Tag: IVDR

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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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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

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The AI Airlock Programme – The Potential of AI in Healthcare

The Potential of Artificial Intelligence in Healthcare

Artificial Intelligence (AI) in healthcare has the potential to improve patient outcomes, for example, by improving diagnosis or treatment selection. However, it is difficult to assess new and innovative AI technology using traditional trial techniques.

The AI Airlock

In Oct 2023, the Medicines and Healthcare products Regulatory Agency (MHRA) announced that they would set up a regulatory sandbox, the AI Airlock. This will provide software and AI medical device developers with virtual testing environments in which they can design and implement test protocols for their devices. There will be three different testing environments (Simulation airlock, Virtual airlock and Real-world airlock) and different factors will determine which testing environment will be most appropriate to each candidate and their device. MHRA’s AI Airlock webinar, presented in July 2024, provides more details about the AI Airlock.

By bringing together expertise from innovators, regulatory organisations including Approved Bodies, Government, the NHS and academia, the AI Airlock pilot program will allow for a collaborative approach. This will enable developers to generate robust evidence for their technology and assist in safe development and deployment of such devices.

Devices will need to meet one or more of the following eligibility criteria:

  • Has the potential to deliver benefits for patients
  • Device or concept application is innovative
  • Presents a regulatory challenge
  • Device is conceptually/developmental robust and ready to be trialled.

Four to six candidates will be recruited to join the pilot cohort and there is no fee for application or participation in the pilot program. Candidates will need to commit resource to the pilot program and are expected to fund their own studies and delivery of any Airlock testing, including accessing relevant data sets. Whilst this pilot phase of the AI Airlock will run until April 2025, candidates should expect to complete their individual Airlock testing within 6 months.

Learnings from this first pilot programme will inform future Airlock phases and the outputs will include:

  • Project Reports from each candidate project team,
  • An Airlock Sandbox report of learnings to inform future guidance and implications for the regulatory framework,
  • A programme evaluation report sharing learnings on the use of regulatory sandboxes. 

Application to the MHRA

This is a great chance for software and AI medical device developers to obtain advice from regulators whilst they experiment and testing their device in controlled and safe environments. Participation in the programme also offers developers an opportunity to have a part in informing the future GB regulatory framework on software and AI medical devices.   

Candidates can now apply to the MHRA to join the AI Airlock pilot program by completing the application form and returning it to [email protected]  before 07 October 2024.

If you’re looking at developing an AI product, or any other diagnostic device, please do get in touch as we can support you from idea to design and market – you can contact us here for a complimentary introduction chat

Written by Tsz Wai Woo, Regulatory specialist at IVDeology

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Near-patient Testing – Is it the Future for Diagnostics?

There has been a lot of discussion surrounding the focus of treatment within primary care.  The NHS published guidance in August 2023 for integrating point of care IVD’s (NHS England » Integrating in vitro point of care diagnostics: guidance for urgent community response and virtual ward services).  The Labour Party’s recent manifesto for the 2024 General Election stated that “Labour’s reforms will shift our NHS away from a model geared towards late diagnosis and treatment, to a model where more services are delivered in local communities” and “The National Health Service needs to move to a Neighbourhood Health Service, with more care delivered in local communities to spot problems earlier. To achieve this, we must over time shift resources to primary care and community services.”  (Change Labour Party Manifesto 2024).  Whilst this is good news for patients, it is not as simple as changing the location of the testing – there will be implications for the IVD industry in order to meet these proposals.

The In Vitro Diagnostic Medical Devices Regulation (Regulation (EU) 2017/746, ‘IVDR’) defines a “device for near-patient testing” as “any device that is not intended for self-testing but is intended to perform testing outside a laboratory environment, generally near to, or at the side of, the patient by a health professional.”

During Design & Development, IVD manufacturers have to determine the use environment and end users within their intended purpose.  It is then their responsibility to demonstrate that the device is safe and effective when used in these environments by these intended end users and therefore there will be a number of additional requirements that need to be considered for devices intended for near-patient testing.

Performance Requirements:

The performance testing conducted will need to demonstrate that effective and reliable testing outside of the traditional controlled laboratory environments.  Considerations such as the following will need to be considered:

  • Use Environment Testing:

Annex I section 9.4 states “The characteristics and performances of the device shall be specifically checked in the event that they may be affected when the device is used for the intended use under normal conditions:

(b) for devices for near-patient testing, performances obtained in relevant environments (for example, patient home, emergency units, ambulances).”

