Sushvin Consultancy Services Medical Devices Industry Updates Newsletter May 2024
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Sushvin Consultancy Services has undertaken an initiative to start a monthly newsletter since April 2023 to provide latest updates from pharmaceutical and medical devices industry.
This will enable us to educate industry participants of latest happening, changes or updates to standards, guidance and regulations. As a part of this initiative, this month’s newsletter will cover updates from medical devices industry for the month of May 2024.
#uk #europeancommission #mhra #mdcg #usfda #medicaldevicenewsletter #compliance #RA #QA #QARA #consultancy #audits #eumdr #euivdr #ukmdr #comment
There have been few updates in the month of May 2024. These are as follows:
UK Updates
Common specification requirements for in vitro diagnostic devices
MHRA seeks views on possible amendments to the Medical Devices Regulations 2002 to include common specification requirements for manufacturers of IVD devices.
This consultation closes at 11:59pm on 14 June 2024
Consultation description
MHRA is inviting members of the public, including the patients, medical device researchers, developers, manufacturers and suppliers, clinicians, other healthcare professionals to provide their views on the introduction of common specification requirements to the regulatory framework before IVD devices can be placed on the GB market. We are also seeking views on the removal of the Coronavirus Test Device Approval (CTDA) process to avoid duplication of regulatory requirements for COVID-19 tests against the Common Specification requirements.
Notify MHRA about a clinical investigation for a medical device
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
Updated guidance for manufacturers.
This document replaces Guidance Note 1 ‘Guidance for manufacturers on clinical investigations to be carried out in the UK’
Where a clinical investigation includes sites in both Great Britain and Northern Ireland, submission to the MHRA must be made in line with the requirements of the EU MDR. By meeting the EU MDR, requirements of the UK MDR 2002 for clinical investigations are deemed to be satisfied. Therefore, a single application made to MHRA under the EU MDR will cover any sites proposed in both Great Britain and Northern Ireland for the same clinical investigation.
This guidance document applies to all clinical investigations being conducted in the UK; however text boxes highlight where requirements differ for Northern Ireland.
Impact of AI on the regulation of medical products
Implementing the Artificial Intelligence (AI) White Paper principles.
This publication provides on update on the MHRA’s use of AI as a regulator of AI products, as a public service organisation delivering time-critical decisions and as an organisation making evidence-based decisions that impact public safety. It is the MHRA response to the Secretary of State letter of 1 February 2024 .
MHRA presents conclusions in the paper as below:
The MHRA recognises the transformative potential of AI in shaping the future of healthcare and the significant contribution AI can make across all its regulatory functions. We have adopted the five key principles set out in the Pro-innovation approach to the regulation of AI and we are determined to embrace emerging technologies with vigilance and foresight, to ensure that we use them effectively for the greater good of public health.
We are committed to taking a proportionate approach to regulating AI medical products, which takes into account the unique challenges of these products. Our collaboration with the IMDRF and in particular our partnership with the US FDA and Health Canada, will ensure safe and responsible use of AI in medical products and keep the UK at the forefront of international best practice.
As a public service organisation delivering time critical decisions, and as an organisation that makes evidence-based decisions that impact on public and patient safety, we are committed to exploring opportunities to make best use of AI. We are committed to embracing AI responsibly, in alignment with the five key principles, to protecting public health and advancing innovation in the healthcare landscape.
Software and artificial intelligence (AI) as a medical device
Updated 8 May 2024
Software (including AI) plays an essential part in health and social care. In the UK, many of these products are regulated as medical devices (or as in vitro diagnostic medical devices (IVDs). This guidance provides access to important Software Group outputs that might be of assistance.
Contents
This initiative signals an important step towards a new regulatory framework for medical devices in Great Britain which protects public health, ensures access to MedTech innovations, and maintains an attractive market for industry.The Medicines and Healthcare products Regulatory Agency (MHRA) has (on 21 May 2024) published a statement of?policy?intent for international recognition of medical devices.
The MHRA’s statement of policy intent describes how the UK Government intends to recognise regulatory approvals from Australia, Canada, the European Union and the United States of America depending on device type, class, and prior approval. The MHRA continues to review the list of comparable regulator countries and is in active discussions with the Pharmaceuticals and Medical Devices Agency (PMDA) to explore the recognition of medical device approvals from Japan.
The MHRA’s statement of policy intent focuses on ensuring safe access to quality-assured medical devices and reducing the duplication of assessments by comparable regulators to enable resource to be focused on more innovative products for the benefit of patient health. This statement will also allow manufacturers to start considering whether their devices will be eligible for the proposed alternative routes to market.
The proposed framework is still in draft, and the final version would be integral with the future core regulations.
More information on Statement of policy intent: international recognition of medical devices?is available on the following link
Statement of policy intent: https://lnkd.in/d4nWf3QP
Sushvin Provides UK Responsible Person (UK RP) Services
Are you a legal medical device/IVD manufacturer located outside the UK and would like to market your product in the UK, then you will require a UK responsible person who will act on behalf of the manufacturer to ensure all the responsibilities detailed within the updated UK MDR 2002 regulations are met.
