“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 Global Medical Device Nomenclature (GMDN) system plays a crucial role in the regulatory landscape for in vitro diagnostic (IVD) medical devices. In Australia, the Therapeutic Goods Administration (TGA) mandates the use of GMDN codes for the registration of IVDs. This blog explores the significance of GMDN codes, their application in TGA device registration, and the benefits they offer to manufacturers and regulators alike.
The use of GMDN codes is essential for several reasons:
Consistency and Clarity: GMDN codes provide a consistent and clear way to describe medical devices, reducing ambiguity and ensuring that all stakeholders have a common understanding of the device’s characteristics.
The utilisation of GMDN codes is a critical component of the regulatory framework for IVDs in Australia. By providing a standardized system for identifying and classifying medical devices, GMDN codes help ensure regulatory compliance, enhance traceability, and facilitate global harmonization. For manufacturers, understanding and effectively using GMDN codes is essential for successfully navigating the TGA device registration process and bringing safe and effective IVDs to market.
By embracing the use of GMDN codes, manufacturers can streamline their regulatory processes, improve market access, and contribute to a safer and more transparent healthcare system. As the regulatory landscape continues to evolve, the importance of GMDN codes in ensuring the safety and efficacy of medical devices will only continue to grow.
If you’d like friendly compliance advise then please don’t hesitate to reach out to us at [email protected] or book in with our team at a time that suits you for a teams call by clicking here, and make sure to follow up on LinkedIn to be notified with IVD industry news and updated
In the realm of In-vitro diagnostic Medical devices, regulatory compliance is non-negotiable. The European Union In Vitro Diagnostic Regulation (IVDR) have set stringent standards to ensure the safety and efficiency of medical devices. A pivotal role introduced by these regulations is the Person Responsible for Regulatory Compliance (PRRC). The PRRC is tasked with ensuring that all regulatory requirements are met, from product development through to post-market surveillance. This role is essential for maintaining the quality and safety of medical devices, and compliance with these regulations is mandatory for companies operating within the EU.
However, for many companies, especially small to medium-sized enterprises (SMEs), the challenges associated with maintaining an in-house PRRC can be daunting. This is where outsourcing the PRRC role comes into play. Article 15 of the IVDR allows the utilisation of external PRRCs for micro and small enterprises. IVDeology have a proven track record in providing expert regulatory expertise to SMEs.
One of the most significant benefits of outsourcing the PRRC role is the access to specialized expertise. Regulatory compliance is a complex and ever-evolving field, requiring a deep understanding of both the regulations and the specific products being developed. Outsourcing to a third-party provider ensures that the PRRC has the necessary experience and knowledge to navigate these complexities. These experts are typically well-versed in the intricacies of the IVDR, and they stay abreast of the latest developments in the regulatory landscape. This level of expertise can be particularly advantageous for companies developing innovative or highly specialized products, as it ensures that all regulatory requirements are met to the highest standards.
Saving Time and Money in the Long Run
Hiring and training an in-house PRRC can be a costly endeavour. The recruitment process itself can be expensive, and once a suitable candidate is found, they need to be trained and continuously educated on the latest regulatory requirements. Additionally, the salary for an experienced PRRC can be substantial. By outsourcing this role, companies can reduce these costs significantly. Third-party providers typically offer their services on a contract basis, which can be more cost-effective than employing a full-time, in-house PRRC. This approach allows companies to allocate their financial resources more efficiently, investing in other critical areas of their business such as research and development, marketing, or expanding their product portfolio.
Our aim is to work with our clients to develop a succession plan for the eventual internal replacement of our virtual PRRC. We will train and mentor the identified internal team members so build the experience required to meet the requirements of Article 15.
Letting Experts Handle Compliance
Regulatory compliance, while essential, is often not a company’s core activity. For many organizations, particularly SMEs, the primary focus is on developing innovative products, enhancing customer experiences, and growing their business. We understand that some organisations may not want to build their regulatory team internally, so we always try to build long term relationships with our customers for continuous support. By outsourcing the PRRC role, companies can allow their internal teams to focus on these core activities. This not only enhances productivity but also ensures that the regulatory compliance function is handled by experts. This separation of duties can lead to better outcomes in both regulatory compliance and overall business performance.
