Author: Stuart Angell

IVDeology Pioneers Productivity-boosting Mental Health & Wellbeing Programme with Thrivall to Win Platinum Healthy Workplace Award

Medway-based company IVDeology, is excited to announce a recent partnership with proactive workplace mental health and wellbeing programme Thrivall.

Founded in 2018, IVDeology is a growing team of like-minded, friendly professionals who are passionate about regulatory affairs within the in vitro diagnostic medical device industry. The company brings a flexible and pragmatic approach to support other businesses in navigating IVD quality and compliance requirements.

Working from offices in the Chatham Historic Dockyard, IVDeology is focussed on ensuring flexibility, personal development and gender equality within the team. Co-founders and directors Stuart Angell and Nancy Consterdine share a belief that supporting staff and helping them grow will create benefits for both their own business, and also for customers. 

Thrivall Managing Director and Co-founder Anwen Cooper commented: “We are delighted that IVDeology have chosen to pioneer the Thrivall programme with their team. Our structured and sustained approach is designed to provide outstanding levels of colleague care to support everyone in the business to realise their full potential while also delivering increased productivity and boost bottom-line results for the business.” 

Dan Corpe, Thrivall Partnerships Director and Co-founder adds: “The Thrivall programme focuses on bettering the individual for the betterment of the organisation. IVDeology is a great example of a forward-thinking, people-focussed business which has embraced the Thrivall ethos as they fully understand the benefit of investing in their team.”

Thrivall brings together qualified and experienced experts to deliver a uniquely structured solution to workplace wellbeing and mental health. Combining an evidence-based and comprehensive programme, Thrivall delivers team training workshops on all aspects of wellbeing, along with regular proactive counselling and professional performance coaching sessions for every individual within an organisation. In addition, impact is measured through regular benchmarking evaluations to track progress and demonstrate return on investment. 

IVDeology Managing Director Stuart Angell said: “Thrivall has fundamentally changed how our business feels. The team build effect is palpable. Two colleagues have approached me separately to say how the programme is going to change their lives for the better. We really appreciate how Thrivall has given us all a shared language around mental health.”

Nancy Consterdine, Director of Training and Compliance at IVDeology added: “We are delighted that our commitment has been recognised by the Medway Healthy Workplace Awards Programme. We have progressed over the last few years from Bronze, through Silver and Gold and have now been given the Platinum Award. This is the highest-level recognition of the continued investment we’ve made to date in the wellbeing of our team.”

Notes to editors:

More info about IVDeology: www.ivdeology.co.uk¦More info about Thrivall: www.thrivall.co.ukEmail [email protected] and [email protected] for further 

In the recent budget announcement from Jeremy Hunt , it referenced the intension to enable the MHRA to sign-off medicines and technology already approved by trusted regulators from 2024. There is already Project Orbis – GOV.UK (www.gov.uk) which provides a framework for concurrent submission and review of oncology products among international partners. This is co-ordinated by the U.S. Food and Drug administration alongside MHRA and involves the regulatory authorities of:

• Australia (Therapeutic Goods Administration (TGA))
• Canada (Health Canada)
• Singapore (Health Sciences Authority (HSA))
• Switzerland (Swissmedic)
• Brazil (Agência Nacional de Vigilância Sanitária (ANVISA))

Additionally MHRA together with the regulatory authorities of Australia, Canada, Singapore and Switzerland is part of the Access Consortium Access Consortium – GOV.UK (www.gov.uk) which is a medium-sized coalition of regulatory authorities that work together to promote greater regulatory collaboration and alignment of regulatory requirements.

What might this have to do with Medical Devices?! I can hear you asking, neither of the groups above currently mention them. However, these could be seen to be setting the precedent, the closer ties that the UK government is building with the USA, Canada, Australia would immediately seem to be the most logical states to be considering when talking about approvals from trusted regulators. Additionally, with the MHRA official delay of the new UK Medical Device regulation out to June 2025 it gives IVD Device manufacturers to possible opportunity to look at a two pronged regulatory strategy for launch. 

