Tag: lateral flow

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A review of the MHRA Fee Consultation

Executive Summary

The MHRA (Medicines and Healthcare products Regulatory Agency) held a public consultation on proposed amendments to its statutory fees, to ensure ongoing cost recovery. The consultation ran from August 29, 2024, to October 24, 2024. The majority of respondents (including stakeholders, from UK Approved Bodies, Trade Associations, Manufactures and the public) disagreed with the new medical devices registration fee, hence the MHRA have decided to proceed with the wider fees uplift and continue exploring options for this fee. The implementation date for the proposed changes to the wider fees uplift is early Q1 2025/26.

Introduction

The MHRA regulates medicines, medical devices, and blood components for transfusion in the UK. It operates on a full cost-recovery basis, ensuring financial sustainability and service delivery. Fees are updated regularly to reflect the cost of regulatory activities, including staff costs and corporate overheads. The MHRA, as a department of the UK government, need to be self-sustaining financially. Any activity they perform, and they are critical to the monitoring of medicines, medical devices and IVDs on the UK market, needs to be paid for by cost recovery initiatives, such as those summarised in the consultation document.

Evaluation of Responses

The document evaluates responses to the five proposals:

  1. Proposal 1: Increase statutory fees to ensure continued cost recovery. Most respondents did not agree, citing high costs and impact on SMEs, particularly in the case of the new proposed medical devices registration fee. The MHRA plans to proceed with the wider fees uplift but did refer to existing payment easements for small companies and payment waivers for SMEs for certain fees. However, this does not apply to medical devices or IVDs.
  2. Proposal 2: Amend the Medical Device Registration fee to include post-market work costs. Most respondents disagreed, citing financial burden on businesses, especially SMEs. The MHRA will continue exploring options for this fee and in the meantime, the existing one-off medical devices registration fee will remain but get the indexation increase being applied to all other existing fees (i.e. raising it from £240 to £261).
  3. Proposal 3: Create a new service for regulatory advice meetings for medical devices. Most respondents agreed, but requested more details on scope, format, and timelines. Questions were also raised with regards to the MHRA’s advice versus that of Notified/Approved Bodies, and the risks if advice was contradictory. The MHRA plans to proceed with this proposal.
  4. Proposal 4: Amend fee models for existing services and remove obsolete fees. Most respondents did not have an opinion but agreed in principle and requested more information be provided. The MHRA plans to proceed with this proposal.
  5. Proposal 5: Update the legal definition of a “standard variation” application for homeopathic products. Most respondents did not have an opinion, and the MHRA plans to proceed with this proposal.

Unintended Impacts on Protected Characteristics

The MHRA assessed the proposals for potential unintended discrimination. Most respondents did not have an opinion, but some raised concerns about the impact on product availability for rare conditions and minority groups. The MHRA believes the risk of unintended discrimination is low.

The implementation of this proposal will also see an increase to UK Approved Body fees, which will increase the financial burden on anyone who potentially uses the international recognition route or UKCA marking for classes B, C and D.

The biggest challenge for IVD manufacturers was the proposal to change how fees were applied for device registrations (proposal 2). In the consultation, a change of fees from £240 (one-off fee) to £210 per GMDN code registration (annually) was originally proposed. This would substantially increase the year on year costs of maintaining IVDs on the UK market (often at an increase of up to 5,000%) Whist the increase continued to be considered, the existing one-off medical devices registration fee will remain but get the indexation increase being applied to all other existing fees (i.e. raising it from £240 to £261) will occur later this year (exact date unconfirmed).

Closing thoughts

In summary, we understand that cost have to be recovered for the services the MHRA provide, and in reality, the fees for the UK are lower than many key regulatory markets (e.g. USA). However, in an aid to ensuring the UK continues to have early access to world leading and innovative products, the UK needs to be shaped into an attractive destination for IVD manufacturers in the short term. A substantial increase in medical devices fees, disproportionate to market size, would not support this message.

We will continue to engage with our customers on the outcome from the consultation and potential impacts of this change, as well as continue to engage with BIVDA, our trade association, to work with the MHRA to find a positive way forward.

IVDeology provides expert regulatory consultancy for anyone taking advantage of the UK’s current regulatory pathway, or planning for UKCA transition. We can help you build your regulatory strategy to consider the impact of UK international recognition, and support non-UK manufacturers place product on market utilising our UKRP service.

Book a call with us to discuss your regulatory challenges or questions and see how IVDeology can help you.

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BIVDA Member IVDeology excited to Sponsor 2025 IVDR Event

IVDeology are excited to announce our first sponsorship of a BIVDA event, the 2025 annual 2-day IVDR Seminar hosted in Birmingham, UK! The event runs the 11th & 12th of February in person.

The ‘British in vitro Diagnostics Association’ (BIVDA) was formed in 1992 and operates from offices in central London. BIVDA is the national association for the IVD industry, including distributors and manufacturers, representing 97% of the market and nearly 250 organisations, with new members joining regularly.

