Tag: QMS

Posted on by

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

Posted on by

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!

Posted on by

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

Posted on by

MDSAP: Explaining the complexities and importance

The Medical Device Single Audit Programme (MDSAP) is a system by which the participant competent authorities to recognise the quality management certification (as awarded after audit against both ISO 13485 and county specific requirements) from a single authority for medical device and in-vitro diagnostic medical device (IVDs) legal manufacturers.

The programme has been established by the International Medical Device Regulators Forum (IMDRF) and is intended to provide a harmonised approach to demonstrating the compliance of the Quality Management System (QMS) using a globally recognised approach.

The MDSAP was developed by the IMDRF to:

  • Enable appropriate regulatory oversight of medical device manufacturers’ quality management systems while minimizing regulatory burden on industry;
  • Promote more efficient and flexible use of regulatory resources through work sharing and mutual acceptance among regulators while respecting the sovereignty of each authority;
  • Promote globally, in the longer term, a greater alignment of regulatory approaches and technical requirements based on international standards and best practices;
  • Promote consistency, predictability and transparency of regulatory programs by standardizing;

    1. the practices and procedures of participating regulators for the oversight of third party auditing organizations, and
    2. the practices and procedures of participating third party auditing organizations

Regulatory Authorities

MDSAP consists of Regulatory Authority Council Members, Observers and Affiliate members:

Regulatory Authority Council Members:

  • Therapeutic Goods Administration of Australia
  • Brazil’s Agência Nacional de Vigilância Sanitária
  • Health Canada
  • Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency
  • U.S. Food and Drug Administration

The RAC is the decision-making body of MDSAP and consists of representatives from all regulatory authorities that are members of the RAC. The RAC provides direction, oversight, and resources to support the MDSAP development, implementation, maintenance, and expansion.

Observer Members:

  • European Union (EU)
  • Singapore’s Health Sciences Authority (HSA) (NEW)
  • United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA)
  • The World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Programme

The observers do not observe RAC members and do not attend RAC meetings, but they do observe and contribute the RAC activities. Both the EU and UK have been Observers for over 2 years, and as such, can apply to become full RAC members if desired.

Affiliate Members:

  • Argentina’s National Administration of Drugs, Foods and Medical Devices (ANMAT)
  • Ministry of Health of Israel
  • Kenya’s Pharmacy and Poisons Board (New member)
  • Republic of Korea’s Ministry of Food and Drug Safety
  • Federal Commission for Protection from Sanitary Risks (COFEPRIS) of Mexico
  • TFDA – Taiwan Food and Drug Administration

Affiliate members are not members of the RAC or an Official Observer, but engages in MDSAP, demonstrates understanding of MDSAP and utilizes MDSAP audit reports and MDSAP certificates for evaluating compliance with applicable medical device requirements, including a manufacturer’s quality management system, under the Affiliate Member’s regulatory framework.

The application of the MDSAP Programme

The utilisation of the MDSAP programme, and the resulting certificates are utilised differently depending on each Competent Authority as dedicated by each regional requirement.

Regulatory AuthorityUtilisation of MDSAP
AustraliaMDSAP audit report is used as part of the evidence that it has assessed for compliance with medical device market authorization requirements, unless excluded or exempt from these requirements.
BrazilANVISA utilizes the outcomes of the program as part of the pre-market and post market assessment.  
CanadaManufacturers intending to place a product on the market in Canada must have an MDSAP Certification issued by an Auditing Organization.
JapanThe Ministry of Health, Labour and Welfare (MHLW) and Pharmaceutical and Medical Devices Agency (PMDA) utilize these audit reports in pre-market and post-market audits.
United StatesU.S. FDA will accept the MDSAP audit reports as a substitute for FDA routine inspections under a 510(k) device application. The use of MDSAP is not utilised for pre-approval or post-approval inspections for Pre-Market Approval (PMA) applications.

The regulations for the above Regulatory Authorities are available (English) from the USA FDA Website.