It may be wise for manufacturers looking to bring new devices to the market in the next couple of years to seriously consider forgoing the EU as the first port of call for registration approvals. The US FDA 510K/PMA process is a clear, well understood process which does stick to timelines unless real issues are identified during the review. The pre-submission process is a way for a manufacturer to gauge how the FDA is viewing the device and feedback, whilst not direct advice, allows adjustment before final submission. This allows the manufacturer to have the best opportunity for approval with as little too and fro as possible. For manufacturers who have an innovative device, the Breakthrough Device Designation programme may be to route to take Breakthrough Devices Program ¦ FDA. 

By looking to bring devices to the UK market through the current UK MDR 2002 which is based around the IVD Directive requirements, allowing many manufacturers to self-certify, and simultaneously submit to the US FDA, two recognised regulatory approvals could be delivered within 6 months of file submission. EU IVD Regulatory approval should not be dismissed but for start-up organisations, where revenue is key, this approach would result in getting to market sooner and being more attractive for acquisition if that was an attractive proposition. 

If you are interested in learning more around UK MDR support and or US FDA requirements please get in touch [email protected] or book a slot in my calendar

Back in 2018 when Nancy and Stuart had founded IVDeology, I was working as a lab technician in IVD manufacturing, where I had been for 14 years. In May 2019 I took the step to join Nancy and Stuart to help build and grow IVDeology. It was a no brainer as I knew there would be so many opportunities to learn and grow with the company and make a difference in the world of diagnostics.

At the start we knew we wanted to setup a QMS. We were all from lab environments so had lived and breathed in the ISO 13485 world. We knew by having a certified QMS it would help define and control our processes and give our clients confidence in our commitment to customer satisfaction and continuous improvement. For our business we decided ISO 9001:2015 was the most appropriate standard for our needs. 

My role as Operations and Quality systems Co-ordinator was to setup up and maintain our QMS. This was a great challenge as I had only ever worked within a QMS and had not been involved in the day to day running or setting up of one.

We tried using our current Microsoft system, but we really struggled with some of the document control features we wanted, and it just seemed to be really clunky. 

Then one of our customers introduced us to Cognidox. Cognidox is an electronic document management system but also so much more. After the demo we realised it ticked all the boxes we required from an EQMS. 

So we signed up for a trial and got to work creating the documents we needed for our company and to be compliant to ISO 9001:2015.

We created all the procedures, policies and forms and got through our stage 1 audit and once we were fully using the system got through stage 2 to gain certification in Jan 2021. 

That was a huge achievement and milestone for the team and I.

I am even more proud of this achievement as you may remember January 2021 we went into lockdown a second lockdown, and we had another period of home-schooling our then 5-year-old. Let’s just say this was a tough time, but I feel I came out of it stronger, and with more confidence to face future challenges. 

Though it wasn’t the end of the story of course, as with all QMS’s we are continually reviewing, updating, and improving our documents to evolve with the company. 

We lived with the documents and started to learn what worked and didn’t work for us within the scope of the standard. 

As a result, our documents are now much more streamlined as we’ve gone for a simplified process flow approach, as we’ve found these to be much more effective for our company. Cognidox were there to listen to our queries, our wants and needs, and make it work for us. It wasn’t a one size fits all which some EQMS can be.

We have a really robust process for CAPA, change control and staff training. It’s tailored to fit our quality and operational needs.

We have got through 2 successful surveillance audits, and we look forward to our recertification audit in December this year.

I have learned so much from this journey:

• oRealising the perfect procedure or document doesn’t exist, they should always be evolving, the simpler the better and always designed with the user in mind. 
• oDon’t over complicate things, as you can end up getting tied up in knots. 
• oAn electronic document management system is so important for document control, training, and report functions (making management so much easier). 
• oIt is a huge challenge, but with the right support ,hard work and knowledge it results in a huge achievement. 

Our team all have years of experience not only building quality management systems but living in them too, this helps us to understand the requirements for the people using the system to guarantee it works for the individual company.

If you require any Quality management system support or advice please get in touch, our highly experienced team are ready to help. 

We also partner with Cognidox, so if you feel you want to go from paper based to EQMS, please reach out and we can put you in touch with the team. 

