The changeable regulatory environment for Medical Devices and In vitro Diagnostic medical devices (IVD) is showing no sign of slowing down as we begin 2025.
May 2025 – Certificates issued in accordance with IVD Directive (98/79/EC) Annex VI which shall become void at the latest on 27 May 2025 and can not be used for placing CE marked IVDs on the Great British Market.
June 2025 – Development of draft guidance on artificial intelligence (AI) development and deployment
Winter 2025 – Statutory Instrument on Pre-Market Requirements
With so much change happening, it has never been so important to engage with your regulatory teams, to understand the impact and implications of the changes and to get ahead of the game. IVDeology work with IVD manufacturers throughout the global industry to Educate, Evaluate and Execute regulatory strategies to Sustain market access.
You can get in touch with IVDeology by booking time with our friendly team here or email i[email protected] – we’d be happy to chat
We also have a series of online webinars that can also support your next steps and understanding of the regulatory landscape, you can check the early 2025 sessions here:
“The government has committed up to £520 million for life sciences manufacturing, to help deliver on the government’s missions to kickstart economic growth and build an NHS fit for the future.
The LSIMF will be UK and sector wide and will provide capital grants for investments in the manufacture of:
Human medicines (this includes both the manufacture of active pharmaceutical ingredients (API) / drug substance and finished product / drug product).
Medical diagnostics – for both disease identification and monitoring.
MedTech products – all types of medical devices related to human health.”
This new initiative could offer an opportunity to grow an SME diagnostic company to enhance their manufacturing capabilities.
“To be eligible for the fund, your project must:
Have a total cost (capital and non-capital costs) of at least £8 million
Be located in the UK
Be primarily a capital investment
Be a single company investment (as opposed to forming a partnership between companies or other types of organisations)
Require only the amount of grant requested to proceed. For example, without the specific amount of funding you are requesting your project wouldn’t go ahead or go ahead at a smaller scale, go ahead overseas or would be significantly delayed (3 years or more)
Be a manufacturing project for the manufacture of:
Human medicines (this includes both the manufacture of active pharmaceutical ingredients (API) / drug substance and finished product / drug product).
Medical diagnostics – for both disease identification and monitoring
MedTech products – all types of medical devices related to human health.
The fund is open to applications for both MHRA-licenced products and products in development where a MHRA licence is intended to be sought for commercial scale-up, for example a manufacturing project for clinical trials.
Manufacturing facilities are required to work to Good Manufacturing Practice (GMP) and the facility be intended to support clinical and/or commercial manufacture of API or drug product.
Manufacturers of medicinal diagnostics and medical devices must confirm that their device meets or intends to meet the requirements of the Medical Devices Regulations 2002.”
The reference to the requirement to meet, or plan to meet the Medical Device Regulations 2002. Currently this would require device manufacturers to understand and comply with the current UK regulations, and potentially any new updates relating to UKCA. It would be interested to learn what level of regulatory understanding the manufacturers are required to have and demonstrate as part of the application.
For ideas on building an effective regulatory strategy, find out more in our recent blog: ‘Regulatory Strategy: What is it, and why do I need one?’
You can reach out to us at [email protected] or you can book straight into our diary at a time suitable for you here
The Potential of Artificial Intelligence in Healthcare
Artificial Intelligence (AI) in healthcare has the potential to improve patient outcomes, for example, by improving diagnosis or treatment selection. However, it is difficult to assess new and innovative AI technology using traditional trial techniques.
The AI Airlock
In Oct 2023, the Medicines and Healthcare products Regulatory Agency (MHRA) announced that they would set up a regulatory sandbox, the AI Airlock. This will provide software and AI medical device developers with virtual testing environments in which they can design and implement test protocols for their devices. There will be three different testing environments (Simulation airlock, Virtual airlock and Real-world airlock) and different factors will determine which testing environment will be most appropriate to each candidate and their device. MHRA’s AI Airlock webinar, presented in July 2024, provides more details about the AI Airlock.
By bringing together expertise from innovators, regulatory organisations including Approved Bodies, Government, the NHS and academia, the AI Airlock pilot program will allow for a collaborative approach. This will enable developers to generate robust evidence for their technology and assist in safe development and deployment of such devices.
Devices will need to meet one or more of the following eligibility criteria:
Has the potential to deliver benefits for patients
Device or concept application is innovative
Presents a regulatory challenge
Device is conceptually/developmental robust and ready to be trialled.