The use of the MDSAP programme and certification will be greater utilised as he programme expands and more regulatory authorities recognise the value in this process.

The MDSAP Audit Cycle and Auditing Organisations

Auditing Organisation are certification bodies that have successfully applied, and been recognised by the MDSAP programme to audit medical device manufacturers against the requirements of the MDSAP programme. The current list includes many European Notified Bodies (under EU IVDR), and UK Approved Bodies (under UKCA) and are globally recognised.

The MDSAP audit is typically build on to the existing ISO 13485 certification audit of the Quality Management System with a 3-year audit cycle.

Figure 1 MDSAP Certification Cycle

Will MDSAP come to the EU and UK?

There is much talk regarding the use of MDSAP by the EU and UK. While I am a strong advocate in global harmonisation, the existing members joined MDSAP to find a harmonised way to create a robust process for standardising QMS requirements from a position where they needed to find a suitable and robust process. Regardless of the state of play in the EU and UK, both regions already have robust mechanisms for the surveillance of ISO 13485, largely provided by the technical and commercial expertise of EU and UK Notified Bodies and Approved Bodies (as part of ISO13485 certification/IVDR conformity assessment), so the utilising MDSAP would be less impactful.

The opportunity would be regarding the outward facing regulatory convergence of EU and UK to align, and reduce burden for accessing other markets, MDSAP would be a good way of doing this. We have seen TGA become well placed in MDSAP/IMDRF mainly utilising CE marking for supporting AUS market access.

The challenge with MDSAP is that each jurisdiction has specific requirements, which make the MDSAP process clunky. The key to an improved model is to remove local requirements as much as possible, however this is dependent on global alignment at a political as well as regulatory level.

References

If you’d like to discuss MDSAP with us, you can book a call with the IVDeology team as we navigate this new programme and what it means for you as a manufacturer or provider of IVD’s and devices with each of the individual requirements. Being part of BIVDA (British In Vitro Diagnostics association), we’re in a great position to be able to receive and understand information and distribute to our networks as it comes, in a reliable and digestible way.

Or if you’d like support in other areas of Quality assurance or regulatory compliance, we’d be happy to chat with you. We can support with Quality management system implementation, transfer or uplifting.

We’ll be keeping you up to date with MDSAP news on our LinkedIn page and website, so do follow up on our socials and keep up to date with IVDeology along with Abingdon Health PLC.

Written by Stuart Angell, MD and Co-founder of IVDeology and IVDeology UKRP

Posted on by

A QMS isn’t just for IVDR conformity assessment…. it’s for life!

In this blog we are going to discuss our views on the benefits and need to have and maintain your Quality Management System (also known as a ‘QMS’)

IVDeology have decades of experience supporting IVD companies and manufacturers all across the globe with their Compliance journey within Quality and regulatory, and Jo Angell, our Quality and operations coordinator at IVDeology talks about the importance of a QMS that can grow with you, having experienced managing IVDeology’s own Quality management system internally at IVDeology as well as setting up and hosting other companies QMS.

What is a QMS?

  • Quality is defined as the “degree to which a set of inherent characteristics of an object fulfils requirements” [ISO 9000:2015, 3.6.2]
  • A management system is a set of interrelated or interacting elements of an organization to establish policies and objectives, and processes to achieve those objectives. [ISO 9000:2015, 3.5.3]

The 2 main standards covering QMS for Medical Device (including In Vitro Diagnostic (IVD)) manufacturers are:

For medical laboratories, where IVDs are used or developed as a Lab Developed Test (LDT) the additional ISO 15189:2022 Medical laboratories — Requirements for quality and competence, can be utilised.

Why have one?

