Under new guidance published on 1 September by the MHRA, from 1 January 2021 all non-UK Medical Device and IVD Manufacturers are required to appoint a UK Responsible Person to place devices on market in Great Britain. IVDeology Ltd can support this role. Contact us for more information.
Last week I was able to rent and watch “Star Wars: The Rise of Skywalker” and take the edge off the ongoing social distancing in our household. If you haven’t seen it (I won’t share any spoilers) it finishes the series off nicely. But it reminded me of the common response when I moved from a Technical role within an IVD industry to my first Regulatory position many years ago…
Oh NO!! You’ve joined the DARK SIDE (Queue dramatic music here!)
The initial move was actually quite a challenging move and I really struggled to change my perspective from being on the other side of the RA line. From a busy lab environment to the quiet office work of Regulatory Affairs, it was a very different type of work and a different series of deliverables, but certainly no less challenging. Very early on I realised that the more you read, and having a thirst for knowledge, the more you develop an understanding of the IVD regulations. The diversity of the day to day challenges was immense, from global trade compliance, product registrations, packaging, animal origin certification, design changes to risk management – I had to cover so much ground throughout the organisation I was working for at the time. It took many months to get a full handle of the roles and responsibilities from the day to day function of a RA professional.
At first it felt like a different world to my old technical roles. But actually, the knowledge and experience that I had developed from manufacturing and technical functions really provided a solid grounding for the new RA role. My technical understanding of the products, and the method of manufacturing was so important to assess the state of the technical submission files and design changes that I would be reviewing as RA. Without this experience I would not been so effective in my role. In addition, I had a good understanding of a non-RA perspective when compliance issues came up. Half the battle of RA is to be able to clearly and objectively relay the key regulatory requirements and expectations in a way that the other person can understand and appreciate. Can you get the key information across in 5 minutes before they just switch off as its “just RA stuff!”.
So all my working life, from jobs in pie factories (for 3 days), warehouses, tourist ferries, sport centres and then IVD companies, has resulted in me turning to the dark side. So on this day I would like to think that in turning into the Regulatory Affairs professional I am , I’ve also been able to bring some of my Jedi skills with me too…. Stay safe in the this period of continued Covid-19 lockdown and above all… May the 4th be with you!!
Me donning my Sith cloak (fleecy dressing gown in these self-iso conditions). 😊
IVDeology Director Stuart Angell talks through the 10 steps to the IVDR transition process via the link below:
In September 2018 I wrote a post on the impact of the EU IVD Regulation on Economic Operators (check it out here https://www.ivdeology.co.uk/blog-2-the-roles-and-responsibilities-of-economic-operators-under-the-ivd-reg)
As we speed through 2020 and towards the implementation date for the IVDR, the team here at IVDeology are getting a great level of interest and questions from UK based distributors, importers and authorised representatives about how the change of regulation will impact them. Some have a good relationship with the IVD manufactures and are more informed of the impact on their business, others are still very much in the dark and are getting nervous on what they need to adapt to survive beyond May 2022.
Our aim is to provide clear and simple regulatory advice to the IVD industry, including authorised representatives, importers and distributors. Therefore it is with great pleasure and excitement that today we would like to announce our first workshop presented by IVDeology on the impact of the IVDR on Economic Operators. The 1 day CPD certified course will provide a top level view of the impact of the IVDR using presentations, discussions, working sessions and Q&As with our experts.
The course will be held at the wonderful location of Historic Chatham Dockyard in Kent and lunch will be included.
Spaces are limited so if this would be of interest to you please e-mail us at [email protected]
Covid-19 is starting to have a huge impact on all companies big and small. At IVDeology we are all fit and healthy but have taken the steps to self-isolate and work remotely from home (I am writing this from my kitchen!). While we miss the interaction that being in an office can bring, we are learning how to work more effectively using remote tools. At this point your company may be doing the same thing.
It may be challenging for companies to find suitable remote working activities, especially as many roles within IVD manufacturing cannot be performed working from home. However, with the IVD Regulation coming into force in just over 2 years time this is the perfect time to engage with all functions to consider the impact of the IVDR on your products.
The generation of product Technical Files should be a cross-functional activity that requires a collective effort across the business. Much of this can be done remotely by non-regulatory or quality experts. Here are some questions you could ask yourself:
IVDeology aim to be the UKs leading provider in IVD regulatory and quality services and we have the tools and a number of experts who can support your teams in the assessment and remediation of IVD technical documentation, either in person, or remotely as part of Covid-19 self-isolation!
For further information on what you need to know, and how we can help contact us [email protected]
A review by Nancy Consterdine, Director and Co-founder of IVDeology Ltd
As we near our 2nd birthday it seems like a good time to look back at our successes over 2019. We started out in January having our 1st anniversary, at the time the team still stood at 2, myself and Stuart but that was very soon to change.
JANUARY
Late January saw Anne-Marie Turner join us as a project manager working to deliver a QMS, Design History file and consequent Technical File for a small start-up funded by the Boost4health initiative (in association with Kent County Council). This partnership proved successful with CE mark approval being delivered in December 2019. We’re very proud of this success and our continued association with ExSeed Ltd.