“Regulatory compliance is the responsibility of everyone in the organisation, the PRRCs core responsibility is to observe, reflect and advise on the overall compliance state of the organisation to senior management”
Adapting to Changing Needs
The regulatory landscape is constantly changing, and the demands placed on the PRRC can vary significantly over time. Outsourcing the PRRC role offers companies the flexibility to scale their regulatory compliance efforts up or down as needed. For instance, during periods of intensive product development or regulatory scrutiny, a company may require more comprehensive compliance support. Conversely, during quieter periods, the level of support needed may be reduced. Outsourcing allows companies to adapt to these changing needs without the long-term commitments associated with employing a full-time, in-house PRRC. This flexibility can be particularly beneficial for companies with fluctuating workloads or those operating in highly dynamic industries.
Ensuring Compliance and Avoiding Penalties
Non-compliance with regulatory requirements can result in severe penalties, including fines, product recalls, and even the suspension of business operations. The PRRC plays a crucial role in mitigating these risks by ensuring that all regulatory requirements are met and that any potential issues are addressed promptly. Outsourcing the PRRC role to a reputable third-party provider can enhance this risk mitigation process. These providers have the experience and resources to conduct thorough compliance assessments, implement robust quality management systems, and respond swiftly to any regulatory changes or issues. This proactive approach can help companies avoid the costly consequences of non-compliance and maintain their reputation in the market.
Staying Ahead of Regulatory Changes
The IVD industry is characterized by rapid technological advancements and frequent regulatory updates. Staying ahead of these changes is critical for maintaining compliance and achieving business success. Outsourcing the PRRC role to a third-party provider ensures that companies have access to the latest regulatory knowledge and best practices. These providers invest in continuous education and professional development to stay current with regulatory changes. By leveraging their expertise, companies can continuously improve their compliance processes, adapt to new regulations seamlessly, and maintain a competitive edge in the market.
Giving you a Strategic Advantage
Outsourcing the PRRC role offers numerous benefits for companies operating in the medical device industry. From accessing specialized expertise and achieving cost savings to enhancing focus on core activities and adapting to changing needs, outsourcing provides a strategic advantage. By partnering with a reputable third-party provider, companies can ensure that their regulatory compliance efforts are handled by experts, mitigating risks and driving continuous improvement.
In an industry where compliance is critical to success, outsourcing the PRRC role can be a game-changer, allowing companies to navigate the complexities of regulatory requirements with confidence and achieve their business goals.
On the 9th October 2024, it was announced that on behalf of the UK Government’s Office for Life Sciences, CPI has created the MedTech Accelerator for companies to apply for up to £30,000 of funding. An exciting opportunity for companies to lean into extra support which is most likely critical for progression of their product compliance journey.
What is the MedTech Accelerator?
It has been developed to help small and medium-sized business to navigate the complex and ever-changing MedTech regulatory landscape and for those who rely on external expertise to develop, commercialise and register life-changing products onto the market, to allow reduction on NHS services and improve patient safety.
This comes after the HealthTech Regulatory Innovation program (HealthTRIP) funded by Innovate UK back in 2022, which similarly help support SMEs overcome regulatory challenges but also hurdles that come along within Quality assurance. The programme awarded 277 companies.
Who is the Accelerator for?
The funding is aimed at UK SMEs developing or offering medical device (including Software as a Medical Device) and diagnostics (including IVD) products or services. Although pharmaceutical products are not considered eligible under this programme, combination medical products such as drug delivery devices would be considered eligible. If you are not sure if your product is eligible, you can reach out to us here at IVDeology to discuss further and we’d be happy to chat.
Am I eligible?
Only UK-based SMEs are eligible to apply to this programme.
Applications will only be accepted from and will be awarded to a single legal entity. Only one application per company or company group is allowed.
Applications must be from a UK registered SME company which is developing or currently producing and selling MedTech as they are outlined in the Medicines & Medical Devices Act 2021
The regulatory landscape for MedTech is constantly changing, including a divergence between the UK and EU systems. This is leading to some UK companies finding their products no longer meet the regulatory requirements to be sold within the EU. The MedTech Accelerator: Rapid Regulatory Support fund aims to help SMEs overcome this barrier and hopefully reduce timelines, release financial tension, and encourage businesses to keep moving forward with their innovations and offer some expertise comfort, which is where IVDeology come in.
How do I apply?
Applications opened on Wednesday 9th October 2024, at 9am and close on Thursday 31st October 2024, at midday UK GMT.