The MHRA have announced a delay to the introduction of the future regulations in the UK. The updated guidance now states that the aim is for the new regulations to apply from 1 July 2025 – a further one year delay to what had already been announced.

The acceptance for CE marked medical devices on the GB market will also be extended from the current date of 30 June 2023. The intention is for the government to introduce legislation before this date to extend the date these devices will be accepted for up to 5 years for medical devices and IVDs CE marked under the EU MDR or EU IVDR respectively – bringing the date that these will be accepted to 30 June 2030. There will also be up to 3 years for medical devices CE marked under the MDD and up to 5 years for IVDs CE marked under the IVDD or until the expiry of the device certificate. Any devices that would be classified as Class I medical devices or Class A IVD’s must be CE marked under the EU MDR and EU IVDR respectively to be placed on the market during this transition period.

It is also confirmed that the additional post-market surveillance requirements will be introduced later in 2023 and are expected to apply from mid-2024.

Whilst this still needs to be approved by Parliament and there is still no clarification on the details of what the new future regulations will look like, this is welcome news to manufacturers.

For the full announcement see the link below: Implementation of the Future Regulations – GOV.UK (www.gov.uk)

If you have any questions or want any assistance, then please book a call with us.

The regulations in the IVD industry have been slow in catching up with the fast-moving software development space. This can often make it harder to understand what needs to be done to satisfy notified bodies and get a safe and effective SaMD (software as a medical device) on the market.

Good planning will reduce the overall cost of the project. It is worth spending a time clearly defining the problem before starting any design and development. Clearly understanding customer requirements is key to translating these requirements into software requirements and formulating your software requirements specifications.

Here’s a step-by-step guide of what needs to be done:

Step 1: Make sure you have determined a clear intended purpose for your device (thinking about how you expect your device to be used, in what environment and by who) as this will make it easier to classify your device. It is also important to check whether your device falls under the definition of SaMD. The MHRA have created a handy guidance document to work through this. Medical devices: software applications (apps) – GOV.UK (www.gov.uk)

Step 2: Use the international standards IEC 82304 and IEC 62304 which are integral to developing safe and effective medical device software. These have strong ties to ISO 13485 for Quality Management and ISO 14971 for Risk Management. 

IEC 82304: This standard deals with the general requirements for product safety for health software. The scope of this standard covers SaMD as well as health software not classified as SaMD but does not apply to health software which is part of specific hardware for health use. The standard covers the entire lifecycle including design, development, validation, installation, maintenance, and disposal of health software products and signposts you to IEC 62304 for the development activities.

IEC 62304: is a process standard covering the life-cycle processes that tell you what activities and tasks need to be performed to ensure you have a safe and effective medical device. It applies to both SaMD and software that is an embedded part of a medical device. Determining the safety risk classification indicates which parts of this standard are applicable to your device. Risk Management activities are performed throughout the development life cycle. 

ISO 62304 also covers architectural design which segregates the system into functional items/blocks with interfaces, followed by more detailed design of the units that make up these items. Coding only features at the implementation phase and involves unit verification. Integration and system testing then show how all the units of code come together to form the items and how the items are put together to form the system. Well planned and documented test procedures and acceptance criteria are key. 

Step 3: Usability testing: It is also important to apply usability testing principles by complying with IEC 62366-1 (Medical devices – Part 1: Application of usability engineering to medical devices). The useability engineering process is intended to identify and minimise use errors and thereby reduce use-associated risks.

Step 4: Releasing and maintaining your device: The job isn’t over once you have released your device and placed it on the market. ISO 62304 covers maintenance, configuration management and problem resolution processes including analysing feedback and version and change control post-market. Post market surveillance activities are also covered in ISO 82304.

This gives some information on what is required to get onto the market but navigating all these requirements is not easy.

But we can help. 

We have a positive, friendly, and flexible approach to helping you get your device on the market, this includes helping to navigate the complexities with SaMD at all stages of the Software Lifecycle 

If you want to know more, book a call with Casey for a friendly chat on how we can help.

Manufacturers (or their UK Responsible Person) placing devices on the UK market are required to report any adverse incidents relating to IVDs and Medical Devices to the Medicines and Healthcare products Regulatory Agency (MHRA). This notification step is a part of the wider Vigilance process that Manufacturers should adhere to as part of post market activity.

