Its here! After 5 short years, through Brexit and Covid-19, the deadline for IVDR transition is now less than 30 days away – where did the time go?!
I have spent the majority of my time within Regulatory Affairs being aware of the IVD Regulation, either in draft form, or as a published text. 5 years was always going to be a challenging timeframe, even without the additional complications we have seen in the last 5 years. The new regulation presents a seismic change to the way IVDs are regulated in the EU.
Many companies have made steps to be ready for the transition, either having updated to IVDR compliance, or are in process, taking into account the additional time limits for classes A (sterile) B, C and D. However some are still chasing their tails to get ready for the deadline.
Key areas of focus for IVDR DOA
Post-Market Surveillance
Vigilance
EUDAMED registration
Technical Documentation Processes
Person Responsible for Regulatory Compliance
It is critically important that the IVD industry is aware of the changes, and what needs to be updated to be compliant by the date of application. IVDeology have a great team of friendly experts who are working with multiple IVD manufacturers get ready for IVDR compliance, Contact me for further information on how we can help you. [email protected]
Have you seen our app? Search for ‘IVDEOLOGY’ in Google or Apple app stores to get a free IVDR reference tool.
About 9 months ago I took up sailing as a hobby. Being near the water I thought it was a great way to get my head away from the office. Over the winter season I purchased a lovely old second hand dingy (a Miracle). The idea is that over the coming years me and my son can learn to sail together.
Last week was the first time I attempted to get the boat on the water. As a novice sailor I went through a check list in my mind on all the elements I needed to make sure the rigging and sails were all ready to go:
Sails secure? Check,
Main sheets ready? Check,
Rudder attached? Check
So off I went onto the river Medway in Kent. The wind caught my sails, and I was off.
But then I realised the rudder wouldn’t stay down, and the bungs (the plugs that keep the water out) were broken and ineffective. So, I was effectively sailing in a boat without steering and sinking – not a perfect situation to be in!
Fortunately, I sail in a group of experienced sailors, with a safety boat close at hand to help. With their help I was safely towed back into shore when I can fix the boat. While this wasn’t a very positive experience it did teach me the importance of two things:
1.Do a complete health check of your boat before heading out, use a mental or written check list if possible,
2.Always reach out to other experienced people who can spot things you can’t.
The same 2 points are relevent to Quality Management Systems. If you have a new, or established QMS, whether ISO13485 or ISO9001, the way it is used will always change, continuous improvement is key to maintaining a safe and effective system.
IVDeology have an experienced team of Quality and Regulatory experts who can perform a Quality Health Assessment on your system. We can complete an independent overall system review against the relevent standard and regulatory framework (e.g. IVDR, MDSAP, FDA, UKCA) with an open and positive mindset to help you understand what opportunities you may have to improve your system.
Helping you understand the state of your Quality System now, will give you as best a chance as possible to navigate IVDR and UKCA transitions.
IVDeology UKRP Ltd has now been assisting non-UK manufacturers register their products with the MHRA since January 2021 so we thought we’d share what we’ve seen ourselves over the last 17 months.
5 Top Tips for Device Registration in the UK
Identify and appoint an experienced UKRP provider
Know your UK portfolio
Prepare your technical documentation
Check you GMDN classification
Plan for UKCA transition
When we engage with a manufacturer, we perform a number of due diligence checks on the manufacturer and their technical documentation. As we are effectively representing the manufacturer on the UK market it is imperative that we understand their level of compliance, identify gaps and close any before we apply to the MHRA.
In the early days we encountered minor issues with the letter of designation, even though we had constructed our letter with the help of a medical device focussed legal team. We adjusted our checklist to ensure that the checks are made on the addresses shown and as we are quality and regulatory consultants, reviewing the necessary detail is always ensured. We will work with the manufacturer to ensure that an application is accepted first time.
We are continually reviewing our onboarding process for the UKRP service to make it as straight forward as possible for our manufacturers. However, we must perform the appropriate due diligence on the technical documentation and certification.
We have quality, regulatory and technical experts as part of our team supporting our customers, and we fully understand both the terminology and the identity of certificates and documentation required.
It would seem from the MHRA document that they have encountered applicants who do not fully understand the requirements or have missed the upload piece. It does concern us that falsified certificates have been identified, we will always check the validity of the certificates provided and we’re happy to say that we have not encountered this.
One area that we have encountered on more that one occasion is the lack of GMDN codes being provided at the initiation stage, we have to ask the manufacturers for these codes or indeed update them as they were assigned many years ago.