Nancy presenting at he TOPRA Masterclass
FEBRUARY
February saw Stuart and myself presenting lectures for the TOPRA IVD Masterclass, this is always an interesting few days and we normally end up gaining insights into a subject area or two.
MARCH
March brought our first international contract with providing IVD Regulation training to a large US based manufacturer. We were fortunate enough to be able to also take our families with us and spend a couple of days enjoying New York before work started in earnest. We delivered bespoke, quality Management focussed training around the IVD Regulation and the major changes impacting the industry.
We also we able to have a half day practical implementation workshop with them which proved very popular.
A family outing to see the Statue of Liberty in new York
March also saw a trip to China; we were supporting workshops on building Technical Documentation in compliance to IVDR for transitioning (legacy) products.
APRIL
April brought a new contract for me, working with a company developing a purely digital medical device. I was there to support a major revision of their QMS and to guide them in building the technical documentation to ensure transition to Medical Device Regulation compliance. This contract ran for 6 months and whilst providing me with valuable experience it did remove me from IVDeology, an experience that Stuart and I have agreed should not be repeated for either of us. Our focus is the successful growth of IVDeology.
May was an extremely important month, Joanna Angell joined as Employee No 1. Jo brings 18 years of experience within the IVD industry and has been a valuable asset since she joined. Two became 3 and we started to look to the future, planning for the 2nd half of the year. As a company we want to support local business and flexible working, giving opportunities to experienced, valuable professionals who, for whatever reason, need flexibility in their working day.
May also saw us back in the United States, this time to run more implementation focussed training sessions and workshops. We delivered Executive level training on the business impact of IVDR, this regulation is not just for transition, it is for life.
June and July brought well-earned holidays and the team steadily working to deliver on the current projects. July was also the month that Stuart visited the fourth country of the year, Japan, for more transition workshops.
Stuart also presented to the Westminster Health Forum on behalf of the British In Vitro Diagnostics Association (BIVDA) on the current climate within the IVD industry.
Stuart as the vice chair of the BIVDA RAWP Seminar
AUGUST
August brought a trip to our third country of the year, Poland, to deliver ISO13485 training and initiate the project with another start-up. Working with them to initiate their QMS right at start of design and development shows the CEO understands the importance of quality.
SEPTEMBER
September brought the end of my 6-month contract, I could focus fully on IVDeology again and we took the chance to spend a week looking at the business and forming a development plan.
OCTOBER
October brought trips to the US and Poland again and also the BIVDA Seminar which was held in Manchester. We were both presenting, and Stuart was particularly busy in his role as Vice Chair of the Regulatory Affairs Working Party. There was an increase in the number of delegates again which I think is indicative of the increased momentum as we move towards the IVD Regulation transition deadline.
Nancy hosting an ‘ask the experts’ session on software at the BIVDA RAWP Seminar
NOVEMBER
November saw one of our projects conclude with the delivery of a CE marked device. This was an important milestone for us. We also delivered more bespoke training courses in the US under the IVDeology name and in London for Management Forum. We also moved into our office which is situated in the Historic Dockyard, Chatham.
DECEMBER
December was not the quiet wind down we were expecting as the end of the year approached. We were busy with our existing projects and also excited at the conversations we were having for possible new projects and collaborations going forward. We took time to really review our ongoing resource and made plans for the new year.
Stuart me and Joanna at the BIVDA RAWP Meeting in December (with Christmas jumpers!)
So as the 19th January approaches we can look back and say that 2019 was a very successful year for us. We are also looking forward to another busy year for the growing IVDeology team. We will be concluding some projects and obviously working on some exciting new ones and we sincerely hope it will be just as rewarding.
IVDEOLOGY LTD are pleased to announce that we’ve signed up as an exhibitor at SEHTA’s 2020 International MedTech Expo & Conference, which is taking place on 26 March at Hilton London Tower Bridge Hotel.
Come and join us at this prestigious event to meet other like-minded SMEs involved in Digital, Devices and Diagnostics.
This event is The SME focused healthcare event for driving collaborations between Business, Care & Clinicians & Academics.
For more information please visit www.sehtamedtechexpo.co.uk
Stuart, Nancy and Jo at the BIVDA Regulatory Affairs Working Party (wearing Christmas jumpers).
As we drive towards the end of 2019, and the run up to Christmas it is a great opportunity to reflect on the year that was, and look forward to the challenges of the year to come.
IVDeology have had quite a year. Working within the IVD sector. We have worked with small start-ups and large businesses alike, we have been involved in long term projects, short term consultancy, and had the opportunity to help provide several training sessions on the impact of the IVDR.
In light of all things Christmassy, and taking inspiration from Charles Dickens who resided in Rochester, Kent, please allow us to consider the impact of the ghosts of Christmas past (Legacy products), the ghosts of Christmas present ( a reflection of the current state) and the ghosts of Christmases to come (what does next year look like)…
The Ghosts of Christmas Past (Legacy Products)
Classification: With less than half the transition period left before the full implementation of the IVDR most IVD manufacturers have made an assessment of the device classification. With no grandfathering allowed for old (legacy) products which are transitioning to the IVDR, the headache inducing task of reclassifying previously self-declared non-Annex list II devices into Class A (low risk), Class B or Class C (Med-high risk) is required. While the rules defined within Annex VIII are well laid out, there continues to be grey areas between the device classes.
