Author: Stuart Angell

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 

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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 

The published consultation on the future regulation of medical devices in the United Kingdom by the MHRA allowed the diagnostic industry a first look at the intensions for the innovative device access pathway (IDAP), where the MHRA focused on the opportunity to be “at the forefront of medical device innovation”, thus allowing manufacturers to launch their new and novel devices onto the UK market.

The desire for the UK to be the primary market access for the new device is ambitious and well received, the mechanism for this to happen is still unknown. 

The National Institute for Health and Care Excellence (NICE) have provided a little more context on this process in their summary:

“The Innovative Devices Access Pathway (IDAP) is a joint project between NICE and:

• the Medicines and Healthcare products Regulatory Agency (MHRA)
• Health Technology Wales
• the Scottish Health Technologies Group.

Our involvement in the pilot phase of the project is funded by NHSX.

It will research, design and scope an innovative access pathway for selected medical and digital health technologies that:

• are new and innovative
• meet critical unmet needs in the health and care system
• have the support of an NHS organisation or network
• meet relevant safety standards.

The pathway will be piloted with digital health technologies. The aim is to help manufacturers provide their devices to healthcare professionals and patients at the earliest safe opportunity.

The pathway will help developers generate evidence that meets the needs of the regulator and health technology assessment bodies. It will also offer post market access support.”

In order for the UK market to achieve its aim in ensuring continued patient and public safety by establishing a world-leading regulatory ecosystem, the IDAP initiative is a welcomed and exciting prospect for the UK market. 

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IVDeology are supportive members of the British IVD Association (BIVDA), and Stuart is the current Chair of the Regulatory Affairs Working Party, who have been working with the MHRA on establishing a roadmap for IVDs in the UK. For any information on the UKCA process, or the BIVDA Reg Affairs working party, book a call with Stuart via [email protected]

Today, IVDeology attended a workshop by the MHRA on the implementation of UKCA, the aim of this webinar was to update the industry on the upcoming changes to the Medical Device Regulations (MDR2002). The MHRA have always been seen to engage with the industry to create a proportionate regulatory framework which aligns to international best practise ensuring patient safety and continued market access.

The new regulation was expected to be put in place in July 2023, with a 5 year transition. This date has now been delayed by 12 months to July 2024. 

IVD Transitional Arrangements

UKCA Marked under UK Regulations	5 years, or expiry of certification
CE marked under EU IVDD	As above
CE marked under EU IVDR	Up to 5 years

During the period of prolonged turbulence in the IVD industry, which the transition to EU IVDR in full flight, I think what we need now is a degree of visability and forward planning to make sure we know how to place new and legacy devices on the UK (and EU) market. July 2024, all of a sudden, doesn’t seem that far away.

While I fully understand that creating a new regulatory framework is a large and complex body of work, it is imperative that we know and understand what we need to do to design, develop and update our IVDs and Quality Systems in readiness for the UK market. As a UKRP provider, we need to relay such information back to our non-UK customers as early as possible. Sadly, at the present time, we remain in a slight holding pattern waiting to receive the new draft of the new regulation.

What we are expecting is a Statutory Instrument on transitional arrangements in the next few months, following by further updates on PMS requirements before the MDR draft text later this year. 

Whilst the timelines are not ideal, it is important not to wait. While we are circling, what we can do is to focus on improving our internal processes and documentation to the state of the art in relation to the IMDRF frameworks. If you are focusing on the EU, make sure you are progressing with the EU IVDR… The UKCA process will be similar and nature and extent as both IMDRF and EU IVDR, so it makes sense to focus on these key elements, in doing so, this will give you as best a chance to be ready for UKCA when it comes.

If you would like further information on the UKCA, or UKRP please contact [email protected], to setup a call with Stuart.

According to the current UK MDR 2002, an in vitro diagnostic medical device is

‘a medical device which

a) is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system, whether used alone or in combination; and 

b) is intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information: 

i. concerning a physiological or pathological state 

ii. concerning a congenital abnormality 

iii. to determine the safety and compatibility of donations, including blood and tissue donations, with potential recipients, or 

iv. to monitor therapeutic measures and includes a specimen receptacle but not a product for general laboratory use, unless that product, in view of its characteristics, is specifically intended by its manufacturer to be used for in vitro diagnostic examination.’ 

Understand the devices Intended Purpose

The key question to start is: Does the output from the test have a medical purpose? This question differentiates the device from other non-medical tests, for example: tests used to check if you are driving while under the influence of drugs or alcohol, or what percentage of your genetic heritage comes from Iceland.

Specimen receptacles, intended for the containment and perseveration of specimens derived from the human body for the purposes of medical examination are also considered an IVD.

