Tag: QMS

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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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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

 

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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

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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

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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.