It is true that establishing and maintaining a Quality Management System requires additional investment, both financially and from a resource perspective, there are substantial benefits for having one:

  • Demonstrates to customers your commitment to quality
  • Standardisation of processes
  • Consistent training throughout the organisation
  • Ensures continuous improvement
  • Improved productivity and efficiency
  • Reduced waste steps
  • Improved customer satisfaction
  • Ensures controls are in place to make safe and effective products
  • Identification and control of risks
  • Control and assessment of suppliers

An effective QMS can provide a solid foundation of quality and safety in a consistent and well-organised ecosystem

You will need one if you are intended to place IVDs on market

For the EU the IVDR states that: “all manufacturers should have a quality management system and a post market surveillance system in place which should be proportionate to the risk class and type of device in question”

As a legal manufacturer of an IVD or medical device a QMS must be implemented and compliant to the applicable regulations where you place your device on market. For EU CE marking under the new IVDR transitional timelines,  this shall be no later than 25th May 2025. This is less than 12 months away!

Who’s responsible for maintaining the QMS?

Typically, this is the role of the Quality contact in any organisation. However, establishing a quality culture, and ensuring the QMS has been built, and maintained effectively is the role of the organisations top management. They need to demonstrate leadership and a commitment to the QMS.

Maintaining your QMS

A good and efficient QMS supports your company with the best way to do things, by having input from across the organisation these processes can be agreed on and will be committed by everyone in your organisation. An effective QMS should be everyone’s objective, not just Quality!

A QMS should grow as your organisation grows

A QMS is not a one size fits all, it needs to build and grow with your organisation and will never be a finished article, it should always be continually improving. The complexity and scope should also reflect the nature and size of your organisation.

eQMS are great but…

Electronic QMS software provide a great tool, but you need to build the QMS with you in mind. These will never be an off the shelf ready to go package. All templates will need to be customised and adapted to fit your organisation and processes, otherwise the QMS just won’t work.

You have the certificate and placed the product on market – but what next?

In a previous blog, we discuss the challenge of Post Market Surveillance, and what is expected , mainly from a UK point of view:

“The manufacturer shall institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase and to implement appropriate means to apply any necessary corrective actions, taking account of the nature and risks in relation to the product.”

This means that as manufacturers you still need to be collecting data on how effective your device is – monitoring your customer complaints and feedback, any incident reporting, your manufacturing information, looking at your trends, to mention just a few possible sources of information. This data should then be reviewed to determine whether any updates are required and if so, these actions should be documented appropriately. Potential updates could impact your:

  • Risk Management File – Is the Severity of the risks impacted? Does it impact your frequency of occurrence of known risks? Are there new risks that you haven’t included?
  • Instructions for Use & Labelling – Do you need to add additional warnings? Are your instructions clear enough?
  • Training – Is any training that you provide sufficient? Is additional training necessary for your users?
  • Other products – Does the issue impact other devices you manufacture

5 Top Tips from the team on how to effectively build and maintain a QMS

  1. Get buy in from senior management – if they don’t understand what a QMS is, and why it is important (and not just required), it will never be supported and managed effectively.
  2. It is a growing, living thing, the more you feed it, the stronger and more robust it will be. It needs love and attention to get the most out of it.
  3. QMS software will save you time and money in the long run.
  4. Most non-conformances are raised against your own processes, not the standard. Make your procedures as simple and as clear as possible, ensure the people doing the work are involved in creating the processes, they know their processes the best!
  5. Use internal audits to strengthen and improve your QMS and use your business risk assessments as a tool to help the business overcome challenges and move on new opportunities

If you’ve got this far, you’ll hopefully understand the importance of a fully functioning and certified QMS but may be worried about where to start. At IVDeology (an Abingdon Health company) we offer full service solutions for QMS amongst our nose-to-tail regulatory support services. We can support you by:

  1. Being Legal Manufacturer (all QMS responsibility lies with us)
  2. Build your QMS for you
  3. Host your QMS within our ISO certified system or we can put you in touch with Cognidox, a QMS system we use at IVDeology ourselves

Our team of experts have a proven track record for the development and maintenance of Quality Management System ranging from SME to large IVD manufacturers. To hear more about how we can support, please contact [email protected] or click ‘get in touch’ to book in with our customer success coordinator

Posted on by

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

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

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

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

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

The UKRP responsibilities include:

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

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

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

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

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

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

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

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

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

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

 

Posted on by

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


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

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

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

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

Exceptions to the Rule

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

LDTs marketed before Final Rule was published on 06 May 2024

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

Tests meeting unmet needs, Nonmolecular antisera LDTs

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

Understanding the Transitional Timelines

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

Conclusion

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

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

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

Next steps to consider and how we can help

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

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

Posted on by

Navigating the Shift from IVDD to IVDR

Key considerations for lateral flow providers; is it time to outsource your legal manufacturer requirements?