Some software including mobile apps, offer many different elements of testing, some parts of that application may have a medical objective, some may not. SO it is really important to understand which parts of the software come under the scope of the MDR2002. For more information on this, refer to the MHRA guidance on Medical devices: software applications (apps) – GOV.UK (www.gov.uk)

If the purpose of the device is not intended by the manufacturer to be an IVD device, then this could fall into ‘General Laboratory Use’ and would therefore sit outside of the MDR2002. However the limitations of the use of the device should be clearly stated on the label.

Reference:  IVDD_legislation_guidance_-_PDF.pdf (publishing.service.gov.uk)

UK Device Registration Deadline Approaching – Less than 30 days to go!

Devices being placed on the UK market are required to be registered with the MHRA from 01 January 2021 with a grace period ending 01 January 2022.

Non-UK Manufacturers are required to appoint a UK based UK Responsible Person to act on their behalf and support the registration process. This has to be done in addition to the existing European CE marking. 

With less than 30 days remaining to complete this process, we can help you through this device registration process, and maintain onwards compliance for UKCA marking from 01 July 2023.

SALE NOW ON – DECEMBER ONLY, 50% OFF RETENTION FEE FOR 2022! 

Contact us now for further information on [email protected]

So, we’ve been waiting patiently for months to find out the governments view on the consultation details. We were teased with various dates, told that local elections were the reason for the delay and then finally it was released by stealth on a Sunday! It is important to remember this is not the final regulation it is the government commenting on the majority responses from the consultation which should at least give an indication of what we can expect from the final regulation in the coming months. 

On initial reading it does appear that the UK MDR will be closely aligned to the EU IVDR, even if terms and descriptions do not directly reference that regulation. For us there are 5 standout items in the extensive and detailed commentary 

UK Responsible Person

The UK Responsible Person requirement is established, this has been a requirement since January 2021 and the government have confirmed this will continue to be a requirement. There was whisperings that this was going to be rolled back, however this requirement has remained. 

The UKRP must also have a permanent location in the UK at which they are physically located, which will exclude those currently located outside the UK but using a forwarding address. In addition to this they have directed that this function must have a Qualified Person continually and permanently at their disposal. Manufacturers are also required to have a Qualified Person in place. We’re very happy to report IVDeology UKRP Ltd qualifies going forward and will continue to support our customers in offering our friendly and flexible UKRP service!

Classification

The UK will move to a 4 level (A – D) risk-based classification system for in vitro diagnostic devices based on the IMDRF document “Principles of In Vitro Diagnostic (IVD) Medical Devices Classification” This is aligned to the EU IVDR but may see subtle differences in practice with a small number of devices moving between classifications, this includes Genetic tests and Companion Diagnostics. This requires further review and investigation.

Health Institutions

Greater controls over “in-house” manufactured or modified devices will be introduced to the extent that the health institution must have a full Quality Management System in place, the device must follow the relevant essential requirements of the UK MDR and must register those devices with the MHRA. There has long been a need to control the use of such devices and there should be a route for these institutions to access support in building their QMS and documenting the device technical information.

We are expecting the new update to ISO15189 in the coming months so it will be interesting to see how this fits into the new regulation.

MHRA Database

There will be a new Great Britain Registration database which will be more comprehensive than the current MHRA DORS. 

The government will be exploring how this database can operate as part of a series of integrated databases for capturing and processing information submitted to the MHRA about medical devices (such as data on registration, vigilance, post-market surveillance, and market surveillance regarding medical devices). This database will capture information around UDI and will utilise the GMDN device nomenclature system. 

We broadly applaud this move towards improved traceability, hoping that the process remains robust and efficient.

Transition Timelines

The Transition arrangements for devices holding a valid EU IVDR certificate or UKCA certificate will run until expiry of that certificate or for 5 years post implementation of the UKMDR, which ever is sooner. 

As with the transition to the EU IVDR if there is a change to the design leading to an update of the certificate or a change to the intended purpose then the need to comply will come into force. Equally, the post market requirements of the new regulations will apply immediately on full implementation. 

As already stated, this is not the new regulation, only an indication of the direction the UK government is taking from the responses and statements delivered via the consultation. It is clear that they are looking to ensure access to the UK market for safe and effective devices is controlled but not impossible to attain. 

IVDeology is always happy to talk to manufacturers outside of GB and NI about their UK Responsible Person requirements, this is already a regulatory requirement that manufacturers should have in place. Equally if you are not satisfied with the service you are being provided at the moment or that your current UKRP will not meet the requirements stated in point 1 please get in touch! 

If you are interested in discussing further what the new UK MDR could mean to your organisation going forward and thinking about initial preparation for transition please do get in touch at [email protected] or book a virtual meeting with Nancy or Stuart to discuss further.