Testing of the device will therefore need to be conducted in the intended use environments. Manufacturers will need to show that the test can be used reliably in the environments that they indicate that the test can be used in. This could be, for example, doctor’s surgeries, A&E departments, patient’s homes or in ambulances.  Any conditions specific for these environments would need to be considered e.g. vibrations or temperature fluctuations for devices intended to be used on an ambulance.

  • Usability Studies:

Annex I section 19.1 states that “Devices intended for self-testing or near-patient testing shall be designed and manufactured in such a way that they perform appropriately for their intended purpose taking into account the skills and the means available to the intended user and the influence resulting from variation that can be reasonably anticipated in the intended user’s technique and environment. The information and instructions provided by the manufacturer shall be easy for the intended user to understand and apply in order to correctly interpret the result provided by the device and to avoid misleading information. In the case of near-patient testing, the information and the instructions provided by the manufacturer shall make clear the level of training, qualifications and/or experience required by the user.

It is important for manufacturers to have designed their device in such a way as to ensure that the intended end users can successfully use the device.  Therefore it is vital that manufacturers conduct usability studies with their target end users who are often not laboratory trained personnel.  This can then be used to demonstrate that consistent results can be obtained by these target end users, determine if the instructions provided with the device are adequate and help to identify if any training is required for the end users before the device can be used reliably.

Labelling Requirements:

The IVDR has also introduced specific labelling requirements for NPT (near patient testing) devices, including:

  • Devices labelled as Near-Patient Testing: The device label must indicate that the device is for near-patient testing.  Although there are currently no symbols for this within ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer, MedTech Europe has provided some suggested symbols that can be used to indicate near-patient testing (New IVD symbols for compliance with the IVDR – MedTech Europe).
  • Individual Instructions for Use: Each individual device must be accompanied by its own instructions for use (IFU).  For devices for professional use within a laboratory setting, if multiple devices were supplied then a single copy of the IFU could be provided if agreed by the purchaser.  This is not allowed for devices intended for near-patient testing.
  • Paper-Based Instructions: According to Annex I 20.1(f) of the IVDR, the instructions for use must be provided in a physical paper format for near-patient tests, and, unlike laboratory based professional use devices, cannot be provided in electronic format.
  • Language Requirements: The languages that the Member States require for the device label and instructions for use for near-patient testing may be different to those for professional use only tests.  This may add more translation costs on to manufacturers to access different markets.

The labelling provided must be appropriate to the device, its intended use, and the technical knowledge, experience, education, or training of the intended users.  This will need to be considered by manufacturers when designing the labelling and tested during usability studies.

Notified Body Assessment

Whilst devices for near-patient testing are classified in their own right according to Annex VIII rule 4(b), the notified body assessment is slightly different.  For Class B & Class C devices, the technical documentation of all devices for near-patient testing has to be assessed rather than the notified bodies sampling one technical file per generic device group or device category. Where a manufacturer has a number of devices for near-patient testing the increase of upfront cost to have their devices assessed will need to be considered.

Final thoughts

Whilst near-patient testing seems like a real win for patients and the direction of travel that the diagnostic industry is heading, this does provide some challenges for manufacturers.  The additional burden to demonstrate that the device is effective and reliable when used outside of a laboratory setting and the potential increased upfront costs of conformity assessment is something that needs to be considered before being able to place the device on the market.  For Great Britain, although the UK MDR 2002 does not specifically call out devices for near-patient testing currently, the indications from the MHRA on the future regulations is that it will be similar to the IVD Regulation with the new Essential Requirements being based on the General Safety & Performance Requirements.  This is likely therefore to mean that the additional requirements for these types of devices will also be required here.  However, if done correctly, near-patient testing will enable quicker diagnoses for patients and hopefully therefore better patient outcomes, which is ultimately what the IVD industry wants to support.

If you’d like to discuss near-patient testing or any of the compliance services that come along with it, from design and development to regulatory services, you can speak to us by dropping an email to [email protected] or book time with us via this link for when best suits you

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Regulatory Strategy: What is it, and why do you need one?

