zilongwang/ReadingBank huggingface dataset:
Mental Health & Addiction “This report highlights many of the challenges experienced by young people with mental health concerns. It reveals that discrimination, in particular, poses a real threat to their health and wellbeing – their ability to seek help, to express themselves, to negotiate relationships with others and to manage their lives. While the negative impacts of discrimination will often transcend age, gender, diagnosis or socioeconomic status, this report reveals that young people can face a unique set of pressures or circumstances, which serve to shape the manner in which discrimination is applied, perceived and ultimately impacts on their wellbeing.” Source: Mental Health Foundation “Mental ill-health can lead to poor work performance, high sickness absence and reduced labour market participation, resulting in considerable costs for society. Improving labour market participation of people with mental health problems requires well-integrated policies and services across the education, employment, health and social sectors. This paper provides examples of policy initiatives from 10 OECD countries for integrated services.” Source: OECD “This paper synthesises information published about Indigenous Australian gambling, and summarises issues and implications for key stakeholders. It is relevant for raising awareness and promoting community education about gambling for Indigenous Australians. It is also relevant for policy-makers and service providers interested in reducing gaps in health and wellbeing between the Indigenous and non-Indigenous populations.” Source: Australian Gambling Research Centre Long-Term Conditions This “study investigated multidisciplinary team (MDT) meetings for chronic illnesses: cancer, dementia, heart failure and mental illnesses. These teams are widely used across the NHS. They comprise different professionals, for example doctors, nurses, social workers and psychologists, and meet weekly to discuss their patients and make treatment plans. The teams work in a wide variety of different ways, not all of which may be helpful for making high-quality decisions for patients. We wanted to identify the factors that influence effective decision-making in these teams (by which we mean decisions being carried out).” Source: National Institute for Health Research “This report presents the case for a…transformative approach to preventing chronic diseases in Australia. The Mitchell Institute believes that we need to change course now so that we do not look back in one or two generations and imagine what we could have done to avoid the devastation that chronic diseases have inflicted on our society.” Source: The Mitchell Institute “The Global Asthma Report 2014 has been prepared by the Global Asthma Network (GAN) Steering Group and invited authors with additional expertise. It provides substantial
using the measures and links to examples of evidence practice.” Source: National Mental Health, Dementia and Neurology Health Network “The document gives an overview of the areas in mental health care in which pharmacists are involved, including health promotion, early detection, triage, optimising treatment outcomes, education (including addiction prevention), shaping public policies, research and interprofessional practice.” Source: International Pharmaceutical Federation Health Information “Due to a lack of uptake and utilisation, in 2015 the Australian Government announced a system overhaul, which included rebranding the PCEHR to My Health Record and moving from an opt‐in to an opt‐out system. While the overhaul attempts to address the key problems identified in a 2013 external review of the PCEHR, a number of experts have flagged concerns with the new My Health Record, which should be addressed prior to implementation.” Source: Deeble Institute “In this report, we firstly outline models of data governance in eight key markets: the UK, France, Italy, Sweden, Germany, the Netherlands, Australia and the U.S. With the insights generated from these case studies, we then develop an illustrative framework of a governance model. By defining this model, we provide recommendations of what constitutes a good governance framework.” Source: Office of Health Economics Health Systems, Costs, & Reforms “This new edition of Health at a Glance presents the most recent comparable data on the performance of health systems in OECD countries… Compared with the previous edition, this new edition includes a new set of dashboards of health indicators to summarise in a clear and user-friendly way the relative strengths and weaknesses of OECD countries on different key indicators of health and health system performance, and also a special focus on the pharmaceutical sector. This edition also contains new indicators on health workforce migration and on the quality of health care.” Source: OECD “This paper argues that providers of services should establish place-based ‘systems of care’ in which they work together to improve health and care for the populations they serve. This means organisations collaborating to manage the common resources available to them.” Source: King’s Fund
describes how HIAs can add value across a range of topics and summarizes the findings from a review of 134 planning-related HIAs conducted in the U.S. between 2004 and 2014.” Source: Robert Wood Johnson Foundation and The Pew Charitable Trusts “These papers provide some evidence on exposure to aerosol from ENDS/ENNDS, the prevalence of ENDS/ENNDS use and its association with tobacco initiation in youths, the health effects of electronic cigarettes, and the effects of ENDS/ENNDS on tobacco smoking cessation or reduction. The authors, members of academic institutions, have given their permission and approval to the publication of these papers on the WHO website.” Source: WHO Nutrition, Physical Activity, & Obesity “Decreased physical activity and increased sedentary behaviour are linked to overweight, obesity, and chronic diseases. This report evaluates school-based interventions to address these issues among children and youth.” Source: Conference Board of Canada *sign up for free account to download “This publication provides up-to-date information on the marketing of foods and beverages to children and the changes that have occurred in recent years, focusing in particular on the major shift to digital marketing. It examines trends in media use among children, marketing methods in the new digital media landscape and children’s engagement with such marketing. It also considers the impact on children and their ability to counter marketing as well as the implications for children’s digital privacy. Finally the report discusses the policy implications and some of the recent policy action by WHO European Member States.” Source: WHO “This report describes and analyses the prevalence of food insecurity in Australia and the consequent adverse implications for the health and productivity of individuals and communities. It proposes options aimed at improving the health and wellbeing of Australians who experience food insecurity. It notes the role of the agricultural sector in addressing Australian food security. It also highlights the prevalence of food insecurity in remote Aboriginal and Torres Strait Islander communities.” Source: National Rural Health Alliance “Arup has published: Cities Alive: Towards a Walking World. The built environment specialists neatly detail how walking can help shape a better world. In particular, how walkable cities can shape a better world. From social benefits, through to political, economical and environmental benefits – the report details over 50 ways the world can profit from cities being more walkable.” Source: Arup