IVDeology have been members of BIVDA for several years, as well as our Co-founder and MD Stuart Angell chairing the Regulatory Affairs working party. BIVDA has been an integral and very important part of IVDeology, allowing the networking and opportunity to collaborate with other IVD professionals, from consultants to Notified Body members, to business owners and others alike.

Being a British IVD consultancy and support team, we knew BIVDA would be the ideal membership for IVDeology, connecting us with specialists in the industry and keeping up to date with legislations and regulations. Membership allows IVDeology access to a board of expert members looking to shape and navigate the regulatory landscape.

And that is a big part of IVDeology and our journey too! Helping our customers navigate the ever-changing regulatory landscape, but helping you learn along the way.

We love being part of a voice for the British diagnostics industry, and our goal is to support those wanting to change and improve lives of patients. So, we are excited to not only be attending the BIVDA Regulatory affairs seminar once again but sponsoring the event too!

What can you expect during the 2 day seminar?

Members will be attend sessions providing detailed and expert opinion and guidance on regulatory topics, with key speakers from the field including:

  • Strategy plan and update for 2025 from BIVDA for it’s members
  • Key note speakers and panel discussions from IVD expert specialists with time for Q&A
  • Recap of 2024 and looking at 2025 activity for the UK IVD industry and what to expect
  • Workshops and break out sessions regarding hot industry topics
  • … and much, more more!

We have several of our IVDeology members attending the event and would be more than happy to chat with you about all things IVD! So please look out for us.

And if you have any questions about becoming a BIVDA member or registering for the event, you can reach out to us at [email protected], or directly to BIVDA at [email protected] or register for tickets at Annual Regulatory Affairs Seminar (2 Day event) Tickets, Tue 11 Feb 2025 at 10:00 | Eventbrite

Or if you’d like to discuss any regulatory compliance support, you can book right in with us via this link to speak to our friendly team

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Performance Evaluation: The critical component in bringing your product to market and keeping it there

Abingdon Health and IVDeology Ltd have decades of  In-Vitro Diagnostic (IVD) regulatory compliance experience where our teams support your entire product journey from ‘cradle-to-grave’ to ensure you are getting your product to market in the quickest timeframe possible, reducing cost and strain, and keeping it compliant through its lifetime.

Abingdon Health also offer full-service contract development and manufacturing for lateral flow assays, bringing your idea to commercial success, with the benefit of an integrated regulatory and quality approach.

In our latest blog, Candice Vendettuoli Head of RAQA at Abingdon Health covers the importance of getting your Performance Evaluation (PE) right to streamline your route to market, and ensuring compliance to keep it there.

What is Performance Evaluation?

The In Vitro Diagnostic Regulation (IVDR) 2017/746, which entered into force in May 2017 and applied in May 2022, has introduced significant changes to the way in vitro diagnostic (IVD) medical devices are regulated in the European Union. One of the key aspects of this regulation are the new requirements for documenting the performance evaluation of IVD medical devices using a prescriptive document structure mandated within the Regulation.

Performance evaluation under IVDR is expected to be a continuous process throughout its entire lifecycle of the device. This process is crucial for ensuring that the device meets upon entry to the market, and continues to meet, the intended clinical benefits and safety as claimed by the manufacturer.

The mandated documents should be written to provide a comprehensive and structured narrative for the reviewer giving a clear and logical explanation of how the device was developed, verified and validated against the intended use/purpose claimed by the manufacturer. These documents are a requirement of the Technial Documentation described in Annex II and forms an essential part of the submission to the Notified Body

The mandated documents, unless they can justify why such studies are not applicable are as follows:

Performance Evaluation Plan

Ideally written during the early development of the device and updated regularly, this document has content prescribed within Annex XIII section 1.1 of the Regulation. Manufacturers are required to establish and regularly update the performance evaluation plan that outlines the device’s characteristics and performance, as well as the process and criteria used to generate the necessary clinical evidence.

Scientific Validity

The concept of scientific validity under the In Vitro Diagnostic Regulation (IVDR) 2017/746 is a cornerstone in the performance evaluation of in vitro diagnostic (IVD) medical devices. It refers to the association of an analyte with a clinical condition or physiological state, which must be substantiated with a medical-scientific rationale evidenced through a systematic literature search

Analytical Performance

Analytical performance refers to a device’s ability to accurately and reproducibly measure an analyte, marker, or molecule, which is a strictly technical performance without the need for correlation with a targeted pathology.  There are analytical performance characteristics mandated within Annex I section 9.1(a) including assessing the accuracy, sensitivity and specificity,

Clinical Performance

Clinical performance is defined as the ability of a device to yield results that are correlated with a particular clinical condition, physiological or pathological process, or target population and intended user. Manufacturers must demonstrate clinical performance through one or more of the following:

  • Clinical performance studies, carried out according to the IVDR requirements on clinical performance studies described in Articles 57-77, Annex XIII section 2 and, if applicable, Annex XIV for studies other than those using leftover samples
  • Scientific peer-reviewed literature on the device under evaluation, or
  • Published routine diagnostic testing.

