsourcing provides a strategic advantage. By partnering with a reputable third-party provider, companies can ensure that their regulatory compliance efforts are handled by experts, mitigating risks and driving continuous improvement.

In an industry where compliance is critical to success, outsourcing the PRRC role can be a game-changer, allowing companies to navigate the complexities of regulatory requirements with confidence and achieve their business goals.

For further information on how we can support you, please contact us.

Written by Stuart Angell, Co-founder and Director of IVDeology, part of TEAM PRRC

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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