CPI will review applications regularly, and if they receive 300 before the deadline, they will close applications early. Companies are, therefore, encouraged to apply as soon as they can as it is a first come first serve.
Results Announced: by Friday 29th November 2024 but applications could be stopped earlier dependent on which is reached first, the 300 applicant limit or the date.
You said IVDeology can help – tell me more?
IVDeology have been dedicated to supporting companies of all sizes with their compliance journey since we began in 2018, and regulatory affairs is a HUGE part of that. But we especially understand the strains and challenges SME companies face, starting with design and innovation to regulatory challenges, getting on the market and actually staying there.
We have played a big part in some of our customers funding journey, including a company that applied for the 2022 HealthTRIP innovation grant (as previously mentioned) and used our services to support and perform the following:
Regulatory Health Assessment: this allowed us to find any gaps but also strengths within their design and development of the device and highlight areas best to support including being able to put together a regulatory roadmap
A gap assessment: this allowed us to review all processes and controls, including technical documentation for Quality assurance as well as regulatory
Workshop training sessions: this allowed us to work closely with the team to not only present the work and support, but allow learning opportunities around requirements and what they mean personally to their business
Q&A sessions: This allowed focused time with the customer and IVDeology to present any questions, raise any queries and catch up sessions to discuss the outcomes of the workshop sessions
Additional support hours: this allowed us to have dedicated time with the customer to work on any additional support that we may have highlighted in the gap assessments, including developing regulatory templates and processes including design and risk management (ISO14971)
A draft of a Clinical Evaluation/Performance Evaluation procedure (PER)
IVDeology are here to support you at any stage of your journey. We’re committed to putting time with our customers to understand where you are personally. We can find the gaps and identify the challenges, use our time and your funding wisely with implementing a regulatory strategy from the beginning for clarity, and work with you in a way that supports both your regs needs, but also supporting you with implementing a real working Quality management system (QMS).
We’re happy to work with you in a format that suits you best, from regular supporting hours to training and workshops, and if you’re not sure how best to decide, we’d be more than happy to book in some time to discuss what would work best for you, your team and your business.
We’re excited to see you apply, and we’ll be here to chat with you about supporting this next leg of your compliance journey. You can get in touch with us via LinkedIn, email on [email protected] or simply book time into our calendar here
Written by Casey Sedgwick, IVDeology Customer Success and Marketing Coordinator
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.
There has been a lot of discussion surrounding the focus of treatment within primary care. The NHS published guidance in August 2023 for integrating point of care IVD’s (NHS England » Integrating in vitro point of care diagnostics: guidance for urgent community response and virtual ward services). The Labour Party’s recent manifesto for the 2024 General Election stated that “Labour’s reforms will shift our NHS away from a model geared towards late diagnosis and treatment, to a model where more services are delivered in local communities” and “The National Health Service needs to move to a Neighbourhood Health Service, with more care delivered in local communities to spot problems earlier. To achieve this, we must over time shift resources to primary care and community services.” (Change Labour Party Manifesto 2024). Whilst this is good news for patients, it is not as simple as changing the location of the testing – there will be implications for the IVD industry in order to meet these proposals.
The In Vitro Diagnostic Medical Devices Regulation (Regulation (EU) 2017/746, ‘IVDR’) defines a “device for near-patient testing” as “any device that is not intended for self-testing but is intended to perform testing outside a laboratory environment, generally near to, or at the side of, the patient by a health professional.”
During Design & Development, IVD manufacturers have to determine the use environment and end users within their intended purpose. It is then their responsibility to demonstrate that the device is safe and effective when used in these environments by these intended end users and therefore there will be a number of additional requirements that need to be considered for devices intended for near-patient testing.
Performance Requirements:
The performance testing conducted will need to demonstrate that effective and reliable testing outside of the traditional controlled laboratory environments. Considerations such as the following will need to be considered:
Use Environment Testing:
Annex I section 9.4 states “The characteristics and performances of the device shall be specifically checked in the event that they may be affected when the device is used for the intended use under normal conditions:
(b) for devices for near-patient testing, performances obtained in relevant environments (for example, patient home, emergency units, ambulances).”
Testing of the device will therefore need to be conducted in the intended use environments. Manufacturers will need to show that the test can be used reliably in the environments that they indicate that the test can be used in. This could be, for example, doctor’s surgeries, A&E departments, patient’s homes or in ambulances. Any conditions specific for these environments would need to be considered e.g. vibrations or temperature fluctuations for devices intended to be used on an ambulance.