In this regulatory blog Abingdon’s Head of Quality Assurance & Regulatory Affairs Candice Vendetuolli outlines the transition from IVDD to IVDR for lateral flow tests and its implications for manufacturers. One key consideration is whether to use a manufacturing company such as Abingdon Health with an established quality management system operating under IVDR.

Abingdon Health’s team has over 20 years experience in the lateral flow market and is a knowledge leader in the scale-up, transfer, manufacturing and regulatory approval of lateral flow products across a range of sectors including clinical (self-test, point of care), animal health, plant pathogen and environmental testing.

Introduction:

The In Vitro Diagnostic Device Regulation (IVDR) has ushered in a new era for the regulation of diagnostic products, impacting lateral flow tests significantly. As the industry adapts to these changes, outsourcing legal manufacturing to contract service providers with a compliant Quality Management System (QMS) under IVDR is becoming a strategic move for many companies and can remove a major headache.

Transition from IVDD to IVDR

The shift from the In Vitro Diagnostic Directive (IVDD) to the In Vitro Diagnostic Regulation (IVDR) marks a paradigm change in the regulatory landscape. IVDR, implemented in 2017, aims to enhance the safety and performance of in vitro diagnostic devices, including lateral flow tests. Manufacturers must adhere to more stringent requirements, covering clinical evidence, performance evaluation, and post-market surveillance.

The transition to the IVDR has caused significant challenges with infrastructure, Notified Body availability and manufacturing readiness resulting in the European Parliament voting to approve a further extension to the transition period. We took a deep dive in the impact of the extension in our blog last month on IVDR Transition Update which you can take a look at here.

Whilst the extension will be a relief for many, the requirements for manufacturers to prepare are extensive, and this should not be viewed as an opportunity to pause.

Impact on Lateral Flow Tests

Lateral flow tests, widely used for quick and simple diagnostics, face notable changes with the IVDR transition. The regulation demands comprehensive documentation, increased clinical evidence, and heightened scrutiny on post-market surveillance. Manufacturers need to invest in updated technologies and processes to comply with these stringent requirements.

Outsourcing Legal Manufacturing to Contract Service Providers

Amidst these changes, outsourcing legal manufacturing to contract service providers with established and compliant Quality Management Systems operating under IVDR has emerged as a strategic solution.

Providers such as Abingdon Health offer specialized expertise, infrastructure, and a streamlined process to navigate the complexities of the new regulatory framework. Abingdon Health’s Quality Management System operates under IVDR and therefore the addition of new products is a relatively straightforward process and can provide a more rapid and cost-effective transition to IVDR for lateral flow products.

Instead of having to replace your current IVDD compliant QMS with one that meets IVDR; or having to create a QMS of IVDR from scratch; you can tap into Abingdon’s existing QMS. Furthermore, given the requirements under IVDR are more onerous (e.g. post market-surveillance); outsourcing these activities to an experienced provider may make more sense; and be more cost-effective. Finally, if you are a company with one or a small number of products, it is very inefficient to run a QMS purely for this; with the fixed costs of running a QMS being significant.

Why Outsource Manufacturing under IVDR

  1. Expertise and Experience:

Contract service providers bring a wealth of experience and expertise in navigating the intricacies of IVDR. Their teams are well-versed in the regulatory landscape, ensuring compliance and reducing the risk of errors. Abingdon’s team has experience of working with notified bodies and managing the regulatory process on your behalf.