Manufacturers should also perform their own due diligence when appointing an UKRP service provider, they must ensure that they will be getting the correct support and level of service. If a vigilance case is identified on the UK market, the manufacturer needs to be assured that 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 UK market.
It is with a view to ensure responsible delivery of UKRP services that the British In Vitro Diagnostic Association (BIVDA) have set up a directory of service providers UK Responsible Person Directory (bivda.org.uk). This is a voluntary directory but gives the contact details of a number of responsible service providers who are confident of providing the level and detail of service manufacturers need. IVDeology UKRP Ltd are proud to have been involved with the initial set up of this directory.
Nancy Consterdine
Director of Training & Compliance Services
For more information on UKRP, UKCA, and how we can help you achieve market access in the UK, contact us [email protected]
This week has been an interesting one for my family. After being so careful over the last 2years SARS-Cov2 has finally reached our household with my son and wife testing positive this week. Both are fit and well thankfully (apart from the odd cough and achy muscles), but it has meant that we have all been testing ourselves daily with the Lateral Flow tests.
This daily ritual re-enforces the need for effective usability studies to be carried out for in vitro diagnostic medical devices, such as the lateral flow tests, to make sure that these devices can be used quickly, effectively, and safely by any untrained personnel. Under the EU IVD Regulation 2017/746/EU, usability in built into the performance evaluation and clinical performance using the standards IEC 62366-1:2015 Medical devices — Part 1: Application of usability engineering to medical devices, and ISO 14971:2019 Medical devices — Application of risk management to medical devices among others.
One of our expert consultants Anne-Marie Turner considers why usability is important to the IVD design and development process:
“Usability studies are important as they validate the safe and effective use of a device against the intended purpose by gaining evidence from the users, it is a measure of effectiveness, efficiency, and satisfaction to demonstrate that no harm occurs.”
A key part of this is really understanding your intended purpose, including your intended user and intended use environment. Knowing these basic details for your device really does make a difference, as you can really focus on the key risk elements which need to be considered:
How will a lay-user actually use this test?
Are the instructions clear enough?
How may they be harmed by using the device?
How can we reduce as far as possible the risk of getting an incorrect result?
The IVDR goes further than the IVDD in really asking manufacturers to consider the usability of devices as part of the Post Market Surveillance activity once the device is being sold on the market. Pro-active assessment of real word user experiences should be performed as a regular part of PMS to fully understand, and react to, any changes in the way the devices are being used, and for what purpose.
Anne-Marie sums it up nicely by adding “usability is there to ensure the safety aspects for people using it”, and in that respect, I am very proud to be in an industry that ensures the lateral flow tests we use on ourselves, and our children are designed to be as safe and effective as possible.
Stay safe all!
Stuart
Anne-Marie has worked with many IVD companies designing usability studies as part of the wider design and development process. Contact [email protected] to learn more.
“Take nothing on its looks; take everything on evidence. There’s no better rule.”
-Charles Dickens, Great Expectations
This week at IVDeology, we have been speaking to many IVD (in vitro diagnostic) manufacturers regarding the expectations from the investors on the timeline for obtaining a CE mark for their devices. For many SMEs, the funding opportunity is associated with the timelines for delivery. While it is true that placing devices on the EU market with a CE mark has been reasonably straight forward under the existing IVD Directive 98/79/EC, the days of ‘quick’ market access are coming to an end.
From May 2022 (is it really only a few months away?) IVDs placed on the market in Europe will be required to meet the requirements of the IVD Regulation 2017/746/EU. With this change in regulation, the need to demonstrate safety and compliance is based on evidence, collected in most part before the device is placed on market, The need to establish scientific validity, analytical performance and clinical performance is centric to the device performance evaluation requirements. Collecting such data takes time, money and resource. Investors need to understand that this is an absolute requirement, and cutting corners as part of the design and development process will putt the overall project design process at risk.
The establishment of a clear regulatory strategy, within a well constructed quality management system is the best way to achieve CE marking success. The more investors reassess their expectations by understand these principles, and the mechanisms required to achieve the compliance, the greater the change of placing safe and effective devices on the market.
IVDeology provide consultancy, training and compliance services to support IVD CE marking, UKCA and RoW registrations. Contact me for more information [email protected]
Charles Dickens spent some of his childhood years in Chatham, Kent. His father John, worked as a clark for the Royal Navy at the Historic Dockyard in Chatham, were IVDeology HQ is located.
