Welcome to the Mindset Extended Reality (XR) for digital mental health programme learning resources, which include three series: medical regulation, clinical evidence and lived experience involvement. Mindset-XR is helping to catalyse the growth of immersive digital mental health solutions in the UK, through funding, tailored support and training. It is delivered by Innovate UK and the Health Innovation Network South London (HIN).
This series focuses on medical regulation, with key insights from Hardian Health. Across 10 modules, we provide an accessible introduction to people and companies that want to learn more about medical device regulation, with a focus on XR devices. Each module offers a high level overview of a different topic, including medical device regulation in the UK and EU, core medical device standards and overseas regulation. Each module includes additional resources to support your learning and a quiz to test your understanding.
Outline
Welcome to Module 9: Timelines and costs for regulatory processes. In this section, we’re looking at the costs and timelines associated with medical device regulation. Topics include:
How do I start regulatory processes?
An overview of when to start regulatory processes.
What are the key timelines and costs for regulatory processes?
A closer look at the set up and cost of Quality Management Systems (QMS), technical file, registration and notification fees, and staff and training.
Multiple choice questions to test your understanding of the costs and timelines associated with medical device regulatory processes.
How do I start regulatory processes?
When should you start your regulatory strategy?
It is best to consider your regulatory strategy soon as you have a concept or idea for a medical purpose.
It is far easier, cheaper and quicker to consider regulatory compliance early than to ignore it until the last minute. ‘Regulatory debt’ is expensive! Non-compliance can be fatal to a business.
Your first device certification takes the longest and is the most expensive, as you need to start from scratch. After this, each subsequent device certificate should become faster and cheaper. This is possible if you have built your regulatory strategy appropriately.
Regulatory readiness levels
Ideally, you should start applying quality assurance as soon as you want to translate research into development. This is when the possibly divergent ideas for a technological solution to a problem start to converge into a product idea.
We apply a Technology Readiness Level (TRL) scale to self-assess this. It’s a scale from 1 to 9, where 1 is the most basic idea and 9 is a product that’s fully developed, put to market and in service; TRL 4 is about the level on this scale when the Design Control, Clinical Evaluation and Risk Management procedures really need to kick-in.
What are the key timelines and costs for regulatory processes?
Quality Management System (QMS) timelines and costs
QMS timelines
- Instilling a culture of quality into a company takes time, it doesn’t happen overnight just by purchasing a quality management system (QMS) or templates. Records must be kept beyond the lifetime of your device to mitigate against any adverse events.
Quality assurance is an ongoing process covering the lifetime of your device. Everyone in your company is responsible for ensuring quality – not just the quality manager!
Typically we recommend around 3 months to design a QMS, 3 months to deploy and train everyone and 3 months to actually use it before an audit. Therefore, a QMS can take up to 9 months.
QMS costs
A QMS should be built and not bought.
ISO standards
You need to purchase copies of relevant standards. We recommend having a subscription to take advantage of up to a 50% discount ~ £1500 annually.
QMS
Build a bespoke QMS in-house using Atlassian/Jira/Github/Google docs for around £12-16K (or you can choose to purchase an eQMS system costing up to £30K annually). Purchasing an off the shelf QMS does not make you automatically compliant.
Training
It is always cheaper to train internal team members to conduct internal audits rather than pay external auditors – training courses are around £2-4K pp. QMS auditors can also ask questions to any member of the team so all team members need to be appropriately trained.
Staff
We highly recommend hiring a quality manager as early as possible – estimated annual FTE cost £70-100K.
Certification
You should get ISO13485 certified by an accredited EU/UK body (ideally the same body that will audit your technical file for CE/UKCA) – costs range depending on company size and revenues – around £16K for small startups.
Recertification
Every three years you must be recertified – budget around £5K.
QMS costs summary
- Recertification – every three years you must be recertified – budget around £5K.
Ongoing ~£1.5K in updating standards annually.
