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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

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EUDAMED: A recap for what it means for you

IVDeology are a UK based regulatory and quality compliance support company, with over 100 years combined of expertise within our team, providing you everything you need for your in-vitro diagnostic device life cycle to support you on your compliance journey. In this most recent blog written by Regulatory specialist TszWai Woo takes a look at what EUDAMED is, and what the changes mean to you.

The Medical Devices Regulation (Regulation (EU) 2017/745, ‘MDR’) and the In Vitro Diagnostic Medical Devices Regulation (Regulation (EU) 2017/746, ‘IVDR’) introduced the requirement of EUDAMED, the European database on medical devices. It has been over 3 and 2 years, respectively, since the date of application of the MDR and IVDR, and even after several transition extensions and amendments to both regulations, EUDAMED is still a way off from being fully functional.

With another proposed Regulation (2024/0021 (COD)) due to be published in the Official Journal of the European Union, it is worth having a recap on what EUDAMED is, the current status and what changes the new regulation will introduce.

What is EUDAMED?

EUDAMED is a European database on medical devices that the European Commission was to set up, maintain and manage, as required by the MDR and IVDR. The aim of EUDAMED is to improve transparency and provide information on medical devices on the EU market to the public and healthcare professionals. It also aims to improve medical device traceability, enhance coordination between the EU National Competent Authorities and provide them with easy access to relevant regulatory information.

EUDAMED contains information on medical devices which are organised into the following 6 categories, also known as modules:

  • Actor registration
  • UDI/Devices registration
  • Notified Bodies and Certificates (except for the mechanism for scrutiny and the clinical evaluation consultation procedure (CECP) functionalities)
  • Clinical Investigations and Performance Studies
  • Vigilance and post-market surveillance
  • Market Surveillance

A lot of the information within EUDAMED is to be accessible to the public via a public website.

Current State of Play

To date, only the following 3 modules have been available for voluntary use:

  • Actor registration (since December 2020)
  • UDI/Devices registration (since Oct 2021)
  • Notified Bodies and Certificates (since Oct 2021)

Therefore, manufacturers can submit their organisation and device details on a voluntary basis.

For Actor registration, as well as providing the organisation details, all manufacturers will need to provide a declaration on information security responsibilities and non-EU manufacturers will also need to provide a mandate summary document.

For UDI/Device registration, manufacturer will need to submit device information such as the Basic UDI-DI & UDI-DI, the European Medical Device Nomenclature (EMDN) and notified body (NB) certificate information (if applicable). For devices requiring NB conformity assessment, the NB must confirm the device information in EUDAMED before the device can be publicly available. Therefore, conformity assessment must be completed before prior to registering a device in EUDAMED.

NBs can register certificates and Summaries of Safety and Clinical Performance (SSCP) on voluntary basis. However, there is a caveat: all the parties referenced in the certificates must first be registered, also on a voluntary basis, in EUDAMED.

Additionally, the ‘Vigilance and post-market surveillance’ and ‘Market Surveillance’ modules are due to be made available Q2/2024 and the ‘Clinical Investigations and Performance Studies’ module is not due to be made available before Q3/2026.

EUDAMED was intended to be mandatory for all economic operators to use, after all 6 modules were declared fully functional following an independent audit and a Commission notice was published in the Official Journal of the European Union.

Proposed changes to EUDAMED requirements

Instead of waiting for the completion of the 6th module to make the use of EUDAMED mandatory, 2024/0021 (COD) proposes a gradual roll-out of the mandatory use of each EUDAMED module, once they have been audited and declared functional.

This means that the mandatory use of 3 modules (Actor registration, UDI/Device registration and Notified Bodies & certificates) could therefore start in Q4/2025.

Given the requirements of Article 123 (3) (d) MDR/113 (3) (f) IVDR and Article 123 (3) (e) MDR/113 (3) (a) IVDR, this would mean that mandatory use of all six modules cannot be expected before Q4/2027 and final transitional periods will not end before Q2/2029.

Final Thoughts

Whilst the medical device industry waits with bated breath for the proposed regulation to be published in the Official Journal of the European Union, it is advisable that manufacturers ensure they understand and have all the information they need for the EUDAMED Actor and UDI/Devices registration processes. Hopefully, the proposal will encourage more manufacturers to register on a voluntary basis, as delays in the module development have resulted in low adoption of EUDAMED.

As a UK provider of quality and regulatory services, IVDeology are proud to engage with the IVD industry and keen to support IVD manufacturers with IVD devices market access. For further information on how we can help, please contact [email protected] or you can book straight into our calendar here

Note: This blog contains a summary of the key changes within the proposal, it is important that Manufacturers read and understand the proposal in full, and get independent legal advice if required.