“London Councils conducted a survey of all heads of community safety exploring the issues and challenges around mental health and ASB, finding out what practical responses are delivering results on the ground and listening to what the professionals feel they need to improve work in this area in the future.” Source: London Councils “This resource provides a brief overview of the the health and body effects of alcohol. Areas covered include the effects of alcohol on body parts, the health effects of acute alcohol use, the health conditions related to chronic alcohol use, and the effects of alcohol on other people and populations.” Source: Alcohol Advisory Council of New Zealand “Some of the characteristics of particular interest [from this survey’s results] when looking at gambling participation include frequency of participation in continuous and non-continuous forms of gambling and individual risk of gambling problems, as defined by an international problem gambling index.” Source: Health Promotion Agency Cancer & Palliative Care “Published jointly by the World Health Organization and the Worldwide Palliative Care Alliance, the Atlas is the first document to map the need for and availability of palliative care globally.” Source: WHO and Worldwide Palliative Care Alliance This guideline “offers evidence-based advice on the care of men referred to secondary care with suspected or diagnosed prostate cancer, including follow-up in primary care for men with diagnosed prostate cancer.” Source: NICE “Cancer in Aboriginal and Torres Strait Islander peoples of Australia: an overview provides a summary of statistics on cancer in Aboriginal and Torres Strait Islander peoples of Australia.” Source: Australian Institute for Health and Welfare “A rapid review was undertaken to explore the existing literature describing the of surgical and/or radiotherapy interventions in patients with (i) breast cancer, (ii) colorectal cancer, (iii) prostate cancer, (iv) cervical cancer and (v) head and neck cancer.” Source: University of Sheffield “The National Bereavement Alliance has a vision that all people have awareness of and access to support and services throughout their bereavement experience. Working with the National Council for Palliative Care and the Dying Matters Coalition, its members
"This report provides an overview of the status of the regulation of the health workforce across the Region. It relates only to regulatory regimes, not the overall functionality of each area or whether intended outcomes are being achieved. These are wider issues, beyond the scope of this initial review." Source: WHO “This evidence check review presents a summary of the evidence around how to safely manage expressed breast milk (EBM) in hospital, home and community settings.” Source: Sax Institute Inequality “Three common “Es” have high ethical and political content for health policy: efficiency, equity and equality. This article examines the links between the three, with especial attention given to (a) the claimed conflict between efficiency and equity, (b) the equity of inequalities and (c) the conflict between six equity principles: equal health, equal health gain, equal value of additional health, maintaining existing distributions, allocation according to need and equal per capita resources.” Source: Centre for Health Economics “One of the outstanding challenges policy researchers face is to establish a deeper theoretical understanding of the connections between complex social determinants and health inequities. Better and more complete conceptual models could improve researchers’ ability to quickly and effectively identify social problems, gather meaningful evidence, and support strategic policy responses. This think piece explores the significance of social dynamics as a social determinant of health.” Source: Wellesley Institute “Despite their shorter lives, poorer people make more use of NHS services – especially emergency services. Many emergency admissions affect people with existing long term conditions – such as dementia, diabetes, respiratory and cardiovascular diseases – and could be prevented by more effective primary care or outpatient care.” Source: University of York Centre for Health Economics Health Systems, Costs, & Reform “Improving Diagnosis in Health Care a continuation of the landmark Institute of Medicine reports To Err Is Human (2000) and Crossing the Quality Chasm (2001) finds that in particular, the occurrence of diagnostic errors—has been largely unappreciated in efforts to improve the quality and safety of health care. Without a dedicated focus on improving diagnosis, diagnostic errors will likely worsen as the delivery of health care and the diagnostic process continue to increase in complexity. Just as the diagnostic process is a
“This review considered the most appropriate and effective delivery mechanisms to support ongoing after hours primary health care services nationally.” Source: Government of Australia “The guide explores some of the challenges and evidence for what type of self-management support appeals to men. It identifies and explores five core themes that support better engagement of men in self-management.” Source: Health Foundation “This paper outlines the pressures and opportunities facing Australia’s health system and offers self care and improved health literacy as a ‘win-win’ solution delivering better outcomes and lower costs for consumers, health professionals and the Federal Budget.” Source: Global Access Partners Cancer & Palliative Care “This guideline updates and replaces NICE clinical guideline CG27 (published June 2005). It offers evidence-based advice on the recognition of and referral for suspected cancer in children, young people and adults. New recommendations have been added about recognising suspected cancer and referral. The recommendations have been organised by symptoms and investigation findings, as well as by the site of suspected cancer.” Source: NICE “This report explores the evidence around access to palliative care for people with terminal illnesses other than cancer. It also uses existing evidence to identify factors which trigger palliative care referrals for people with these conditions.” Source: Marie Curie The information available on or through this newsletter does not represent Ministry of Health policy. It is intended to provide general information to the health sector and the public, and is not intended to address specific circumstances of any particular individual or entity.