Performance Evaluation Report

The report (also known as a ‘PER’) provides a summary of the clinical evidence collected through the previous reports. An assessment can then be made against the current state of the art in diagnostics and medicine that a positive benefit-risk ratio of using the device for its intended purpose has been met and then all data has been collected.

This rigorous approach ensures the reliability and effectiveness of in vitro diagnostic devices within the European Union, with the primary aim of protecting public health by requiring high levels of safety and performance of these devices to be evidenced.

For manufacturers, understanding and adhering to the IVDR’s performance evaluation requirements is vital for successful market introduction of their IVDs in the European Market. It involves a comprehensive understanding of the general safety and performance requirements (GSPR), as well as the specific guidelines on performance evaluation stipulated in Article 56 of the IVDR.

Abingdon Health and through its subsidiary IVDeology Ltd , can offer support and guidance to help companies navigate these new and complex EU Performance Evaluation requirements.

We offer a full-service solution for all your regulatory and quality requirements including:

Contact Us today to book some time with one of our industry experts to understand how we can support you bringing your product to market and keeping it there.

 

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Role of the UK Responsible Person and the importance for future regulations

Following on from the Statement of Policy intent on international recognition of medical devices released by the MHRA on 21 May 2024, it is clear that the role of the UK Responsible Person will still be important in the future regulations for the UK.  This will be irrespective of whether devices will be placed on the market under the UKCA mark or using one of the recognition pathways from a comparable regulator country (CRC).

A UK Responsible Person (UKRP) is “a person established in the United Kingdom who acts on behalf of a manufacturer established outside the United Kingdom in relation to specified tasks with regard to the manufacturer’s obligations under these regulations.”

There has been a requirement for non-UK medical device & IVD manufacturers to appoint a UKRP in order to place their devices on the Great Britain (England, Wales & Scotland) market since the beginning of 2021. 

A letter of designation must be created and signed by both the manufacturer and the UKRP to officially appoint the UKRP to act on behalf of the manufacturer.  This letter is required to be uploaded as part of the registration process with the MHRA.

The UKRP responsibilities include:

  • ensuring that the declaration of conformity and technical documentation are correct and available if required by the MHRA
  • register the manufacturer, device and any importers with the MHRA
  • liaise with the MHRA for any requests of documentation, samples of devices and with regards to any preventative or corrective actions
  • inform the manufacturer of any complaints or any incidents related to the device
  • terminate the agreement and inform the MHRA if the manufacturer does not comply with the regulations

Selecting your UK Responsible Person should take careful consideration.  It is important that manufacturers appoint someone with the right experience to help with this process.  The manufacturer needs to be confident that the UKRP will be fulfilling their obligations on the manufacturer’s behalf and consequently the UKRP should be considered a critical supplier.  It is important that the manufacturer is assured that if there is a vigilance case identified on the Great Britain market, 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 Great Britain market. 

This especially will become more important as the new regulations come into effect.  The government responses to the consultation on the future regulations released in June 2022 indicates that a “Qualified Person” would be required to be permanently and continuously at the disposal of a UKRP.  This “Qualified Person” would need to meet minimum qualifications and/or regulatory experience in the field of medical devices or IVDs. This role is expected to be similar to the Person Responsible for Regulatory Compliance (PRRC) for the IVD Regulation and therefore it will be important for manufacturers to ensure that the selected UKRP can fulfil this requirement.  The UKRP name will also need to be included on the label, although this may be via over-labelling and the MHRA are also investigating the possibilities around digital labelling.

At IVDeology we offer a UK Responsible Person service.  We currently have a number of different customers from across Europe and the US and between them we have registered 489 products with the MHRA to date.

Our onboarding process involves the appropriate contract and letter of designation, followed by a technical review of the devices to be registered by one of our team.  Once confident that everything is in place, the manufacturer and devices are registered with the MHRA.  The process can and has been completed very quickly when a complete technical file has been provided to us for review.

One of the biggest challenges we have faced is around GMDN codes.  The MHRA registration process utilises GMDN codes to register the devices.  Often this has not been considered by manufacturers or the selected codes haven’t been reviewed to ensure that they are still current and appropriate for the device in question.  This can often lead to a delay in being able to register and ultimately placing the device on the UK market.

As a UKRP, we also provide Post Market Surveillance reports for our customers annually and keep them updated with any new relevant information released from the MHRA on future regulations.  This will be more important as the Post Market Surveillance is implemented and also to ensure that our UKRP customers continue to meet the changing regulatory requirements for the UK.

In summary, to place medical devices or IVD’s on the Great Britain market, there is already an established requirement to have a UK Responsible Person.  Whilst currently there are limited restrictions on who this person can be other than they have to be based in the UK and many manufacturers have enlisted their distributor or a UK office to fulfil this role, moving forward it will be more important to ensure that the UKRP that you have selected has the right level of expertise and experience to help support you place your device on the Great Britain market.

You can find out more about our UK Responsible Service here or book a call with one of our team.

Written by Regulatory Specialist Fiona Thompson, IVDeology Ltd and IVDeology UKRP