Blog - News and Updates

IVDeology – 2019 Review – Four countries and an employee

Jan 16, 2020

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. 


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 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 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 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 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 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 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 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 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.

An IVDeology Christmas Message

Dec 16, 2019

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.

Boost4Health Exceeds Expectations

Dec 11, 2019

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:

  • Expand their international networks
  • Find expertise abroad
  • Validate products in another market through accessing microfinancing

To find out about how to contributed to this success please visit

UK Responsible Person - Update in the event of No Deal Brexit

Sep 19, 2019

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 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.

IVD UK Responsible Person

Aug 21, 2019

As we gear up to the potential for a no deal Brexit under the guidance of our new Prime Minister Boris Johnson non-UK manufacturers of in vitro diagnostics (IVD) and medical devices (MD) need to make plans to ensure they can still place IVD devices onto the UK market.

Following guidance by the UK Competent Authority (MHRA) updated 8 August 2019, all non-UK Medical Device and IVD manufacturers must appoint a UK Responsible Person. This is a new role created under the UK MDR 2002 which will apply from the day the UK will leave the EU (31 October 2019).

The UK Responsible Person must be appointed by the manufacturer either by a letter of designation or similar contract, requiring the UK Responsible Person to:

  • Register devices within the MHRA DORS system
  • Check the availability and hold an up to date copy of the Declaration of Conformity and technical documentation for the device
  • Respond to any request from the Secretary of State and provide all the information and documentation necessary to demonstrate the conformity of a device
  • Forward to the manufacturer any request by the Secretary of State for samples, or access to a device and ensure that the Secretary of State receives the samples
  • cooperate with the Secretary of State on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices;
  • immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device

IVDeology Ltd have a team of regulatory and quality experts who can act on behalf of non-UK IVD Device and Medical Device manufacturers. We offer a friendly service to help guide manufacturers through the complexities of the UK MDR.

Contact us for more information  contact

UK Responsible Person for IVDs and Medical Devices

Aug 09, 2019

73 days to go….

Are you ready for the 31st October 2019?

Under the circumstances of a no deal Brexit, where the UK will leave the EU without an approved withdrawal agreement. All IVDs and Medical Devices placed on the UK market by a non-UK manufacturer will require a local UK Responsible Person. Similar to the EU Authorised Representative the UK responsible person is required to be appointed by non-UK based manufacturers to act on their behalf. Their responsibilities include:

  • Device registration
  • Post Market Surveillance Activities
  • Recall and vigilance activity
  • Act as a point of contact to the UK Notified Body

IVDeology are pleased to offer a UK Responsible Person service using our extensive knowledge of the UK and EU quality requirements and regulation.

For more information regarding this service please contact

IVDeology Ltd – Happy Birthday to Us

Jan 18, 2019

In other words – What a difference a year makes!

In November 2017, we received the news that we were being made redundant, this was where the idle chat of one day starting a consultancy business became reality. As December 2017 rolled on, the plans to start the company became more solid but we didn’t have a name. We liked the sound of Rochester View Consulting however it was pointed out that it sounded more like a retirement home! Then one day as Stuart was in the car with his son and thinking out loud around IVD and our ideology, his son shouted “idea daddy, idea!” The two words melded together and IVDeology was born.

IVDeology Ltd was registered at company’s house on 19 January 2018. We started building our quality management system, always with our company mission statement in mind

Company Mission

To provide a series of fundamental principles that can be used to achieve compliance to In vitro Diagnostic Medical Device and Medical Device regulations using a clear, pragmatic approach that can be easily transferred into the Quality Management System of any IVD or Medical Device company

IVDeology Ltd

Our vision statement seemed ambitious as we wrote it, although looking at it in January 2019 we have achieved two of the three aims already. We are fortunate to have good connections in the IVD industry and have found our membership of BIVDA and active participation with the Regulatory Affairs Working Party invaluable. We have been fortunate to have worked with a notified body and larger organisations but where we really excel is working with small start-up manufacturers and medium sized organisations. The chance to work with them, identify gaps and then deliver solutions to close the gaps is what we set the business up for.

We have also written and delivered several training packages based around the IVD Regulation and the impact on manufacturers which have all been well received. Helping organisations to understand where they will be impacted and then discussing possible ways to facilitate transition is interesting and rewarding, we hope to have more sessions like this in 2019.

It is safe to say IVDeology Ltd has developed further and quicker than we could ever have imagined as we were starting out last year. We can only say thankyou to colleagues past and present who have freely given advice and support during the year. Also thankyou to our clients, we have enjoyed being part of your organisations and working with you to give support and find solutions.

UK Authorised Representative if there is a NO DEAL Brexit

Jan 11, 2019

The MHRA has published further guidance on the regulation of In vitro diagnostic medical devices if there is a no Brexit deal. The current IVD Directive 98/79/EC has been transposed into UK law and will still be applicable in the UK after Brexit.

The UK will mirror all key elements of the IVD Regulation 2017/746 which will be brought into force in line with the EU transition with a full application in 2021.

After 29 March 2019, all IVDs will need to be registered with the MHRA prior to being placed on market in the UK.