Four to six candidates will be recruited to join the pilot cohort and there is no fee for application or participation in the pilot program. Candidates will need to commit resource to the pilot program and are expected to fund their own studies and delivery of any Airlock testing, including accessing relevant data sets. Whilst this pilot phase of the AI Airlock will run until April 2025, candidates should expect to complete their individual Airlock testing within 6 months.
Learnings from this first pilot programme will inform future Airlock phases and the outputs will include:
Project Reports from each candidate project team,
An Airlock Sandbox report of learnings to inform future guidance and implications for the regulatory framework,
A programme evaluation report sharing learnings on the use of regulatory sandboxes.
Application to the MHRA
This is a great chance for software and AI medical device developers to obtain advice from regulators whilst they experiment and testing their device in controlled and safe environments. Participation in the programme also offers developers an opportunity to have a part in informing the future GB regulatory framework on software and AI medical devices.
The Medical Device Single Audit Programme (MDSAP) is a system by which the participant competent authorities to recognise the quality management certification (as awarded after audit against both ISO 13485 and county specific requirements) from a single authority for medical device and in-vitro diagnostic medical device (IVDs) legal manufacturers.
The programme has been established by the International Medical Device Regulators Forum (IMDRF) and is intended to provide a harmonised approach to demonstrating the compliance of the Quality Management System (QMS) using a globally recognised approach.
The MDSAP was developed by the IMDRF to:
Enable appropriate regulatory oversight of medical device manufacturers’ quality management systems while minimizing regulatory burden on industry;
Promote more efficient and flexible use of regulatory resources through work sharing and mutual acceptance among regulators while respecting the sovereignty of each authority;
Promote globally, in the longer term, a greater alignment of regulatory approaches and technical requirements based on international standards and best practices;
Promote consistency, predictability and transparency of regulatory programs by standardizing;
1. the practices and procedures of participating regulators for the oversight of third party auditing organizations, and 2. the practices and procedures of participating third party auditing organizations
Regulatory Authorities
MDSAP consists of Regulatory Authority Council Members, Observers and Affiliate members:
Regulatory Authority Council Members:
Therapeutic Goods Administration of Australia
Brazil’s Agência Nacional de Vigilância Sanitária
Health Canada
Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency
U.S. Food and Drug Administration
The RAC is the decision-making body of MDSAP and consists of representatives from all regulatory authorities that are members of the RAC. The RAC provides direction, oversight, and resources to support the MDSAP development, implementation, maintenance, and expansion.
Observer Members:
European Union (EU)
Singapore’s Health Sciences Authority (HSA) (NEW)
United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA)
The World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Programme
The observers do not observe RAC members and do not attend RAC meetings, but they do observe and contribute the RAC activities. Both the EU and UK have been Observers for over 2 years, and as such, can apply to become full RAC members if desired.
Affiliate Members:
Argentina’s National Administration of Drugs, Foods and Medical Devices (ANMAT)
Ministry of Health of Israel
Kenya’s Pharmacy and Poisons Board (New member)
Republic of Korea’s Ministry of Food and Drug Safety
Federal Commission for Protection from Sanitary Risks (COFEPRIS) of Mexico
TFDA – Taiwan Food and Drug Administration
Affiliate members are not members of the RAC or an Official Observer, but engages in MDSAP, demonstrates understanding of MDSAP and utilizes MDSAP audit reports and MDSAP certificates for evaluating compliance with applicable medical device requirements, including a manufacturer’s quality management system, under the Affiliate Member’s regulatory framework.
The application of the MDSAP Programme
The utilisation of the MDSAP programme, and the resulting certificates are utilised differently depending on each Competent Authority as dedicated by each regional requirement.
Regulatory Authority
Utilisation of MDSAP
Australia
MDSAP audit report is used as part of the evidence that it has assessed for compliance with medical device market authorization requirements, unless excluded or exempt from these requirements.
Brazil
ANVISA utilizes the outcomes of the program as part of the pre-market and post market assessment.
Canada
Manufacturers intending to place a product on the market in Canada must have an MDSAP Certification issued by an Auditing Organization.
Japan
The Ministry of Health, Labour and Welfare (MHLW) and Pharmaceutical and Medical Devices Agency (PMDA) utilize these audit reports in pre-market and post-market audits.
United States
U.S. FDA will accept the MDSAP audit reports as a substitute for FDA routine inspections under a 510(k) device application. The use of MDSAP is not utilised for pre-approval or post-approval inspections for Pre-Market Approval (PMA) applications.