As part of the requirements for UKCA due to come into force in July 2023, the MHRA will designate UK Approved Bodies to conduct conformity assessments on their behalf to check compliance of IVD manufacturers against the requirements for UKCA marking. These UK Approved Bodies are not able to complete conformity assessments for CE marking as an EU Notified Body, or visa versa.
The full list of UK Market Conformity Assessment Bodies can be found here:
Both databases will be updated frequently so it is well worth saving these links as a book mark!
The new UK regulation (MDR2002) text is expected in the coming months, however while you wait is it worth making some preparations:
Identify stakeholders for any UKCA transition projects
Collate information on your portfolio and sales figures to identify which devices will be transferred into UKCA, or discontinued
Make initial enquiries with UK AB to understand their availability and timelines.
We are currently engaging with our customers providing workshops based on the impact of UKCA marking. For more information on how we can help you, contact us [email protected].
Since 01st January 2021, all non-UK medical device manufacturers (including IVDs) have been required to appoint a UK Responsible Person (UKRP) to act on their behalf in carrying out specific tasks, in order to place their devices on the Great Britain market.
In summary, the UKRP’s responsibilities include the following as a minimum:
Device registration
Technical documentation review
MHRA engagement
Vigilance and complaint support
We are just over 7 months into the requirement and now that 01st May 2021 has come and gone, all Annex II List A IVDs should be registered with the MHRA. Annex II List B and Self-test IVDs have until 01st September 2021 to be registered and General IVDs have until 01st January 2022.
So, what lessons have we learnt so far for IVDs?
Letter of Designation
Non-UK manufacturers must prepare a Letter of Designation (LoD) to appoint their UKRP. This needs to be signed by both parties and is provided to the MHRA as part of device registration.
The device registration process will be a lot smoother if non-UK manufacturers and their designated UKRP ensure the LoD takes into account the following:
1) Manufacturer’s details, especially the name and address, are consistent within the LoD, Declaration of Conformity (DoC), EC certificates (where applicable) and the device registration application;
2) Include an expiry date for the LoD;
3) Attach a list of all IVDs (device name and code) to be registered to the LoD;
When compiling a list of IVDs to be registered, I urge manufacturers to check that device names and any reference codes are consistent with, i.e. appears the same as, other documents such as labels, DoC and EC certificates. The UKRP will use this list to register the devices and getting it right first time will reduce the risk of application rejection.
Manufacturers also need to consider and communicate with their UKRP what device information they want printed on an MHRA Certificate of Free Sales (CFS). Do you just want the device name to be printed, or do you have different models and reference codes that also need to appear on a CFS?
GMDN Codes
Global Medical Device Nomenclature (GMDN) codes are used to name and group medical devices and are required as part of MHRA device registration. Manufacturers need to register for an account on the GMDN website (https://www.gmdnagency.org/) to obtain GMDN codes.
Manufacturers should aim to obtain GMDN codes, for every IVD to be registered, early in the process. Include them in the list of devices to be registered that is provided to the UKRP. Without them, submission of the registration application can be delayed.
As an aside, where manufacturers have more than one device with the same GMDN codes, the UKRP can register the devices using a bulk upload. This saves a lot of time and will speed up the UKRP’s preparation time for the device registration application.
Experience
Finally, manufacturers need to find the right people with the experience to help walk through the process. Device registration is just the beginning, and this includes technical documentation reviews by the UKRP. Finding and appointing a UKRP that is the right fit for a non-UK manufacturer will pave the way for a smoother ride further down the line. This is critically important as we get closer to understanding the new requirements of the UKCA process, where the UKRP will play a key role to providing information back to the manufacturer.
Key points for non-UK IVD manufacturers to consider for appointing their UKRP and MHRA device registration:
For more information on the UKCA/UKRP responsibilities visit our websiteor contact us to find out how we can help you with our UKRP service [email protected]
Quality Management System – three words that bring dread to people new to the industry and in my experience to some people who have been in the industry for years. In the almost 20 years I have worked in the industry I have worked on both sides – the side trying to circumnavigate round the Quality management system (QMS) and the side trying to ensure that it is followed and maintained. But what is it and more importantly why is it needed?
A QMS is defined as a formalised system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. Sounds complicated but what does that really mean?
A QMS is the way you document what you do and how you do it. It identifies the activities required to meet both your customer and regulatory requirements. It includes the documentation that controls the manufacture and release of your product, the controls in place to ensure materials you buy conform to the specification you require, the training completed to allow people to do the job correctly, the instructions on what to do if something goes wrong, how you control updates to documents, to name but a few.