changemakers, their ideas, and their resources to exponentially accelerate social change so that it sweeps through systems, tipping the attitudes and behavior of individuals and institutions. Changemakers builds on Ashoka’s three-decade history to advance an “everyone a changemaker” world where people gain the skills and resources they need to collaborate on solving complex social problems.” Source: Changemakers Learning Lab “If public resources were unlimited, there would be no gaps in health coverage and no real need for voluntary health insurance (VHI). Most health systems face fiscal constraints, however, and VHI is often seen as a way to address these pressures. This study draws from the experiences of 34 countries to assess VHI's contribution to health spending and to understand its role in Europe and in relation to publicly financed coverage. It looks at who sells VHI, who purchases it and why. It also reviews public policy on VHI at the national and European Union (EU) levels and the related national policy debates.” Source: European Observatory on Health Systems and Policies Health Information & Technology “The aim of the landscape review is to collate information about the current status of PHR [Personal Health Record] activity and best practice across the NHS, evidence of PHR benefits and learning about how to address barriers to adoption; and to identify equivalent activities, benefits and barriers in social care. This will then inform NHS policy and the of these important new technologies.” Source: Royal College of Physicians Inequalities “To explore the potential for further insights into, and opportunities to address, disparities in underserved populations the National Academies of Sciences, Engineering, and Medicine held a workshop in October 2014. The workshop focused on (1) how communities are using digital health technologies to improve health outcomes for racial and ethnic minority populations, (2) how community engagement can improve access to high-quality health information for members of these groups, and (3) on models of successful technology-based strategies to reduce health disparities. This report summarizes the presentations and discussions at the workshop.” Source: National Academies Press “This briefing focuses on the role that good quality places can play in improving health and wellbeing and reducing health inequalities. It assumes that action in relation to place and communities is complemented by access to good quality, affordable housing for all.” Source: NHS Health Scotland
“The report focuses on different types of cost – productivity, healthcare, quality of life, administration and insurance – that emerge as a consequence of poor occupational safety and health. It also includes recommendations on how these costs should be estimated in the future to best inform policy-makers.” Source: European Agency for Safety and Health at Work Tobacco Control “Given concerns that e-cigarettes are being marketed to young people, Legacy recently commissioned two studies to expand the knowledge base regarding e-cigarette advertising and its impact on youth. The first study surveyed teenagers and young adults to learn more about their e-cigarette awareness, use, and advertising awareness. The second study analyzed e-cigarette media expenditure data to better understand whether and how advertising is reaching young people.” Source: Legacy for Health This work was “commissioned from leading academics examine the evidence on risks and opportunities.” Source: Public Health England Inequalities “This first part of the series focuses on the health of the poorest children in Aotearoa New Zealand. It closes with recommendations for better policies for our children.” Source: Child Poverty Action Group “This report presents data for 19 ‘process of care’ and ‘health outcomes’ indicators which focus on the prevention and management of chronic disease, and maternal and child health, Aboriginal and Torres Strait Islander people.” Source: Australian Institute of Health and Welfare “For too long there has been an acceptance in society, and even in the medical profession, that people with mental health problems and intellectual disability will live shorter lives and will suffer because of unmet health needs… The aim of this report is to start to identify what actions need to be taken to support doctors and the medical profession in changing the status quo.” Source: British Medical Association “This paper reports on a field trial, supported by Google, that used teledentistry to deliver specialist consultation to children in Victoria and pave the way for the application of teledentistry for paediatric patients.” Source: Institute for a Broadband Enabled Society Public health implications of the pSoBid study “The pSoBid study sought to examine associations between social deprivation and a variety of health indicators, and to incorporate a range of co-factors, with the aim of enhancing understanding of the relationships between social deprivation and ill health.” Source: Glasgow Centre for Population Health
illustrates this with examples of how people are involved in their care in services.” Source: Care Quality Commission Back to top Quality & Safety “The King’s Fund was commissioned by Oxleas NHS Foundation Trust to work with their Quality Board to facilitate an assessment of its existing approaches to quality improvement and to develop a strategy for future work. This case study details the approach and philosophy behind this work, which involved working with the trust’s five directorates to develop their ability to appraise their own approach to quality improvement with a view to improving performance, achieving better clinical outcomes and building further on the trust’s capacity as a learning organisation.” Source: The King’s Fund “This report looks at the first year of the Q initiative and the extensive co-design process used to create it. Q is a diverse and growing community of people, with experience and understanding of improvement, committed to improving the quality of health and care across the UK. The report identifies lessons for anyone seeking to support