Usability Studies:
Annex I section 19.1 states that “Devices intended for self-testing or near-patient testing shall be designed and manufactured in such a way that they performappropriately for their intended purpose taking into account the skills and the means available to the intended user and the influence resulting from variation that can be reasonably anticipated in the intended user’s technique and environment. The information and instructions provided by the manufacturer shall be easy for the intended user to understand and apply in order to correctly interpret the result provided by the device and to avoid misleading information. In the case of near-patient testing, the information and the instructions provided by the manufacturer shall make clear the level of training, qualifications and/or experience required by the user.
It is important for manufacturers to have designed their device in such a way as to ensure that the intended end users can successfully use the device. Therefore it is vital that manufacturers conduct usability studies with their target end users who are often not laboratory trained personnel. This can then be used to demonstrate that consistent results can be obtained by these target end users, determine if the instructions provided with the device are adequate and help to identify if any training is required for the end users before the device can be used reliably.
Labelling Requirements:
The IVDR has also introduced specific labelling requirements for NPT (near patient testing) devices, including:
Devices labelled as Near-Patient Testing: The device label must indicate that the device is for near-patient testing. Although there are currently no symbols for this within ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer, MedTech Europe has provided some suggested symbols that can be used to indicate near-patient testing (New IVD symbols for compliance with the IVDR – MedTech Europe).
Individual Instructions for Use: Each individual device must be accompanied by its own instructions for use (IFU). For devices for professional use within a laboratory setting, if multiple devices were supplied then a single copy of the IFU could be provided if agreed by the purchaser. This is not allowed for devices intended for near-patient testing.
Paper-Based Instructions: According to Annex I 20.1(f) of the IVDR, the instructions for use must be provided in a physical paper format for near-patient tests, and, unlike laboratory based professional use devices, cannot be provided in electronic format.
Language Requirements: The languages that the Member States require for the device label and instructions for use for near-patient testing may be different to those for professional use only tests. This may add more translation costs on to manufacturers to access different markets.
The labelling provided must be appropriate to the device, its intended use, and the technical knowledge, experience, education, or training of the intended users. This will need to be considered by manufacturers when designing the labelling and tested during usability studies.
Notified Body Assessment
Whilst devices for near-patient testing are classified in their own right according to Annex VIII rule 4(b), the notified body assessment is slightly different. For Class B & Class C devices, the technical documentation of all devices for near-patient testing has to be assessed rather than the notified bodies sampling one technical file per generic device group or device category. Where a manufacturer has a number of devices for near-patient testing the increase of upfront cost to have their devices assessed will need to be considered.
Final thoughts
Whilst near-patient testing seems like a real win for patients and the direction of travel that the diagnostic industry is heading, this does provide some challenges for manufacturers. The additional burden to demonstrate that the device is effective and reliable when used outside of a laboratory setting and the potential increased upfront costs of conformity assessment is something that needs to be considered before being able to place the device on the market. For Great Britain, although the UK MDR 2002 does not specifically call out devices for near-patient testing currently, the indications from the MHRA on the future regulations is that it will be similar to the IVD Regulation with the new Essential Requirements being based on the General Safety & Performance Requirements. This is likely therefore to mean that the additional requirements for these types of devices will also be required here. However, if done correctly, near-patient testing will enable quicker diagnoses for patients and hopefully therefore better patient outcomes, which is ultimately what the IVD industry wants to support.
If you’d like to discuss near-patient testing or any of the compliance services that come along with it, from design and development to regulatory services, you can speak to us by dropping an email to [email protected] or book time with us via this link for when best suits you
IVDeology have decades of IVD (invitro diagnostics) compliance support experience within the Quality and regulatory industry, with backgrounds from microbiology to lab based experience, and recently becoming part of the Abingdon Health PLC to offer a more holistic range of services from cradle to grave of diagnostic products. Co-founder and Director of training Nancy Consterdine talks about the US classifications of devices, having worked recently with US 510K submissions including pre-submissions.
The Global Harmonisation Task Force (GHTF) published their classification guidance in June 2006 proposing a risk based, 4 tier classification system for In Vitro Diagnostic Devices. This guidance has been widely used since 2006 for new regulatory systems being set up around the world e.g. the IVD Regulation in Europe 2017/746.