“The notification and evaluation of adverse incidents and field safety corrective actions (FSCA) involving medical devices is known as the medical device vigilance system. Comprehensive information on the medical device vigilance system is given in MEDDEV 2.12/1 rev 8 and the additional guidance under ‘Post-Market Surveillance’, and describes what, how and when to report adverse incidents involving medical devices on the UK market.”

Timescale for reporting an adverse incident to the MHRA

The manufacturer should notify the MHRA immediately upon becoming aware that one of its devices may have caused or contributed to an event meeting the above criteria.

The maximum permitted time between the manufacturer first becoming aware of the incident and notifying the MHRA are given below:

Serious public health threat: No later than 2 calendar days after the manufacturer becomes aware

Death or unanticipated serious deterioration in state of health: No later than 10 calendar days after the manufacturer becomes aware

Others: No later than 30 calendar days after the manufacturer became aware

If after becoming aware of a potentially reportable incident it is unclear whether the event meets the reporting criteria above, the manufacturer must submit a report within the relevant timeframe.

Source: Medical devices: guidance for manufacturers on vigilance – GOV.UK (www.gov.uk)

Reporting is to be completed in the new MORE portal. The old portal will only be available as read only up to 30 April 2023. Manufacturers can also send any reports to the [email protected] mailbox. This option was due to close at the end of April 2023, but this route has been extended to August 2023. After this, the use of the new MORE portal will be mandatory.

This deadline has recently been extended, to allow manufacturers to get familiar with the new portal, and maybe to iron out some teething issues reported by users.

There are some new handy video clips on how to use this process within the MHRA website.

If you need any further advice or support for the completion of vigilance actions, IVDeology have a number of experts who can guide you through the process.

If you are a non-UK based IVD manufacturer, we would be keen to have a chat to see how we can help you navigate the UK regulations.

For a lot of manufacturers Risk Management is one of those tasks seen to provide little to no value and is simply a regulatory tick box exercise. That Risk Management File drafted during Design and Development, may have had the odd update here and there over the years, but on the whole, its been neglected. 

With the introduction of the EU IVD Regulation 2017/746 comes a greater emphasis on establishing a system for Risk Management and its regular update, in line with post market surveillance. But for some organisations the idea of dusting off those Risk Management Files and bringing them inline with the current expectations of ISO 14971:2019 and the IVDR, fills them with dread. Finding the resource and the time required to breathe new life into the old files may be tricky and often people lack confidence in their Risk Management knowledge, which can paralyse the process.

The good news is Risk Management doesn’t have to be painful and if your product has been on market for a while you have a wealth of knowledge to guide you in your estimation of the risks.

My favourite (sad I know) industry standard; ISO 14971:2019 – Application of risk management to medical devices, clearly explains the steps in the process and its handy guidance ISO/TR 24971:2020, expands upon each step providing examples to aid our understanding and guides the readers through the complexities of process. Each time I read through the guidance I take additional learning away with me. Annex H in particular is a must read for anyone leading risk management for IVDs, it includes specific examples for the unique considerations applicable to IVDs. 

So where do you start? My recommendation would be to take a look at your existing procedure and the templates you use to create your Risk Management File (RMF) documents. Are they aligned to current requirements? If not start by creating a procedure that fits the expectations of ISO 14971:2019, ensure it links to your post market surveillance procedure and the other key QMS processes such a complaints, non-conformance/CAPA and change control which can have impact on the RMF. Next assess whether your templates cover all the required aspects, for example do you have a benefit-risk analysis? 

Once you have the procedure and templates where you need them, I would recommend reviewing a sample of your existing files, assess if they could easily be updated to the new requirements? Or would it be better to start fresh and incorporate the information within the existing files, into your shiny new templates? 