improvement work across organisations or through networks, as well as those engaged in designing initiatives with many diverse stakeholders.” Source: Health Foundation “This Evidence Check examines the effect of comprehensive care in acute settings on patient outcomes. The evidence shows that initiating a comprehensive care program has the potential to lead to increased patient satisfaction, increased involvement of patients in shared decision making and reduced length of stay, cost of care and hospital readmission rates.” Source: Sax Institute Back to top Mental Health & Addiction “Efforts to improve the physical health care of people with SMI (Severe Mental Illness) should empower people (staff and service users) and help remove everyday barriers to delivering and accessing integrated care. In particular, there is a need for improved communication between professionals and better information technology to support them, greater clarity about who is responsible and accountable for physical health care and awareness of the effects of stigmatisation on the wider culture and environment in which services are delivered.” Source: National Institute for Health Research “Early intervention mental health services for children and young people must be rejuvenated – and secondary schools should play a central role in this, complementing wider community and NHS provision.” Source: Institute for Public Policy Research
“Good health is central to human wellbeing, economic progress and a prosperous society. Reflecting this, the efficiency of Australia’s health care system is an important area of government policy. In this paper, the Commission has identified and assessed opportunities to improve the operation of Australia’s health care system.” Source: Australian Government Productivity Commission Back to top Cancer & Palliative Care “Policy makers, health and social care professionals, service planners and communities must talk honestly about what sort of care and support we want to give people affected by terminal illness when their needs are becoming more complex, are often being unmet and are set to grow in number.” Source: Marie Curie “A team from the Personal Social Services Research Unit (PSSRU) at the London School of Economics and Political Science (LSE) was commissioned by Marie Curie to explore the evidence on equity in palliative care and to consider the economic implications of extending palliative care to those currently under-served.” Source: Marie Curie Back to top Public & Community Health “Recognizing the challenges of improving health outcomes depends on a complex set of factors, many beyond the control of the health care system, a recent report from the Institute of Medicine (IOM) stresses the importance of population health measurement to ensure accountability to improve the quality of health care as well as population health outcomes.” Source: Institute of Medicine “Assessing the Use of Agent-Based Models for Tobacco Regulation describes the complex tobacco environment; discusses the usefulness of agent-based models to inform tobacco policy and regulation; presents an evaluation framework for policy-relevant agent-based models; examines the role and type of data needed to develop agent-based models for tobacco regulation; provides an assessment of the agent-based model developed for FDA; and offers strategies for using agent-based models to inform decision making in the future.” Source: National Academies Press *sign up for free account to download “Increasing geographical mobility, economic change and the rise of an individualist culture in the UK have contributed to the loosening of close ties in communities. Communities need to evolve, to reconnect, so that people cultivate the ‘background hum’ of sociability that has been associated with neighbourliness.” Source: Joseph Rowntree Foundation
Interventions designed to support parents have been shown to improve both children’s behaviour and parents’ wellbeing. None of the included studies identified specific tools to determine which BCTs should be employed and when. The authors recommend the systematic use of theory to identify behavioural determinants and select the most effective BCT.” Source: Sax Institute “This research involved a systematic comparison of five of NICE’s HTA programmes: Technology Appraisal Programme, Medical Technologies Guidance, Diagnostic Assessment Programme, Highly Specialised Technologies Programme, and Clinical Guidelines. The aim was to establish how differences in methods and processes between the programmes may impact on allocative efficiency within the NHS. Key differences between programmes were found in the methods of evaluation, specifically the provision of a reference case, the requirement for and type of economic analysis, and the decision making criteria used for appraisal.” Source: Office for Health Economics “The Commission worked with the National eHealth Transition Authority (NEHTA) and the Australian Government Department of Health to develop national guidelines for standardised presentation of on-screen medicines information to ensure benefit from investments in initiatives and to maximise patient safety. The guidelines provide an evidence-based approach to on-screen presentation of medicines information, incorporate Australia’s National Tall Man Lettering, and build on Australia’s Recommendations for terminology, abbreviations and symbols used in the prescribing and administration of medicines.” Source: Australian Commission on Safety and Quality in Health Care Mental Health & Addiction “Efforts to improve the physical health care of people with Severe Mental Illness should empower people (staff and service users) and help remove everyday barriers to delivering and accessing integrated care. In particular, there is a need for improved communication between professionals and better information technology to support them, greater clarity about who is responsible and accountable for physical health care and awareness of the effects of stigmatisation on the wider culture and environment in which services are delivered.” Source: National Institute for Health Research “This report examines the economic challenges of youth mental health problems in England. The main focus is on adolescents and young adults. We summarise findings from a review of the international evidence on the economic impact of youth mental health services, an analysis of the economic implications of youth mental health problems – including the failure to recognise or treat them – and an evaluation of two models of youth mental health service provision in England. We make a number of recommendations.” Source: Personal Social Services Research Unit