“Where a device manufacturer is not established in the UK, registration of a product with the MHRA must be undertaken by a ‘UK Responsible Person’ established in the UK and with a UK registered address who will take responsibility for the product in the UK. No labelling changes will be required to reflect the role of this ‘UK Responsible Person’”

We believe that the ‘UK Responsible Person’ is aligned to the current EU Authorised Representative. The EU AR are appointed by the non-EU Legal Manufacturer to take on the responsibilities regarding registration, vigilance, compliance, post market surveillance and act as a communicationliaison between the manufacturer and the MHRA.

The UK Responsible Person would need to be appointed prior to 29 March 2019 in the event of a no deal Brexit.

IVDEOLOGY Ltd is a UK based company specialising in offering quality compliance solutions which will include representation as a UK Responsible Person in the event of a no deal Brexit.

We have a team of IVD specialists who can offer continued, effective quality and regulatory support for manufactures, importers and authorised representatives and distributors during the transitions through Brexit and the new IVD regulation at competitive rates.

If you are a non-UK IVD company, distributor or supplier we would love to hear from you to discuss how we can advise or support you.

Whatever happens as an outcome of Brexit, if you are a small or start up business, we can help your business navigate through this transitional period.

Contact us at or visit to know more.

Introducing the IVDeology App for iPhone

Dec 18, 2018

Before you open your crackers this Christmas we would like to present a a Christmas cracker of our own.

The team at IVDeology Ltd are delighted to announce the launch of the IVDeology IVDR App for iPhone. The app is an article by article, searchable reference tool for the in vitro diagnostic regulation (2017/746/EU). 

The app is free to download from the iTunes App store available here

We would welcome everyone to download, use and share with any regulatory colleagues around the world.

For those Android users, an Android app will be available in Q1 2019, if you would like information on its availability please contact us via our website, to know more.

From everyone at IVDeology Ltd, we would like to wish you all a wonderful Christmas and festive period a wonderful, and prosperous 2019!

The roles and responsibilities of economic operators under the IVD Reg

Sep 04, 2018

During the transition to the new IVD Regulation 2017/746/EU, manufacturers of in vitro diagnostic medical devices will need to include the understanding of the product distribution flow within their gap assessments to the new regulation.

The current IVD directive 98/79/EC details responsibilities for manufacturers, authorised representatives, importer and distributors. The new IVD Regulation which comes into force in May 2022 provides an update of those responsibilities.

Summary of Key Manufacturers Responsibilities

  • Design and manufacture IVDs in accordance with requirements of the regulation
  • Create and maintain a risk management file (ISO14971)
  • Complete performance evaluation
  • Compilation and maintenance of technical documentation and EU declaration of conformity
  • Maintain an effective Quality Management System and undergo a conformity assessment (ISO13485) process
  • Assign unique device identifiers (UDI) to applicable products and ensure all packaging and IFU requirements are met

Virtual manufacturers (formerly own brand labelling) who use third party providers to design and manufacture their products must now accept additional legal responsibility for the creation and maintenance of the product technical documentation and declaration of conformity. They must also maintain these documents within a quality management system which is subject to conformity assessment by a notified body.

Where the manufacturer is located in a third country outside the EU, they must appoint an Authorised Representative to act on their behalf within the EU for devices placed on the market.

Note: The requirement to establish an EU Authorised Representative may be applicable to UK manufacturers in the event of a ‘no deal’ Brexit arrangement.

Summary of key responsibilities of an Authorised Representative

  • Ensure technical documentation and conformity assessment is completed by the manufacturer
  • Hold current versions of the technical documentation and declaration of conformity
  • Adhere to all product registration obligations
  • Adhere to vigilance reporting obligations within the EU on behalf of the manufacturer

Both manufacturers and authorised representatives are required to appoint a person responsible for regulatory compliance, this person, or people, must have enough experience to assess the compliance of the device before being placed on the market. This includes reviewing the technical documentation and post market surveillance activities against the requirements of the manufacturers quality management system. The responsible persons are also responsible for the reporting and commination to the competent authorities of any vigilance activities related to the device within the EU.

Summary of key responsibilities of an importer

  • Ensure that the device is in conformity to the regulation
  • Ensure that the device is CE marked and registered (in Eudamed)
  • Ensures that a declaration of conformity is available
  • Checks that if an authorised representative is required, in appointed by the manufacturer and included within the packaging
  • The device meets all labelling requirement of the regulation including IFU and assignment of a UDI
  • Ensures that the packaging includes the importer name and address
  • Maintains and monitors stability of the product throughout transport and storage
  • Maintain and provide complaint and non-conformance data to the manufacturer

The importer is the first point of landing for devices that are manufactured in a third country. It is therefore important that the importer ensures that the products being received meet all the requirements of the regulation prior to distribution. The importer must be recognised within the packaging (IFU or label) and must have a process to collect, store and provide customer feedback to the manufacture as part of post market surveillance.

Summary of key responsibilities of a distributor

  • Ensures that the device is CE marked and declaration of conformity is available
  • Device is accompanied by an IFU
  • Importer name and address is on the packaging
  • A UDI is assigned

Distributors must establish a suitable sampling method to check that the incoming devices meet all the regulatory requirements. They must also maintain records of any customer feedback and provide it to the manufacturer.

If you are any of the above within the IVD market then it would be beneficial to talk to your suppliers/customers to ensure that the responsibilities for each are defined.

IVDeology Ltd can help IVD and Medical Device Manufacturers, Authorised Representatives, Importer and Distributors make an assessment of the responsibilities and provide support for all aspects of quality and regulatory compliance.

Please contact either Stuart or Nancy to find out more:

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