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As a legal manufacturer, organisations will have to register their devices prior to be placed on the UK market.
If you need UK Responsible Person (UK RP) services , please contact SUSHVIN for more information.
Sushvin Provides PRRC (Person Responsible for Regulatory Compliance) Services
If you are planning to market your product in the EU and if you require PRRC (Person Responsible for Regulatory Compliance), we have a team of experienced regulatory professionals who can help you assist with PRRC services and get you regulatory compliant as per MDR 2017/745 and IVDR 2017/746
If you need PRRC Services , please contact SUSHVIN for more information.
EU Updates
May 2024
MDCG 2024-6?Preliminary re-assessment review (PRAR) form template (MDR)
MDCG 2024-7 Preliminary assessment review (PAR) form template (MDR)?
MDCG 2024-8 Preliminary assessment review (PAR) form template (IVDR)?
MDCG 2024-9 Preliminary re-assessment review (PRAR) form template (IVDR)
The 'analysis phase report' states: "the problems facing combined studies stem from a lack of alignment between the CTR, IVDR and MDR."
The proposed solutions centre around greater alignment and more communication. Unlike at the beginning of the study, there is no proposal for regulatory change.
USFDA Updates
Remanufacturing of Medical Devices
Guidance for Industry, Entities That Perform Servicing or Remanufacturing, and Food and Drug Administration Staff
Because of the apparent confusion between servicing and remanufacturing, FDA committed in the FDA Report on Device Servicing to issue guidance that clarifies the difference between servicing and remanufacturing activities. To assist with this clarification, FDA focuses this guidance on those activities that are likely remanufacturing.
This guidance addresses activities performed on devices that are intended to be reused and maintained. This guidance discusses whether activities performed by OEMs and third parties on such devices are likely remanufacturing. This guidance is not intended to adopt significant policy changes, but to clarify FDA’s current thinking on applicable definitions, and clarify, not change, the regulatory requirements applicable to remanufacturers. The concepts in this guidance are also not intended to alter or supersede existing regulations and policies related to the regulatory threshold for submitting a marketing submission for a device.
The products included within the scope of this guidance are devices as defined in section 201(h) of the FD&C Act, including software and electronic products that meet the definition of a device. In general, the concepts discussed in this guidance are meant to apply to all reusable devices, irrespective of their classification into class I, II, or III, including those subject to premarket approval. This guidance is not intended to address reprocessed single-use devices.
NIST Updates
Comments containing information in response to this notice must be received on or before June 2, 2024, at 11:59 PM Eastern Time.
This document is a companion resource for Generative AI to the AI Risk Management Framework (AI RMF), pursuant to President Biden’s Executive Order (EO) 14110 on Safe, Secure, and Trustworthy Artificial Intelligence. The AI RMF was released in January 2023, and is intended for voluntary use and to improve the ability of organizations to incorporate trustworthiness considerations into the design, development, use, and evaluation of AI products, services, and systems.
This companion resource also serves as both a use-case and cross-sectoral profile of the AI RMF 1.0. Such profiles assist organizations in deciding how they might best manage AI risk in a manner that is well-aligned with their goals, considers legal/regulatory requirements and best practices, and reflects risk management priorities.
Use-case profiles are implementations of the AI RMF functions, categories, and subcategories for a specific setting or application – in this case, Generative AI (GAI) – based on the requirements, risk tolerance, and resources of the Framework user. Consistent with other AI RMF Profiles, this profile offers insights into how risk can be managed across various stages of the AI lifecycle and for GAI as a technology.
As GAI covers risks of models or applications that can be used across use cases or sectors, this document is also an AI RMF cross-sectoral profile. Cross-sectoral profiles can be used to govern, map, measure, and manage risks associated with activities or business processes common across sectors such as the use of large language models, cloud-based services, or acquisition.
This work was informed by public feedback and consultations with diverse stakeholder groups as part of NIST’s Generative AI Public Working Group (GAI PWG). The GAI PWG was a consensus-driven, open, transparent, and collaborative process facilitated via virtual workspace to obtain multistakeholder input and insight on GAI risk management, and inform NIST’s approach. This document was also informed by public comments and consultations as a result of a Request for Information (RFI) and presents information in a style adapted from the NIST AI RMF Playbook.
Sushvin Provides UK Responsible Person (UK RP) Services
Are you a legal medical device/IVD manufacturer located outside the UK and would like to market your product in the UK, then you will require a UK responsible person who will act on behalf of the manufacturer to ensure all the responsibilities detailed within the updated UK MDR 2002 regulations are met.
As a legal manufacturer, organisations will have to register their devices prior to be placed on the UK market.
If you need UK Responsible Person (UK RP) services , please contact SUSHVIN for more information.
Sushvin Provides PRRC (Person Responsible for Regulatory Compliance) Services
If you are planning to market your product in the EU and if you require PRRC (Person Responsible for Regulatory Compliance), we have a team of experienced regulatory professionals who can help you assist with PRRC services and get you regulatory compliant as per MDR 2017/745 and IVDR 2017/746
If you need PRRC Services , please contact SUSHVIN for more information.