The regulations for the above Regulatory Authorities are available (English) from the USA FDA Website.
The use of the MDSAP programme and certification will be greater utilised as he programme expands and more regulatory authorities recognise the value in this process.
The MDSAP Audit Cycle and Auditing Organisations
Auditing Organisation are certification bodies that have successfully applied, and been recognised by the MDSAP programme to audit medical device manufacturers against the requirements of the MDSAP programme. The current list includes many European Notified Bodies (under EU IVDR), and UK Approved Bodies (under UKCA) and are globally recognised.
The MDSAP audit is typically build on to the existing ISO 13485 certification audit of the Quality Management System with a 3-year audit cycle.
Figure 1 MDSAP Certification Cycle
Will MDSAP come to the EU and UK?
There is much talk regarding the use of MDSAP by the EU and UK. While I am a strong advocate in global harmonisation, the existing members joined MDSAP to find a harmonised way to create a robust process for standardising QMS requirements from a position where they needed to find a suitable and robust process. Regardless of the state of play in the EU and UK, both regions already have robust mechanisms for the surveillance of ISO 13485, largely provided by the technical and commercial expertise of EU and UK Notified Bodies and Approved Bodies (as part of ISO13485 certification/IVDR conformity assessment), so the utilising MDSAP would be less impactful.
The opportunity would be regarding the outward facing regulatory convergence of EU and UK to align, and reduce burden for accessing other markets, MDSAP would be a good way of doing this. We have seen TGA become well placed in MDSAP/IMDRF mainly utilising CE marking for supporting AUS market access.
The challenge with MDSAP is that each jurisdiction has specific requirements, which make the MDSAP process clunky. The key to an improved model is to remove local requirements as much as possible, however this is dependent on global alignment at a political as well as regulatory level.
If you’d like to discuss MDSAP with us, you can book a call with the IVDeology team as we navigate this new programme and what it means for you as a manufacturer or provider of IVD’s and devices with each of the individual requirements. Being part of BIVDA (British In Vitro Diagnostics association), we’re in a great position to be able to receive and understand information and distribute to our networks as it comes, in a reliable and digestible way.
Or if you’d like support in other areas of Quality assurance or regulatory compliance, we’d be happy to chat with you. We can support with Quality management system implementation, transfer or uplifting.
We’ll be keeping you up to date with MDSAP news on our LinkedIn page and website, so do follow up on our socials and keep up to date with IVDeology along with Abingdon Health PLC.
Written by Stuart Angell, MD and Co-founder of IVDeology and IVDeology UKRP
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.
The MHRA held a webinar on March 5th to give an insight into the plans for the future UK regulations for medical devices and IVDs.
The key points for IVDs they made are:
· The definition of IVD will be extended to mirror the definition in the IVDR.
· Devices will be classified into 4 groups, A-D, using a risk based approach. Device classification will follow the IMDRF guidance N64 document – Principles of In Vitro Diagnostic (IVD) Medical Devices Classification, with a couple of UK specifics:
o Devices which monitor infectious loads of life-threatening infectious diseases will be classified as Class D
o Devices with the intended purpose for screening, detecting or diagnosing either neurodegenerative diseases or cardio vascular diseases will be classified as Class C.
Accessories, Independent Software and Companion diagnostics will be classified in their own right. Software that drives a device, calibrators and controls will be classified in the same group as the associated device.
· The Essential Requirements will be updated to generally align with the GSPR under IVDR with differences to reflect the UK specific legislation & national bodies.
o This includes alignment for the requirements for labelling and instructions for use.
The take home message we took away was that they are trying to harmonise with the IMDRF model and the EU IVDR wherever possible to try and reduce the burden on manufacturers whilst still ensuring that the devices on the GB market are safe and effective for users and patients.
Whilst this is good news for manufacturers as a whole and for many they may see very little difference between the UK and EU regulations. However for other manufacturers their devices may end up being classified differently in each regulation. What potential challenges may these differences in classification cause?
As the essential requirements will align, the impact for the technical file will hopefully be minimal. And following the IMDRF model may have advantages too – aligning with other key markets such as Canada and Australia. However differing classifications may have an impact on Post Market Surveillance and whether a PMS report or a Periodic Safety Update Report is required. It may also give notified bodies/UK approved bodies more work as they will have to consider how the differences in classification impact their role. What may the impact on market access be if we diverge from the EU when we know our market are closely linked? We would love to hear some thoughts.
Written by Fiona Thompson – RA specialist at IVDeology
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