Now comes the sometimes challenging part, what resource do you have available to lead the updates and who can be in the team? Risk Management is most successful when someone has ownership but can pull together a broad cross functional team to assess the product from all angles. Gone is the requirement to have qualified staff involved in risk management, replaced with the need for those competent on the basis of education, training, skills and experience related to the tasks assigned to them. This provides the flexibility to include and draw upon the knowledge of those most hands on with the manufacture and testing of the product, to share their valuable insight. For IVDs estimation of risks to patient can be challenging. Many IVDs have professional users and clinicians interpreting results and determining the next steps for the patient, making the potential harm to patient more indirect. Inclusion of a clinical expert within your Risk Management team is an invaluable resource that can guide the team through the sequence of clinical events leading to hazardous situations and the resulting patient harm. Growing everyone’s understanding of the device and helping the team to see it from the other side. 

In summary risk management can be a challenging undertaking but when approached in the right way it can build device knowledge internally, and deepen understanding of the user and patient experience, which can stimulate continuous improvement in device design, usability and safety.

At IVDeology we can help support your risk management journey through providing;

• Training
• Procedure and file templates
• Direct support for the risk management lead/team
• Review of files and recommendations for enhancements
• Targeted workshops with the team to focus on specific topics 

To discuss how IVDeology can help support you, please book a call here.

One  of the most common conversations I have, stems from the question, “When do you need to start thinking about Quality or Regulatory support?” The majority of the cases, this conversation happens too late in the design and development process, this causes major headaches for manufacturers who have to quickly backfill their regulatory or quality processes to catch up with product design and development.

Whilst I agree that having a permanent QA/RA presence within an SME, especially at the early stages of growth and a costly move, there are significant advantages to having a strong regulatory understanding  as early as possible:

• Gain an understanding of your device classification based on intended purpose
• Explore bast practises by utilisation and application of international standards
• Build forward facing technical and documents and performance data suitable for market submission
• Early consideration to risk assessment, mitigation and risk benefit
• Establishing strong mechanisms for design and development, and supplier management

So what do you need when? Here is are some considerations at each stages

Concept Stage

As early as possible, build your quality plan and regulatory strategy documents. These can help you define which direction you are heading, and what you need to achieve to get your devices on market. A good understanding of the applicable regulations are key here, and don’t forget international standards too.

Have a look at similar devices on the market and get an idea on the Intended Purpose of your device: how are you intended your device to be used, in what environment and by who? Once you know your intended purpose, you can then get a sense of what possible risks are associated with using the device, or when there is a wrong result. This will help you define the control mechanisms for designing your device.

Design & Development

So you have an idea, now it is all a question of design and development to make your ideas a reality. The medical device industry utilises a series of quality processes to ensure that you design or device as safely, and effectively as possible – within a Quality Management System. This is defined within the international standard ISO13485, or ISO15189 if you are in a medical laboratory environment.

Establishing robust controls takes time, but the benefits are enormous, especially later in the process when the device needs to meet the regulatory requirements, which includes having a quality management system. While you can obtain templates and electronic systems, Quality Management Systems are not one-size fit all, to be truly effective (and not overly burdensome) it is well worth investing time to really consider how you can embed the right controls for your device and organisation.

Manufacture

The manufacturing stage should be building on all the great work that you have put in during the previous stages. Validation and verification against your plans and risk assessments is key here. A strong QMS will help you standardise your process using a risk-based approach. During this stage, you should be compiling the technical, quality and performance documentation that you have been collecting, ready for submission. 

Effective supplier control, change control and non-conformance reporting is critical in this stage, all this should feed your Quality Management System, where the data provided should make your design and manufacturing processes stronger.

The extent and nature of the documents and processes you need will depend on your organisation and device.

On Market

You are ready to release your device on market, the finish line is just up ahead. If you have considered the quality and regulatory requirements throughout the journey, then you should be in good shape. But don’t underestimate the investment of time and money needed to place devices on market. Submissions can take up to 24 months depending on market and conformity routes. 

Once you finally get market approval, the fun doesn’t stop there, continuous quality and regulatory surveillance is required to ensure that your device is safe, effective and continued to meet the state of the art. 

So hopefully the above gives you some ideas as to when businesses need to think about quality and regulatory. At IVDeology, we work with manufacturers of all sizes, from the very beginnings to the post market phase. Our mission is to help them at each stage of their journey to try to help understanding in a positive way, the complexities and nuances of IVD regulation. If you want to know more, book a call with Casey.