can assist governments in developing or modifying existing laws and implementing monitoring mechanisms.” Source: Pan American Health Organization and the World Health Organization “The health technology assessment (HTA) has carried out an independent evaluation of the clinical and cost-effectiveness of smoking cessation interventions, along with an analysis of the wider implications of potential changes to how these services are delivered in Ireland.” Source: Health Information and Quality Authority “Integrating Clinical Research into Epidemic Response: The Ebola Experience assesses the value of the clinical trials held during the 2014–2015 epidemic and makes recommendations about how the conduct of trials could be improved in the context of a future international emerging or re-emerging infectious disease events.” Source: National Academies Press “This catalogue provides tools and information resources to support EU/EEA countries in addressing the challenging issue of vaccine hesitancy. The catalogue provides examples of practices that can serve as a resource for other countries. The project was developed in the context of ECDC’s support for EU/EEA Member States in prevention and control of diseases, including effective communication to promote immunisation.” Source: European Centre for Disease Prevention and Control Nutrition, Physical Activity, & Obesity “The briefing focuses on how nutrition can be effectively integrated into public health strategies to protect and improve mental health and emotional wellbeing. It discusses what is known about the relationship between nutrition and mental health, the risk and positive factors within our diets and proposes an agenda for action.” Source: Mental Health Foundation (UK) “This report updates and extends estimates of the burden due to overweight and obesity reported in the Australian Burden of Disease Study 2011 to include burden in people aged under 25, revised diseases linked to overweight and obesity based on the latest evidence, and estimates by socioeconomic group. The report includes scenario modelling, undertaken to assess the potential impact on future health burden if overweight and obesity in the population continues to rise or is reduced.” Source: Australian Institute of Health and Welfare Quality & Safety
“The financing arrangements for health care in Australia are complex, reflecting both historical developments unique to Australia and its federal system of government. Australia's health system is a mix of public and private health care. Broadly, publicly-financed health care primarily refers to services funded through government programs such as Medicare and the Pharmaceutical Benefits Scheme, as well as public hospital services that are jointly funded by the Commonwealth and the states and territories. In addition, some health services are funded through private health insurance, individual out-of-pocket payments, and third party insurers such as motor vehicle insurers.” Source: Parliamentary Library of Australia Trends & Innovations “NPC have published 16 essays from innovative leaders in the social sector. They’re thinking about, and putting into action, new ways of achieving social change for the causes and beneficiaries their organisations exist to serve.” Source: NPC (UK) “This study responded to a call for research on how innovations and new knowledge could be spread more effectively in the NHS. It explored the emerging strategies and practices of the AHSNs as they tried to do this.” Source: National Institute for Health Research “This brief, a product of the Complex Care Innovation Lab made possible by Kaiser Permanente Community Benefit, outlines the current state of Medicaid NEMT services, its challenges, and opportunities for improvement. It explores alternative transportation models piloted by states and health plans across the country, including the use of transportation network companies, such as Uber and Lyft, to augment NEMT services.” Source: Center for Health Care Strategies, Inc Integration “With support from the Robert Wood Johnson Foundation, the Health Research & Educational Trust has developed a playbook of effective methods, tools and strategies to create new partnerships and sustain successful existing ones. The playbook also incorporates lessons learned from HRET’s Learning in Collaborative Communities cohort, communities from across the U.S. with strong, successful hospital-community partnerships. Site visits to these communities yielded insights on how to manage, strengthen and accelerate collaborations effectively.” Source: American Hospital Association “This report summarises the findings of the evaluation of the Multiagency Investigation and Support Team (MIST), a pilot response developed by WA Police (Child Abuse Squad);
Section 7 - Solutions to Essential Requirements Manufacturer’s Instructions Please indicate how relevant Essential Requirements (Annex I) of the Directive are met NSAI Review Ensure that the solutions to the Essential Requirements are completed and reference the location of the supporting documentation. Reference should also be made to the Harmonised Standards used. Reviewer & date: Queries? No Yes Number(s) Section 8 -Compliance with Harmonised Standards Manufacturer’s Instructions Please list the relevant Harmonised Standards and identify where compliance is demonstrated: If standards other than Harmonised Standards are used or where Harmonised Standards are not available, please rationalise their use. For IVDD, see Note - The 3 standards below are shown as indication only- please include all other relevant Harmonised Standards from the applicable website(s) above. Table 3 – Sample – Applicable Harmonised Standards List Harmonised Standard Compliant – YES/NO EN ISO 13485:2003 YES EN ISO 14971: 2007 YES EN 980:2008 YES Table 3 – Applicable Harmonised Standards List Harmonised Standard Compliant – YES/NO