Intended purpose: Part of the complication associated with device classification is that the intended use statements describing the device under, or before the IVD Directive do not always provide sufficient detail or consideration to the Intended Purpose under the IVD Regulation. Effective classification of devices is highly dependent on establishing the way the device is used within a clincial setting, including the intended user and device function.
Clinical evidence: The established (state of the art) method for generating analytical and clincial performance data when many legacy devices were originally developed does not meet the elements of current methods, typically using CLSI guidelines. The manufacturers challenge is to provide sufficient narrative to demonstrate how the original data, or other data sourced from literature reviews or performance studies for these devices continues to be a challenge.
Economic operators: Whilst the elements of economic operator responsibilities seem straight forward on first glance. The complexity of modern day supply chain has made the delineation of economic operators and responsibilities more challenging than expected. The limited real estate of the device packaging and IFU also requires careful consideration.
The ghosts of Christmas present
Notified bodies: The medical device and IVD industry has long feared the bottle neck for the supply and demand of Notified Bodies who can provide conformity and techncial assessment for device under the new Regulations. In reality, with the loss of LRQA and UL as NBs from the sector, manufacturers are already starting to feel uncomfortable. SME IVD Manufacturers who are engaging with Notified Bodies for the first time are seeing delays and additional costs for the assessments of their devices. While we fully understand the additional burden that notified bodies are currently under, the current availability of Notified Bodies continue to be a challenge.
Further guidance: The IVDR provides much greater granularity than the existing IVD Directive, however there remains some areas of the regulation where the detail is still a little light! With Eudamed delayed and implementing acts for new elements of the regulation being delayed, there is a real need for additional clarity to support the IVD Industry to navigate the transition process.
Brexit: Not only do we have the IVDR to contend with, the UK sector have the additional uncertainty of Brexit (which may or may not be resolved by the time of publication). The changes to mitigate the impact of Brexit, additional requirements for UK responsible person, importer considerations and stock piling of devices in preparation for a hard Brexit has required additional resource and cost which can impact the IVDR transitions projects.
The ghosts of Christmas to come
Over a hurdle into a platform: A key message that we try to impart when discussing the IVDR impact is that there is not a simple hurdle to get over, then back to the status quo, the IVDR establishes a new approach for the regulation of IVDs being placed onto the EU market. The additional requirements of Post Market Surveillance and Persons Responsible for Regulatory Compliance will require additional resource to support the product on market.
EUDAMED: The generation of the Eudamed database and UDI offers a sea change in the way that devices are monitored, identified and managed on the EU market. While some elements of Eudamed have been establsihed, the detail on the function of Eudamed is still to be determined.
Hope is not a strategy: The main conclusion from this year is that despite the uncertainty on Brexit and many elements of the IVDR, it is important to start doing something! A transition plan should be started using the current guidance, in addition it is important to expect that your processes and understanding of the regulation to change.
The IVD Regulation really is the gift that keeps on giving – it is for life, and not just for Christmas.
IVDeology are proud to have been involved in the Boost4Health project in the last few years:
Between 2016 and 2019 Kent County Council was a project partner in the EU funded Interreg North-West Europe Boost4Health Project. This project provided practical and financial support to small and medium-sized enterprises in the Life Sciences sector in North-West Europe who wished to explore their international growth potential and innovate in their business.
It helped companies to:
To find out about how to contributed to this success please visit https://www.kentinternationalbusiness.co.uk/2019/1…
The MHRA has updated its guidelines for “Regulating medical devices in the event of a no-deal Brexit – What you need to know about the regulation of medical devices in the UK if we leave the EU with no deal” on 18th September 2019…
The guidance offers greater clarification on who can become a UK Responsible Person. The term Person can be either a sole trader or a company but it must be UK based.
“If a company establishes itself as a UK Responsible Person, the responsibilities of the UK Responsible Person would fall to the company as a whole. This is the same situation as for an EU Authorised Representative.
If you are a UK-based importer and you wish to place a device on the market, you must have the authority from the manufacturer before doing so. This means that you will become a UK Responsible Person.”
While there is a grace period for the appointment of a UK Responsible Person (4 months for Annex List A IVDs, longer for non-Annex List A) we would recommend having conversations with companies who can offer the UK Responsible Person service as early as possible.
IVDeology Ltd is a UK based company which have a highly experienced team of Regulatory, Quality and Technical experts who can act on behalf of non-UK based IVD and Medical Device manufacturers. We are offering our UK Responsible Person services to all IVD and Medical Device Manufacturers offering guidance and support during the Brexit transition, as well as UK and EU IVD and Medical Device Regulation changes.
For further information contact [email protected] so that one of our team can discuss how we can help you.
Are you looking for an EU Authorised Representative to place IVDs and Medical Devices into the European Market? contact us for further information on how we can help.
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