If you are planning to place an in vitro diagnostic medical device (IVD) onto the market, It is critically important that you consider your regulatory strategy at the earliest opportunity. In our experience, building an effective strategy for regulatory strategy can be the difference between achieving product market access or not.

What is a Regulatory Strategy?

A Regulatory Strategy is a documented plan of all regulatory activities and deliverables that are required to be performed by a Legal Manufacturer. It should also align with the overall objectives of your organisation as defined within your vision, mission and business plan.

This should lay out a framework for placing an IVD on the market or markets depending on your commercial opportunity. Typically, the organisation will identify a priority list of countries where it is intending to sell the devices, the regulatory strategy describes the order of which these countries are being registered in.

Once the device is on the market, the plan continues to drive the regulatory surveillance mechanisms described as part of Post Market Surveillance as part of your ISO 13485 Quality Management System. It should also include a plan for meeting any transitions to updated regulatory requirements or ISO standards associated with the device.

Why do you need one?

For devices being placed on the European market under European IVD Regulation (IVDR), Article 10 (Manufacturers Obligations) describes the requirement for maintaining a regulatory strategy:

The quality management system shall address at least the following aspects:

(a) a strategy for regulatory compliance, including compliance with conformity assessment procedures and procedures for management of modifications to the devices covered by the system;

Furthermore, Annex IX requires the Quality Management System to include within its procedures, “a strategy for regulatory compliance, including processes for identification of relevant legal requirements, qualification, classification, handling of equivalence, choice of, and compliance with, conformity assessment procedures.”

In addition to the regulatory expectations, it is also hugely beneficial to plan and document the path to device registration and beyond. It also offers clear evidence to investors that the route to market has been considered and is planned.

When should you create one?

Typically, the regulatory strategy is formed, at a basic level, early on within the design and development process. Once your business vision and mission has been identified, and your business plan establishes the potential for the development of an IVD, the route to achieving that vision should now be considered.

Developing a regulatory strategy is an iterative process as many of the elements required will not have been considered or nailed down. This is entirely normal, but it is important to do the groundwork and start somewhere!

Our Approach to Regulatory Strategy

Education of the basic IVD requirements

A regulatory strategy can take many forms and will grow as you progress through the D&D process. We prefer to work with our SME customers and provide a regulatory strategy blended with some in-house training (virtually or on your site globally) on the key IMDRF principles, definitions and concepts of the regulation of IVDs. We aim to cover the main markets notably the EU, UK and MDSAP countries, to give you the best possible start in understanding what you need to know before developing your device.

Evaluate device type and classification and routes to market

Using your existing ideas of what your device is, and how it should be used, we can help you construct an Intended Purpose Statement, which is the bedrock of how IVDs are classified and assessed. We will guide you through how to assign device nomenclature including GMDN or EMDN codes to understand the routes for conformity assessment and submission requirements, EU Notified Bodies or UK Approved bodies as required. The output of this evaluation will be detailed within a Regulatory Strategy Report, which you can share with your wider team and investors.

The strategy should sit alongside the Quality Plan, used to identify and plan the implementation of a Quality Management System (QMS).

End to end planning

We can incorporate our knowledge to help you understand an estimation of design and development stages with associated costs. This will help you identify when you need to grow and when to secure additional funding. Our experience however is that bringing an IVD to is never a straight line and your regulatory strategy may change over time. We can give you the background knowledge and tools along the way to navigate the complexities and challenges that you may face.

Be part of the journey with you

As part of the Abingdon Health group, IVDeology can spend time with you to understand, explain and build your regulatory strategy together that works towards your timelines and business project goals, but not only that, we can work together as a strong technical team with your business to support any gaps you may need. IVDeology building your regulatory plan with you means you always have a supportive hand for any questions, queries or concerns every step of the way with a team who knows your goals and vision.

If you’d like to discuss a regulatory plan, whether you have an existing one already or starting from scratch, you can book a call here, or email us on [email protected] and we’d be happy to help!

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US IVD Classification – How different can it be?

IVDeology have decades of IVD (invitro diagnostics) compliance support experience within the Quality and regulatory industry, with backgrounds from microbiology to lab based experience, and recently becoming part of the Abingdon Health PLC to offer a more holistic range of services from cradle to grave of diagnostic products. Co-founder and Director of training Nancy Consterdine talks about the US classifications of devices, having worked recently with US 510K submissions including pre-submissions.