  1. Efficiency and Speed:

Outsourcing manufacturing to a specialized provider accelerates the production process. These providers are equipped with advanced technologies and efficient workflows, enabling quicker turnaround times for lateral flow tests. Abingdon’s Quality Management System is already established under IVDR; and therefore, it’s much quicker to use Abingdon rather than establish a brand-new quality management system for one product for example.

  1. Cost-Effectiveness:

Leveraging a contract service provider can be cost-effective compared to establishing in-house capabilities compliant with IVDR. Companies can allocate resources more efficiently, focusing on core competencies while relying on the expertise of external partners such as Abingdon.

  1. Risk Mitigation:

With IVDR introducing stricter regulatory requirements, outsourcing to a reputable service provider mitigates risks associated with compliance. These providers invest in continuous training and updates to ensure adherence to the latest regulations. For example, the post-market surveillance obligations under IVDR are significant and Abingdon Health has these processes established. This gives Abingdon’s customer peace of mind that these ongoing obligations are being dealt with.

  1. Flexibility and Scalability:

Contract manufacturing offers flexibility and scalability, crucial in the dynamic landscape of diagnostic devices. Companies can adjust production volumes based on market demands without the constraints of maintaining fixed in-house capacities.

  1. Access to Advanced Technologies:

Contract service providers often invest in cutting-edge technologies and state-of-the-art facilities. Outsourcing allows companies to benefit from these advancements without the upfront costs associated with acquiring and maintaining such resources.

  1. Regulatory Intelligence

The Abingdon Health group are ideally placed within the IVD industry to scan the horizon to monitor and adapt to updates ad changes to the European regulatory landscape, to ensure that our regulatory and quality system are state of the art and compliant to international standards.

Examples of IVDR transition and why outsourcing makes sense.

One example of why IVDR transition makes sense is for growth companies developing a new lateral flow test. Tapping into Abingdon Health’s established Quality Management System will save significant time and money and speed up the time to market and revenues.

A second example is an established diagnostics company selling a range of products that are CE-marked under IVDD. The Quality Management System is set up to manage all products and therefore if certain products are being prioritised for transition under IVDR, for example if they are Class D (high risk) tests then it may make sense to outsource the transition of these products to a contract service provider such as Abingdon Health. This keeps the process separate and “clean” and also means that you can leverage off Abingdon’s established Quality Management System.

Post Market-Surveillance

Post-Market Surveillance (PMS) is worth setting out in more detail. It is a critical change to the approach under IVDR and requires a lot more consideration, and resource. Abingdon Health has established processes to manage this process effectively on behalf of its customers.

The key requirements of post-market surveillance for Class A and B products are to summarise the results and conclusions of the analyses of the post market surveillance gathered, together with a rationale and description of any preventative and corrective actions taken.

In addition, for Class C and D devices other requirements include the conclusion of the benefit-risk determination, the main findings of the PMPF and the volume of sales and estimate of the size and demographics of the users. This information needs to be updated per product annually.

The PMS documentation requirements are significant: PMS System (all products), PMS Plan (all products), PMS Report (Class A and B products), PSUR reports (Class C and D products), SSP reports (Class C and D products) and if required for any class of products: Vigilance Reports, Trend Reports and FSCA reports. It is critical that this information is kept up to date as this information can be reviewed during your annual audits or unannounced audits and also will be reviewed at least once every 5 years as part as product re-certification.

Key Takeaways

The transition from IVDD to IVDR brings both challenges and opportunities for manufacturers of lateral flow tests. Outsourcing legal manufacturing to contract service providers operating under IVDR offers a strategic avenue for companies to adapt to the evolving regulatory landscape efficiently. By tapping into external expertise, leveraging advanced technologies, and ensuring compliance, businesses can navigate the complexities of IVDR while maintaining a focus on innovation and market competitiveness.

Decades of experience in taking tests from concept to commercialisation has led to Abingdon Health establishing effective processes to minimise risk and maximise the chances of commercial success. Abingdon’s regulatory team has experience on managing the IVDR transition process and ongoing obligations and can support your inhouse team or provide a fully outsourced regulatory solution to ensure you are well-prepared for your IVDR transition.