For IVD’s, the industry standard is ISO13485:2016, where manufacturers can achieve a certificate of conformity from a notified body. Certification is an easy way of demonstrating to your customers your commitment to quality and that you have the required controls in place to manufacture a reliable, safe and effective product. However, whilst this is highly recommended, it is not mandatory. Annex I of the IVD Directive states that the manufacturer must reduce risks as far as possible or take adequate protection measures in relation to risks that cannot be eliminated. It is therefore vital that to ensure that you have procedures for controlling the highest risk activities in your manufacturing process.
However, many QMS’s present artificial barriers to the company and therefore people spend an extraordinary amount of time trying to find ways to avoid following it. I have often wondered that if even some of this time had been spent trying to improve the process rather than finding new ingenious ways of trying to avoid it, how much better off the company would have been. It is therefore important that when building your QMS that you try to ensure that it aligns with the existing workflow so it works with the company rather than against it.
So other than a regulatory requirement that you must meet, what are the benefits of the QMS? It gives you a framework for controlling and ultimately improving your processes. It is the way you ensure that the final product is made right first time – helps to prevent mistakes, reduce discards and therefore lowering your production costs. It helps to ensure that you meet your customer requirements and that customer satisfaction is preserved. This helps build confidence in your company and ultimately leads to more sales both from new customers and returning ones.
So rather than consider the QMS as a tick box exercise to enable you to get on the market, if done correctly, a QMS would definitely be an asset to your company and not just a regulatory requirement.
Happy April 1st everyone! It feels we can all take a collective deep breath. We got through lockdown, Brexit came and went (which identified its own problems – but that’s a different blog!) so it feels that we’ve made it! So I celebrate this day by sitting in a sunny spot sipping my freshly brewed coffee, then it hit me – ‘Holy Moley, IVDR is coming!’. For being such an enormous dark shadowy figure looming on the horizon, we lost sight of it in the fog of the events of the last few months. But now the need for preparing for this transition is fully in focus.
We know that (at the time of writing) the IVDR will fully come into force on 26th May 2022. It presents a seismic change in the way IVDs are regulated within the EU. It replaces the aged and slightly creaking IVD Directive with the overall aim to make IVD devices placed on the market safe and effective, but it is a significant uplift on the current regulatory requirements.
Conservative estimates for a transition from the IVDD to the IVDR for manufactures is minimum 12-18 months taking into account the interactions with notified bodies, conformity assessments, technical file sampling, and for class Ds the additional burden of external testing labs and availability of common specifications. The upshot of this is that if you intend to maintain devices on market under the IVDR from May next year, you should be well under way in your transition activities.
From our experience we know there are some common areas that require much focus:
Intended Purpose statements
Use and control of economic operators
Packaging and labelling updates
Performance evaluation
Technical file remediation
Quality Management System updates
Each piece of this jigsaw can take many months to plan, review and implement changes. All this needs to be done before the EU notified body reviews your systems. The resource and time required to do this should not be underestimated so planning and budgeting is essential.
To add further complexity, we are just over a year away from implementation, and we still only have 4 notified bodies designated to the IVDR. While these notified bodies are established and ready to support the industry, it seems to me that this is a very small funnel to put a very large number of devices through to compliance. There will be a time soon where the available notified bodies will not be able to support further customers, either under the IVDD or IVDR framework. The availability of these gate keepers is a real concern and should be keenly watched in the following weeks and months ahead.
We also know that the European Commission is behind on providing the suitable framework for the IVDR to be fully implemented. There are still many unknowns regarding Eudamed and Common Specifications for higher risk devices, just think of the number of Covid-19 devices placed on the market in the last 12 months alone. Without sufficient guidance, strategic planning for transition is more and more challenging.
So where are we going to be in 12 months’ time? Will the IVD industry be ready for the IVDR? This is the million-dollar question. Personally, I think we are far behind where we all thought we would be two years ago. Unless the European Commission considers an extension to the transition process, the industry be facing significant, time critical hurdles. The potential scenario where devices will not be available on the market is a very real risk, and this will have significant implications to the healthcare system.
While there are still many unknowns, and it may be difficult to navigate through the complexities of the IVDR transition, I think it is important to not wait for answers from either the commission or notified bodies. The IVD industry needs to pick a path towards the IVDR and crack on! And don’t pin all your hopes on a delay to the IVDR timeline, as it may never come, and hope is not a strategy!
