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:
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.
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 [email protected]
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
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.
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.
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 www.ivdeology.co.uk, 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!
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
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: [email protected]
Risk is something we deal with all day, every day in our busy lives. Sitting down with my breakfast writing this I had to boil water in my kettle, carry hot coffee to my desk in a mug, toast some bread in my toaster, retrieve butter from my electric fridge…
Risk is everywhere, but did I worry about burning myself on the hot water? or electric shock from my toaster? No, because I am confident that the equipment that I used was safe to use. The products are CE marked, and I have confidence that the manufacturer has demonstrated that the kettle, or toaster are safe and effective for their intended use.
For medical devices, and in-vitro diagnostics, this responsibility of the manufacturer is the same, so that people like me (for a self-test, or a trained person for a lab or near patient test) have confidence that the device is safe and effective to use. The current state of the art for assessing risks for medical devices is the international harmonised standard ISO 14971:2012; Medical devices – Application of risk management to medical devices and it provides a backbone for an effective quality management system (demonstrated by the increased reference within ISO13485:2016 and MDSAP) and a core part of the General Safety and Performance Requirements of the MDR and IVDR.
SO14971:2012 provides a systematic approach to ensure that all risks associated with the design, manufacturing & delivery and use of the device are identified, considered and controlled as far as possible. Not only is this assessment performed as part of design and development of the device and continuously reviewed throughout the product life-cycle.
“Risk assessment is part of design and development of the device
and continuously reviewed throughout the product life-cycle.”
The standard provides very good guidance on how to construct and manage a risk management system. It also includes a series of informative Annex notes giving further details and examples on the risk management process and tools that could be used.
A common tool for risk assessment is an FMEA (failure mode and effects analysis) which focuses on the potential (or actual) failure modes resulting from a design or process step associated with a device.
The FMEA tool is very useful for initial brainstorming of risks, contributing factors and upstream impacts as you design your product or your manufacturing process. The IVDeology template uses the quantitative estimation of severity of harm (SEV), occurrence or harm (OCC) or ability to detect failure (DET) each with a score from 1 (low) to 10 (high). In practice the rating can be difficult to estimate during early design stages therefore the risk assessment should be reviewed at each stage of the product life-cycle. The severity, occurrence and detection values multiplied together result in a Risk Profile Number (RPN) from 1 to 1000. The higher the number the greater risk and therefore greater consideration should be given to implement mitigating controls, however all risks should be evaluated to identify opportunities to reduce risks.
Risk should be lowered as far as possible by implementing additional controls into the design of the product, design and control of the production process (including in-process testing) to ensure the inherent safe design and construction of the device.
Note: Provision of additional warnings given to the user within the information of use (IFU) should not be considered a risk reduction strategy.
“Risks should be lowered as far as possible by design changes
or design or control of the production processes. Additional warnings
in the IFU should not be considered for a risk reduction strategy”
For each design change or process improvement (risk reduction) identified within the FMEA template, suitable methods of verification or validation should be described or referenced. This ties in Risk Management to product verification and validation mechanisms (and supply control) essential for ISO13485:2016.
When all risks have been mitigated to as low as possible, each residual should be reviewed with respect to the benefit of the device given the intended use and intended purpose defined by the manufacturer. If the risk is low then the risk-benefit of he device can be easily justified, however if the residual risks continue to be high then the risks could outweigh the benefit and further controls should be considered.
For effective risk-benefit evaluation the manufacturer must gain a full understanding of the intended use and intended purpose of the device (how, why, when, what its used for and who by) and what the implications (clinical benefit) are when a result is obtained. This information should be continuously reviewed when the product is placed on the market using suitable post-market activity e.g. customer feedback & complaints, literature reviews, post market performance studies.
“Integration of Risk Management into the QMS will not only reduce the burden
of Risk Management file maintenance but actively support design control,
change management, vigilance reporting, supplier management and CAPA”
An effective Risk Management file which is fully implemented and maintained can be a highly useful tool in other parts of a quality management system. Below are some examples of potential interactions with the QMS:
Design Control – Early risk assessment of design characteristics using a design FMEA, together with an understanding on the intended use and intended purpose of the device can shape your design process based on the risk of the products including the extent of verification and validation mechanisms
Production Development – Evaluation of risks associated with process steps, equipment or materials used can reveal the areas of highest risk to product safety and performance. These ‘hot spots’ should have more stringent in-process checks, higher sampling rates or functional in-process tests compared to less critical areas of the process.
Change Management – Any potential changes to the device design or production process can be reviewed against the risk management file. The impact of the change can be included into the risk assessment (FMEA) to ensure that it does not have any adverse impact on safety or performance. In addition, the level of change verification or validation can be justified according to the risk profile (RPN) of the change.
Supplier Management – The selection and control of suppliers can be determined by the impact on the safety and performance of the product using the risk assessment process. Critical suppliers, where there is the biggest risk to product should have greater controls in place.
CAPA and Vigilance Reporting – Evaluation of potential or actual failure modes within the risk assessment (FMEA) will provide a good starting point to determine the risk on product (and customer, user or patient) when potentially reportable events occur. This can be very useful when time restrictions require clear, objective decisions. In addition, an active risk assessment process can provide guidance on the most likely causes of failure (contributing factors) to focus on during root cause investigations.
The overall result in a well-established risk management process is the ability of the manufacturer of a device to determine with a degree of confidence that the product it places on market is safe and effective for use and meets the requirements of the IVD regulations so that when the user sees the CE mark, they are confident in the devices safety and performance.
Do you have further questions? We can help! IVDeology Ltd provide expert solutions for medical device companies in quality and regulatory affairs. Contact us at [email protected] or visit us at www.ivdeology.co.uk