NSAI Review: Disposition: Declaration of impartiality of Clinical evaluator (if not already submitted) Response: NSAI Review: Disposition: NSAI PMFC Review No.1 Date: Reviewer: NSAI Queries Company Query #1 – Company Response Response Disposition: Company Query #2 – Company Response Response Disposition: Company Query #3 – Company Response Response Disposition: Company Query #4 –
Company Response: Date: Response Disposition: By: Date: Accepted Yes No Rationale: If not accepted: FOLLOW-ON QUERY: Company Query #4 – Company Response: Date: Response Disposition: By: Date: Accepted Yes No Rationale: If not accepted: FOLLOW-ON QUERY: Company Query #5 – Company Response: Date: Response Disposition: By: Date: Accepted Yes No Rationale: If not accepted: FOLLOW-ON QUERY: Company Query #6 – Company Response: Date: Response Disposition: By: Date: Accepted Yes No Rationale: If not accepted:
Section 12 - Conclusion of Assessment NOTIFIED BODY STATEMENT: Conclusion – (The following details shall appear on the Approval Letter) Intended use : Indications for use: Shelf life (if applicable) : Approval conditions : ROLE Name Date File Manager Expert Opinion Biomechanical Review Electrical Review Clinical Review TSE Expert Outcome of Competent Authority Review (where applicable) (Remarks: By signing this report, the reviewer confirms that he / she has no conflict of interest with the above named company (e.g. training, consultancy, financial, personal or political) that would affect the integrity of the technical review process and hence the review results.)
Section 4 - Product Stability & On-Going Testing Using Table 5 below, please specify the current shelf-life of the product: If additional Tables are required, please copy and paste this format underneath Table 5 Table 5 Stability claims Product name Model Numbers Shelf life Time Period and storage conditions (where applicable, if not please state N/A) Claimed Shelf life In use stability On board stability Re-constitution Open vial/bottle Shipping/Transport Stability Duration of transport Expected temperatures Humidity Has the product shelf life / expiry date changed during the current product certification cycle? Yes No If yes, please explain: Is the stated shelf life based on accelerated or real time aging Yes No Please provide an update on any real time aging activities currently underway, or completed during the current product certification cycle: N/A Yes No Is regular monitoring of the stability of an IVD reagent already on the market completed? Yes No If Yes, please explain and provide data:
SECTION 2: DESCRIPTION OF DEVICE Please provide a full description of the device which demonstrates that the product is covered under Directive 93/42/EEC: Device Description: SECTION 3: INTENDED USE OF THE DEVICE 1. Please enter a full description of the intended use of the device, which supports the product classification: 2. List of any contra-indications : 3. List of any precautions / warnings : Section 4: Previous Existing Legislation 1. Does the device have any existing approvals (e.g. FDA 510(k)) Yes No 2. If “Yes” – please advise 3. Does this product, labelled with your Name & Address carry CE Marking with another Notified Body Yes No
4. Confirm start date of real time Packaging studies 5. Please list all relevant reports which substantiate Packaging shelf life – Section 10: MEASURING FUNCTION 1. Describe how the device is designed and manufactured to provided sufficient accuracy and stability within appropriate limits of accuracy 2. Provide details of the relevant validations 3. Define the limits of accuracy 4. Describe how the measurement, monitoring and display scale are designed in line with Ergonomic principles 5. Describe the units of measure
2. Please list the relevant revised/updated Harmonised Standards in Table 2 below Section 6: Risk Management 1. Did the proposed change affect or change any existing risks Yes No If “no” please justify: 2. Did the proposed change introduce any new risks Yes No If “no” please justify:
If “Yes” please provide the relevant Unique Identifier number(s) – If “No” please: a. Justify b. If applicable, please submit a copy of the Competent Authority report(s) along with the completed NSAI Vigilance Form located at [ -“Vigilance Reporting”] to 4. Has this product been the subject of product recalls or Incident Reports in other Regulatory geographies outside EU? If yes, please summarize and provide details with supporting documentation. 5 For those failure modes associated with the identified Root Causes, please clarify if the Occurrence Rates outlined in the Risk Management File required an update based on the observed real world rates. SECTION 3: INTENDED USE OF THE DEVICE 1. Is there a change in Intended Use Yes No 2. Please enter a full description of the revised intended use and/ or indications for use of the device- 3. Does this change impact the classification/rule Yes No If “No” please justify -
SECTION 5: DESIGN AND MANUFACTURING OvERViEW 5.1 Does this change require an update or new design development documentation – e.g. design and development plan, update to design input output matrix, product specification: Yes No If Yes, please provided copies: If No, please justify: 5.2 Does this change require an update to the manufacturing process or product specification/release criteria? Yes No If Yes, please provide a List of manufacturing processes and validation status & updated Product specification or product release criteria If No, please justify: Section 6: Solutions to Essential Requirements and Harmonised Standards Please indicate how relevant Essential Requirements (Annex I) of the Directive are met for the proposed changes. 1. Location of the revised solutions to Essential Requirements in the supporting documentation 2. Please list the relevant Harmonised Standards in Table 2 below Add rows as required.