However, the United States of America (US) had already introduced a 3-tier risk-based classification system back in 1976 with the amendments to the Food, Drug and Cosmetics act (FD&C) to include medical devices. This system has now been in place for 48 years, despite amendments having been made around the regulatory pathways e.g. introduction of the 510K De Novo program, enacting of the Small Business Determination program and electronic submission processes. So, how does the classification system work currently and what are the future changes that the FDA are proposing?
Figure above shows class |, || and ||| and risk (explained below)
Class 1
Low to Moderate Risk devices e.g. Transport culture medium, immunoelectrophoretic equipment, Biological stains
Subject to General Controls (Regulatory Requirements which apply to all medical devices) all covered under a quality management system:
– Registration of producers of medical devices. – Notifications and other remedies e.g. recall. – Records and reports on devices e.g. adverse event report.
Manufacturers are still visible to FDA and may be subject to audit.
Devices may be exempted from a General Control as stated in the classification regulation for that device e.g. they may be exempt from GMP other than keeping records and complaint files.
Devices are submitted via the 510K pre-market notification process but some are exempt.
Class II
Moderate to High Risk e.g. Blood Culture Assay, Rubella ELISA Test
Subject to General Controls and Special Controls: – Device specific – Evidence of meeting performance standards – Post market surveillance – Adherence to guidelines – Special labelling requirement
General Controls are considered insufficient to provide assurance of safety and effectiveness.
Devices are submitted for pre-market notification via 510K process.
Class III
High Risk e.g. Cancer Biomarker companion diagnostic assay
Subject to General Controls and Premarket Approval: – Quality Management processes and controls – Software design, development and cyber security – Analytical Verification data – Clinical Performance Data
Pre-Market Approval (PMA) application is required
Recent Developments
In January 2024, a press release from Jeff Shuren, the director of the Centre for Devices and Radiological Health (CDRH) announced the intent to initiate the reclassification process for most IVDs which are currently class III (high risk) into class II (moderate risk). They identified that the majority of these tests are infectious disease and companion diagnostic IVDs. This is in line with the FDA least burdensome approach allowing manufacturers of some devices to seek marketing clearance through the 510K premarket notification route. In the release it also talked to the FDA desire to encourage more manufacturers to develop the test and in turn increase competition and access to these important tests.
The process of reclassification has already started with a panel meeting in September 2023 identifying 3 types of infectious disease diagnostic IVDs
Nucleic acid and serology based IVDs to aid diagnosis of Hepatitis B Virus infection and management of infected patients.
Serology based IVDs for detection of human parvovirus B19.
Cell mediated immune reactivity IVDs to aid identification of in vitro responses to peptide antigens associated with TB infection.
Conclusion
The IVD industry can only welcome these moves by the FDA in conjunction with the amendment of the Quality Management System regulation (QMS) to be more closely aligned to the ISO 13485:2016 standard. It makes the USA a far more inviting prospect for initial market authorisation applications. The costs are transparent, the timelines are clearly identified and there is a process in place to present and discuss the device with the FDA in a pre-submission meeting.
There are however other considerations that need to be taken, Jeff Shuren has recently announced his retirement and Dr Michelle Tarver will assume the role of CDRH Acting Director. Also, there are presidential elections this year, will these changes impact the current trajectory of the CHRH? We at IVDeology will continue to monitor the situation across the pond, it is evident that since Brexit the UK government has been eager to foster recognition of other regulatory body approvals and it does feel that the movement of the FDA approval process is going in the same direction as that of the UK MDR.
Next steps to consider, and how we can help.
IVDeology Ltd can support with all of the above, please contact us for a friendly conversation to identify how we can support you with your compliance journey via our contact page
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
In this blog we are going to discuss our views on the benefits and need to have and maintain your Quality Management System (also known as a ‘QMS’)
IVDeology have decades of experience supporting IVD companies and manufacturers all across the globe with their Compliance journey within Quality and regulatory, and Jo Angell, our Quality and operations coordinator at IVDeology talks about the importance of a QMS that can grow with you, having experienced managing IVDeology’s own Quality management system internally at IVDeology as well as setting up and hosting other companies QMS.
What is a QMS?