It can be a little daunting when you need to hire specialists for a project, either short or long term, permanent or contract.

IVDeology are here to be able to parachute into projects with the knowledge and background to slot right into a company, add their value and expertise, and leave you in a better position, whether that be working on non-conformances from an audit, or simply helping you get to your QMS implemented, to taking you fully from manufacturing a product to getting it onto the market, successfully, safely, and of course compliant. 

There are two ways you are able to reach out and engage with IVDeology;

1. Directly. This is where we get most of our business, from customers and our network knowing of us individually or as a team, from our social media, Linked in or from website searches and ads. 

2. Via an agency – recruiters will have customers who have a requirement for one or several specialists within their company and pay good money for them to put the time and energy into resourcing options. Requirements would from the client via the agency, to IVDeology

Benefits of direct

– Your budget can go more towards the specialist and the project, rather than a percentage towards the agency for finders fees or their services

– We can offer you a package deal on a deliverables or on an hourly basis, from pay as you go services, to background Quality and regulatory support 

– You may have a need for several specialists in different areas, which means needing to speak to several different agents and contractors, set up interviews, and align timings and budgets which can be variable depending on points such as location, on site work, and level of skill, as well as what the individual wants to charge which can range, whereas at IVDeology you can get a bespoke team of people for one price, under one roof and via one company. You wouldn’t have to worry about paying an agency to then pay your contractor, or work towards an agencies additional fees or work towards their standard terms of payment and invoicing etc

How does it work?

– You’d reach out to us via a specialist you may already know, but most likely via email, our ‘contact us’ page on our site, or LinkedIn

– You would meet the specialists on a kick off meeting after our Customer success specialist finds out your project needs 

– Payment would be invoiced and paid directly to the client from IVDeology 

– We would send you a project breakdown and quote, how to invoice, and we would work with you on a bespoke offering of support

Benefits of agency

– We have good relationships with agencies we trust, and they can work out the details on your behalf, and save you time if your role within the company isn’t necessarily hiring, and you have responsibilities elsewhere within the company

– They can focus on the admin such as CV sending, amendments, cover sheets if applicable with summaries of skill set and set up interviews which sometimes can be multiple 

– You have an agent who knows the market, be able to let you know whose available on the market to monitor projects 

How does it work?

– You would receive a CV from a specialist from IVDeology via your recruitment agent depending on the specification, you would be able to meet and speak to the specialist(s) who would support you working under IVDeology 

– The agent would set up the interviews and send across IVDeology company details for insurance, terms etc. 

Both ways work well for us, and it’s really how well it works for you as a company. We hope that the above helps you with the way you request our services, and that we will happily work with agencies who feel we can provide a specialist to support their project.

Written by Customer Support Specialist Casey Sedgwick – ex recruiter

Written by Regulatory IVD consultants TszWai Woo and Fiona Thompson of IVDeology Ltd 

---

16th February 2023 saw the EU Parliament has voted in favour of the European Commission’s proposed MDR/IVDR amendment. Finally, an update!

The main impact for the IVDR is that the ‘sell-off’ period for existing IVDD products, previously specified in IVDR Article 110(4), has been removed. This means that IVDD devices already legally placed on the market can continue to be made available beyond 27 May 2025. This also applies to the MDR Article 120(4).

In addition, for the MDR, the transition period has been extended to end of 2026/2027/2028, subject to certain conditions and depending on the risk classification of the device. This means that the validity of MDD certificates can be extended, providing a formal application for an MDR conformity assessment has been submitted to a notified body by 26 May 2024, with a notified body contractual agreement by 26 September 2024.

The proposed amendment still needs to be adopted by the European Commission and published in the Official Journal, when this amendment will then enter into force.

This is welcoming news for the medical device industry as it will allow continued supply of safe devices on the market. 

This opportunity is going to benefit manufacturers who have already started actively taking steps towards achieving MDR/IVDR compliance and eyes should not be taken off the ball…

Written by Regulatory IVD consultants TszWai Woo and Fiona Thompson of IVDeology Ltd