4. If no update to Risk Management File, please provide rationale: Section 9: Sterilisation & STABILITY 9.1 Sterilisation Validation For devices provided sterile 1. Does the proposed change affect sterilisation Yes No If “No” please justify - 2. Is a full validation/revalidation required Yes No 3. If a full validation/revalidation not completed, please provide an Adoption justification/rationale report
Section 14 – Clinical Performance (Human) 14.1 Clinical Evaluation 3. Please identify the individual(s) who performed the clinical evaluation - Is their CV included? Yes No Is a declaration of interest of the evaluators included Yes No If “No” please explain - Please provide justification of the choice of evaluator(s) - 4. Has a clinical investigation been performed to demonstrate the safety and performance of the device Yes No If “No” please explain - 5. For this device : a. Are any further clinical investigations planned Yes No b. Are any further clinical investigations on-going Yes No c. Are any other relevant clinical investigations completed Yes No d. How often is the CER updated with data from the post market surveillance(reference Annex X 93/42/EEC If “Yes” please provide additional information including study identifier and status (note – not limited to EU S&P studies / Investigations, i.e. include reference to Other Geographical Reg Requirements, studies/investigations for reimbursement purposes, etc) 6. For clinical investigations please submit the following: Letter of no objection from Competent Authority(s) (CAs) or other regulatory agency(s) as appropriate Clinical investigation plan and amendments for which no grounds for objection were raised Ethics committee opinion(s) and comments arising from their review Signed and dated final report (signed by the sponsor, the co-ordinating clinical investigator – if appointed – and principal investigator at each site).
6. Control tests on finished products Please supply details of the qualitative and quantitative tests carried out to control the medicinal substance in the device. 7. Toxicity Please provide reference to the known toxicological profile of the medicinal substance. In the case of new active substances, the results of the toxicity tests should be supplied 8. Reproductive Function Please provide reference to the known profile in relation to reproductive function, of the medicinal substance. In the case of new active substances, the results of the appropriate tests should be supplied
2. Please confirm the number of sterilisation cycles that the device and packaging were subjected to prior to stability testing - 3. Please describe the preconditioning applied (eg. Ageing, transport etc): 4. Is compliance with EN ISO 11607 latest version claimed Yes No If “no” please justify: 5. If submitting Accelerated Aging data to support Shelf life, please confirm start date and expected completion date for real time Packaging studies 6. Please list and supply all relevant reports which substantiate Packaging shelf life – SECTION 8: BIOCOMPATIBILITY 1. Is the biocompatibility status of the device affected by this change Yes No If “no” please explain: 2. Is compliance with EN ISO 10993-1 latest version claimed Yes No If “no” please explain: 3. Please identify additional testing requirements in Table
2. Please provide the document number and location of the Clinical Evaluation Report (CER) - 3. Does the supporting documentation submitted to NSAI include: Literature search protocol Full text of articles referenced in the CER. If not please explain: 4. Does the CER comply with MedDev 2.7.1 Yes No Version of MedDev used: 5. a. Does the CER address the relevant risks of predicate device Yes No If “No” please justify - b. Does the CER address Post market surveillance and or PMCF ie. Registry or study (reference MED DEV 2.12 /2 ) Yes No c. How often is the CER updated with data from the post market surveillance (reference Annex X 93/42/EEC How often is the CER updated? Please provide justification for the frequency of update 6. Please identify the individual(s) who performed the clinical evaluation - Is their CV included? Yes No Is a declaration of interest of the evaluators included Yes No If “No” please justify - 7. Please provide justification of the choice of evaluator(s) 8. Was a clinical investigation completed to demonstrate the safety and performance of the device Yes No
information. Please submit an unsigned version of this Application in Word as well as a signed copy - either scanned/secured (pdf) copy. All application forms and supporting data to be forwarded in soft copy via the following (Hard copies not required) NSAI upload facility : see Supporting documents should be in SEARCHABLE format Applications and supporting documentation must be in English Please send a representative sample of the device(s). This is particularly important for new/novel devices. Any video of procedures/simulated use would also be helpful, if available.