Quality is defined as the “degree to which a set of inherent characteristics of an object fulfils requirements” [ISO 9000:2015, 3.6.2]
A management system is a set of interrelated or interacting elements of an organization to establish policies and objectives, and processes to achieve those objectives. [ISO 9000:2015, 3.5.3]
The 2 main standards covering QMS for Medical Device (including In Vitro Diagnostic (IVD)) manufacturers are:
ISO 9001:2015 Quality management systems — Requirements is a globally recognized standard for quality management. It helps organizations of all sizes and sectors to improve their performance, meet customer expectations and demonstrate their commitment to quality.
For medical laboratories, where IVDs are used or developed as a Lab Developed Test (LDT) the additional ISO 15189:2022 Medical laboratories — Requirements for quality and competence, can be utilised.
Why have one?
It is true that establishing and maintaining a Quality Management System requires additional investment, both financially and from a resource perspective, there are substantial benefits for having one:
Demonstrates to customers your commitment to quality
Standardisation of processes
Consistent training throughout the organisation
Ensures continuous improvement
Improved productivity and efficiency
Reduced waste steps
Improved customer satisfaction
Ensures controls are in place to make safe and effective products
Identification and control of risks
Control and assessment of suppliers
An effective QMS can provide a solid foundation of quality and safety in a consistent and well-organised ecosystem
You will need one if you are intended to place IVDs on market
As a legal manufacturer of an IVD or medical device a QMS must be implemented and compliant to the applicable regulations where you place your device on market. For EU CE marking under the new IVDR transitional timelines, this shall be no later than 25th May 2025. This is less than 12 months away!
Who’s responsible for maintaining the QMS?
Typically, this is the role of the Quality contact in any organisation. However, establishing a quality culture, and ensuring the QMS has been built, and maintained effectively is the role of the organisations top management. They need to demonstrate leadership and a commitment to the QMS.
Maintaining your QMS
A good and efficient QMS supports your company with the best way to do things, by having input from across the organisation these processes can be agreed on and will be committed by everyone in your organisation. An effective QMS should be everyone’s objective, not just Quality!
A QMS should grow as your organisation grows
A QMS is not a one size fits all, it needs to build and grow with your organisation and will never be a finished article, it should always be continually improving. The complexity and scope should also reflect the nature and size of your organisation.
eQMS are great but…
Electronic QMS software provide a great tool, but you need to build the QMS with you in mind. These will never be an off the shelf ready to go package. All templates will need to be customised and adapted to fit your organisation and processes, otherwise the QMS just won’t work.
You have the certificate and placed the product on market – but what next?
“The manufacturer shall institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase and to implement appropriate means to apply any necessary corrective actions, taking account of the nature and risks in relation to the product.”
This means that as manufacturers you still need to be collecting data on how effective your device is – monitoring your customer complaints and feedback, any incident reporting, your manufacturing information, looking at your trends, to mention just a few possible sources of information. This data should then be reviewed to determine whether any updates are required and if so, these actions should be documented appropriately. Potential updates could impact your:
Risk Management File – Is the Severity of the risks impacted? Does it impact your frequency of occurrence of known risks? Are there new risks that you haven’t included?
Instructions for Use & Labelling – Do you need to add additional warnings? Are your instructions clear enough?
Training – Is any training that you provide sufficient? Is additional training necessary for your users?
Other products – Does the issue impact other devices you manufacture
5 Top Tips from the team on how to effectively build and maintain a QMS
Get buy in from senior management – if they don’t understand what a QMS is, and why it is important (and not just required), it will never be supported and managed effectively.
It is a growing, living thing, the more you feed it, the stronger and more robust it will be. It needs love and attention to get the most out of it.
QMS software will save you time and money in the long run.
Most non-conformances are raised against your own processes, not the standard. Make your procedures as simple and as clear as possible, ensure the people doing the work are involved in creating the processes, they know their processes the best!
Use internal audits to strengthen and improve your QMS and use your business risk assessments as a tool to help the business overcome challenges and move on new opportunities
Being Legal Manufacturer (all QMS responsibility lies with us)
Build your QMS for you
Host your QMS within our ISO certified system or we can put you in touch with Cognidox, a QMS system we use at IVDeology ourselves
Our team of experts have a proven track record for the development and maintenance of Quality Management System ranging from SME to large IVD manufacturers. To hear more about how we can support, please contact [email protected] or click ‘get in touch’ to book in with our customer success coordinator
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:
Person Responsible for Regulatory Compliance (PRRC)
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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