If you would like to understand more about the regulatory process, including FDA, CE-marking and UKCA-marking and discuss any specific requirements or concerns, contact a member of the IVDeology team by clicking here

Or if you’d prefer an easy and on-the-go accessible app right on your handheld device such as phone or tablet, you can download our IVDeology app which has the current IVDR specification handbook and for quick access to support from IVDeology – available for Android and Apple Store FREE download

Posted on by

IVDeology Partners with MedBoard

Cutting through the Regulatory Noise: Our new partnership with MedBoard

It seems that the medical device regulatory world has gone into overdrive in the last few years. The rate of regulatory change and the demand for clear guidance around them has substantially increased, especially when you focus on the European Union and the UK which are th key areas IVDeology specialise in. It is now getting to the point where one regultory expert simply cannot know everything they need to know, and this is without the peripheral requirements of REACH, CLP, Sustainability, Environmental and Digital. The need to find the right information from a trusted source has never been so important, as well as in a timely manner.

Our Regs Consultant Fiona Thompson commented the following:


“When I left my previous role to start at IVDeology, finding relevant, correct regulatory updates was one of the things I found most challenging. Having come from a large company, this was all done at a Corporate level and at our site we found out information from notifications or changes to the Global procedures sent out. Out of this corporate world, the places I knew where to look for information had all disappeared and trying to find all the potential websites to set up personnel alerts, I will be honest, was very painful – and I’m still sure I haven’t found them all.”

Even from the early days of IVDeology, the aim was to develop a strong team connected to a wide and diverse industry network, which would help us inform our customers on any Quality and Regulatory updates relating to IVDs and Medical Devices. We do this knowing that many of our SME customer don’t have this network themselves and getting the right information can be a very difficult and time-consuming thing.


Recently we have started using a system called MedBoard – and what a game-changer this is!


“MedBoard is a dedicated search engine for the sector. You can set up customised reviews with relevant key words to keep up to date with new regulatory news in specific countries that you are interested in as well as conduct searches for PMS, literature searches etc. It also sends you email alerts when new information is released. What MedBoard does is provide you with a starting point for regulatory intelligence, based on trusted resources, this allows you the opportunity to build your understanding and supplement your existing knowledge network.”

How do we use MedBoard to support our customers?


IVDeology have used the MedBoard subscription services since early 2023 as we personally find the subscription beneficial to cut through the noise and share the industry updates that are tailored and beneficial to our customers.
IVDeology is proud to funnel information down to our customers and recommend MedBoard’s services and be able to add:

a) timely regualatory updates from a trusted source
b) offer insights on the impact of these updates, using our in-depth knowledge of the IVD indsutry

The outcome for this is to give you the ability to make informed decisions, develop strategies and mitigate changes to the IVD industry relevant to your devices and markets.

At IVDeology, we don’t believe these is a one size fits all model for what we do, as we are committed to helping you in the way that works best.

We’re happy to be able to share updates from MedBoard and put you in touch if you wish to sign up individually as a company to be able to personalise the package at which level you wish, as MedBoard offer several layers of package support depending on budget and need including a new artificial intelligence scanning tool as well as software Validation documents approach for QMS/GxPs processes overviews.

IVDeology adds a layer of support to help explain and discuss the updates and how this may affect your company, teams and projects. This sits well alongside our existing compliance services including UK Responsible Person (UKRP), Person Responsible for Regulatory compliance (PRRC), training, ad-hoc and project support. You can find more about these services on our website.


And to support one step further, IVDeology have a certified team of Quality experts in ISO9001 and ISO13485 to help with implementation of QMS systems and remediation, including software validation.


We don’t make anything from sign ups, we just really think the tool is an excellent creation, and side by side we can create a support system of clear updates whilst also breaking it down into easy digestible actions which saves you valuable time.

For further information or a demonstration on how we can help you, please book a call with Casey or drop us an email at [email protected] to know more.