Tyvek® 1059B 3. Please provide an Executive Summary describing the assessment of the introduction of the Transition Tyvek Material for the products approved under the noted certificate (Note: please clearly highlight any packaging process changes (Internal “Final” seal or supplier seals) required, and relevant mitigating activities) 2: Please provide a description of the Packaging Solution(s) utilised for the products certified under the relevant Annex II.4 certificate (252.XXX / 253.XXX) Example information outlined below: Device Model Number (eg CVG-123) Sterile Barrier P/N (e.g. xxxx-x) Sterile Barrier (e.g Tyvek pealable Pouch) Packaging Process Equipment (e.g. Sealer 1, 2, 3)
Section 4: Previous Existing Legislation 1. Does the device have any existing approvals (e.g. FDA 510(k)) Yes No 2. If “Yes” – please advise 3. Does this product, labelled with your Name & Address carry CE Marking with another Notified Body Yes No If “Yes” – this is considered a TRANSFER Please refer to applications checklist 4. If you are not the maker of the device does this identical product carry CE marking by the maker Yes No If “Yes” – Please supply a copy of the contract between your company (Own Brand and the actual maker (Original Equipment Manufacturer-OEM) Detailing responsibilities for: Design Changes. Vigilance Issues and complaint Handling. Changes to the OEM Quality Management system and communications about such changes. Changes to the OEM manufacturing environment and communications about such changes. Section 5: Labelling and IFU 1. Location of the sample Label(s) & IFU in the supporting documentation Please include all levels of labelling – device, packaging, carton, etc. Note - Draft labelling is acceptable for New Applications 2. Are copies of all labelling provided? Yes No If No please rationalize that the sample provided is representative of the family
Section 11: Performance evaluation 1. Please provide the necessary performance evaluation report to support the safe use of the device following this change. These data should arise from studies in a clinical or other appropriate environment or result from relevant biological references. This should include the following: 2. Performance Data including claims should be supported by a reference measurement system and should contain information on Yes No Reference Methods used Yes No Reference Materials used Yes No The known Reference values Yes No Accuracy and measurements Yes No
limited to, octagonal stop signs or speed limit signs. Temporary Signs. Portable and temporary banner signs are allowed for a maximum period of five (5) days in any sixty (60) day period, subject to the requirements of this section. Longer time frames and greater frequencies may be allowed by conditional use permit. Digital Signs. Digital display signs are not allowed, except as specifically permitted by this ordinance. Nonconforming Signs. A non-conforming sign may be refaced, removed and replaced for maintenance purposes, however it shall not be increased in size, the support system shall not be expanded and the sign shall be removed in its entirety upon the determination by the Zoning Administrator that the sign has been abandoned or is in disrepair or the support system is failing to the point where it poses a safety hazard. Public Property. No signs, except for official traffic signs, shall be placed on or overhang public property, except where specific permission is granted by the Planning Commission or as allowed by this ordinance in the Downtown Mixed Use District. Maintenance. All signs must be constructed and maintained in good order. Non-maintained signs or signs for discontinued business shall be removed Coordination/Appearance. All permanent signs on a property must be coordinated to create a coordinated or consistent appearance in regards to size and color. Area. Sign area shall be measured by means of one rectangular or circular shape that encloses all sign elements except those elements used exclusively for support. Measurements shall be of the sign itself, regardless of whether both sides are visible or used. Sign Height. Sign height shall be measured from the ground surface to the highest portion of the sign. Electrical Signs. Electrical signs must be installed in accordance with the current electrical code and a separate electrical permit from the State must be obtained prior to placement. Setbacks. Permanent signs can be allowed up to the right-of-way as long as there are no safety or maintenance concerns as determined by the Zoning Administrator. Onsite Signs Downtown Mixed Use District General. Signs in the Downtown Mixed Used district shall be designed and installed so as to be easily readable to pedestrians and slow moving vehicles. Permitted Signs Building identification signs Plaque Signs Awning and Canopy Signs Projecting Signs Hanging Signs Monument Signs Window Signs Banner Signs Portable A-frame Signs