Tag: ISO13485

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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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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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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

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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