Technical File timelines
The Technical File (TF) is how you document all processes and evidence while designing, building, deploying and maintaining your medical device.
- The TF contains both technical and clinical documentation. It is always better to document as you go along, rather than scramble to do it all retrospectively. It might slow down your development initially but it will likely save time in the long run.
Many documents and processes are ‘live’, and can be performed in parallel as you set up your QMS.
Technical documentation: assuming a functional QMS, you will need to conduct full risk analysis, software lifecycle development plan etc. This typically takes 2 to 4 months.
Clinical documentation: Systematic literature review (~ 2 weeks), Clinical Evaluation Plan (~ 1 month), conducting a Clinical Investigation (~ 3-6 months (some may take years)), writing it all up into a Clinical Evaluation Report (~ 1 month).
Many documents and processes are ‘live’ and can be performed in parallel.
Accreditation timelines
There is a long wait time for approved and notified bodies. Current quotes are between 12-18 months. Therefore, it is important to engage with a notified body or approved body and book your audit well in advance. However, you do need some skeleton documents in order to book an audit.
2 stage audit: This takes place over a couple of weeks. You will receive feedback within a month and be given a further month or so to respond to any non-conformities before a third stage audit.
Proper planning can align your technical file creation to be done while in the queue for an audit, however, to apply for an audit you will need some skeleton documentation first.
2-stage CE mark audit: prices range depending on notified body, device class and company size, but typically around £25,000. You can expect to pay more for an expedited review.
Unannounced audit fees: at least once every five years and costs approximately £5,000. Your team will have to be ready with more than 12 hours notice.
Many documents and processes are ‘live’, and can be performed in parallel as you set up your QMS.
Registration and notification fees
Clinical Investigation: The Medicines and Healthcare products Regulatory Agency (MHRA) must be notified in order to conduct an investigation of non-regulated marked devices. Class I, IIa or IIb is £7,472. Different fees apply in different jurisdictions.
Non-EU manufacturer deploying in EU: annual fee for EU Authorised Representative, which is approximately €2000.
Person Responsible for Regulatory Compliance (PRRC): if no-one is qualified in-house, then fees for an external appointment range from £1,000-£2,000 per year per device. If you have an appropriately qualified quality manager, this is a role they can take on.
Staff and training
Staff
We highly recommend hiring a quality manager as early as possible. Estimated annual full time employment (FTE) cost £70,000-£100,000
Training
It is always cheaper to train internal team members to conduct internal audits rather than pay external auditors. Training courses are around £2,000-£4,000 per person
Accreditation and registration fees
External experts can be brought in to assist, but do not expect them to do all the work for you. You must learn some of these processes yourself
Total costs
Quality Management Systems (QMS)
£40,000-£60,000 (6-9 months to set up, deploy, train and get certified)
Technical File
Costs for 2-3 full time equivalent (FTE) staff, or 1 FTE staff and external consultants. Estimated cost: £150,000 (total)
Accreditation and registration fees
£60,000 (12-18 months solely based on backlog of Notified Bodies)
Ongoing costs
EUAR, PRRC, staff training. Estimated cost of £10,000 per year
Summary
In this module, Timelines and costs for regulatory processes, we looked at the costs and timelines associated with regulatory processes. After using this resource, you should have a understanding of the following:
It is best to consider your regulatory strategy soon as you have a concept or idea for a medical purpose.
Quality assurance is an ongoing process covering the lifetime of your device. Everyone in your company is responsible for ensuring quality – not just the quality manager!
There are lot of timelines and costs associated with regulatory processes, such as technical file, accreditation, registration and notification fees, and staff and training. Although these can run in parallel, there can often be delays in initial timelines.
Quiz
Got questions, comments or feedback?Get in touch with the teamhin.mindset@nhs.net | hugh@hardianhealth.com
PowerPoint: Timelines and costs for regulatory processes – click to download
Next module – Module 10: What are the international regulations for medical devices?
Back to Module 8: How to apply medical device standards to XR