The Global Harmonisation Task Force (GHTF) published their classification guidance in June 2006 proposing a risk based, 4 tier classification system for In Vitro Diagnostic Devices. This guidance has been widely used since 2006 for new regulatory systems being set up around the world e.g. the IVD Regulation in Europe 2017/746.

However, the United States of America (US) had already introduced a 3-tier risk-based classification system back in 1976 with the amendments to the Food, Drug and Cosmetics act (FD&C) to include medical devices. This system has now been in place for 48 years, despite amendments having been made around the regulatory pathways e.g. introduction of the 510K De Novo program, enacting of the Small Business Determination program and electronic submission processes. So, how does the classification system work currently and what are the future changes that the FDA are proposing?

Figure above shows class |, || and ||| and risk (explained below)

Class 1

  • Low to Moderate Risk devices e.g. Transport culture medium, immunoelectrophoretic equipment, Biological stains
  • Subject to General Controls (Regulatory Requirements which apply to all medical devices) all covered under a quality management system:

    – Registration of producers of medical devices.
    – Notifications and other remedies e.g. recall.
    – Records and reports on devices e.g. adverse event report.
  • Manufacturers are still visible to FDA and may be subject to audit.
  • Devices may be exempted from a General Control as stated in the classification regulation for that device e.g. they may be exempt from GMP other than keeping records and complaint files.
  • Devices are submitted via the 510K pre-market notification process but some are exempt.

Class II

  • Moderate to High Risk e.g. Blood Culture Assay, Rubella ELISA Test
  • Subject to General Controls and Special Controls:
    – Device specific
    – Evidence of meeting performance standards
    – Post market surveillance
    – Adherence to guidelines
    – Special labelling requirement
  • General Controls are considered insufficient to provide assurance of safety and effectiveness.
  • Devices are submitted for pre-market notification via 510K process.

Class III

  • High Risk e.g. Cancer Biomarker companion diagnostic assay
  • Subject to General Controls and Premarket Approval:
    – Quality Management processes and controls
    – Software design, development and cyber security
    – Analytical Verification data
    – Clinical Performance Data
  • Pre-Market Approval (PMA) application is required

Recent Developments

In January 2024, a press release from Jeff Shuren, the director of the Centre for Devices and Radiological Health (CDRH) announced the intent to initiate the reclassification process for most IVDs which are currently class III (high risk) into class II (moderate risk). They identified that the majority of these tests are infectious disease and companion diagnostic IVDs. This is in line with the FDA least burdensome approach allowing manufacturers of some devices to seek marketing clearance through the 510K premarket notification route. In the release it also talked to the FDA desire to encourage more manufacturers to develop the test and in turn increase competition and access to these important tests.

The process of reclassification has already started with a panel meeting in September 2023 identifying 3 types of infectious disease diagnostic IVDs

  • Nucleic acid and serology based IVDs to aid diagnosis of Hepatitis B Virus infection and management of infected patients.
  • Serology based IVDs for detection of human parvovirus B19.
  • Cell mediated immune reactivity IVDs to aid identification of in vitro responses to peptide antigens associated with TB infection.

Conclusion

The IVD industry can only welcome these moves by the FDA in conjunction with the amendment of the Quality Management System regulation (QMS) to be more closely aligned to the ISO 13485:2016 standard. It makes the USA a far more inviting prospect for initial market authorisation applications. The costs are transparent, the timelines are clearly identified and there is a process in place to present and discuss the device with the FDA in a pre-submission meeting.

There are however other considerations that need to be taken, Jeff Shuren has recently announced his retirement and Dr Michelle Tarver will assume the role of CDRH Acting Director. Also, there are presidential elections this year, will these changes impact the current trajectory of the CHRH? We at IVDeology will continue to monitor the situation across the pond, it is evident that since Brexit the UK government has been eager to foster recognition of other regulatory body approvals and it does feel that the movement of the FDA approval process is going in the same direction as that of the UK MDR.

Next steps to consider, and how we can help.

IVDeology Ltd can support with all of the above, please contact us for a friendly conversation to identify how we can support you with your compliance journey via our contact page