Tag: Quality assurance

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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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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

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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.