Clinical trials for medical devices. Conformity assessment and the CE mark. Conformity assessment procedures Here we set out in broad terms the conformity assessment routes to be followed by manufacturers to demonstrate that their devices meet the essential requirements of the Medical Devices Directive (MDD).
The routes depend on the classification of the device. The conformity assessment routes Class I devices The manufacturer is responsible for ensuring that their product complies with all the relevant essential requirements of the MDD and must draw up a written statement to this effect (self-declaration). Additionally, manufacturers of sterile products and devices with a measuring function must apply to a notified body for certification of the aspects of manufacture relating to sterility or metrology. Guidance on medical device stand-alone software (including apps) The following guidance is for healthcare and medical software developers who are unsure of the regulatory requirements for CE marking stand-alone software as a medical device.
Introduction Many manufacturers, software developer, academics, clinicians and organisations are using software for both healthcare and social care needs. This guidance explains how this technology is regulated. It covers stand-alone software (also known as software as a medical device) but not software that is part of an existing medical device because this seen to be part of the device, eg software that controls a CT scanner. Key points and existing guidance. Digital technologies. In this section New digital technologies Internet-enabled mobile devices, such as smart phones, tablets and PDAs, are expected to become the main internet providers for users in the next decade.
They will be capable of accessing, communicating and sharing information anywhere. At the same time there will be more flexible and immersive ways of displaying information, including 3-D holographic imaging and augmented reality (which overlays data and images onto a physical environment). Wireless-enabled sensors embedded in everyday objects will be able to send information and enable us to interface with computing through touch. Health Developer Network Clinical Dashboard Testing - Health Developer Network. To help you test your Clinical Dashboard implementation, this section of the Test Centre contains several templates and examples for: Test StrategyTest PlanTest SpecificationTest Report This document defines the Connecting for Health Clinical Dashboard Project Test Strategy and approach of incremental testing stages required to ensure the acceptability of the delivered solution.
It covers all phases and releases. Health Developer Network. The Health Developer Network is a NHS England website that contains technical information, software tools, source code and data that will be of interest and use to software developers who are designing and building software for use in health and social care.
The website is divided into seven distinct zones to help you navigate the website quickly and easily. You can also search across the whole website by using the search box at the top of the page. Library Contains technical articles describing a wide range of systems, services and data used in the health and social care sector and a range of software development topics. The library is sub-divided into: Architecture, Design and PatternsIdentifiers and NamesIntelligence and AnalyticsInteroperability and IntegrationSafe, Legal and SecureSystems and ServicesTechnologies, Tools and MethodsTransports and Networks Downloads & Data Contains development tools and source code to download. Test Centre Learn Community Market Square Contributors. Health Apps Library. Skip to FAQs This is the first public release of the Health Apps Library which was launched by NHS England in March 2013.
It aims to make it simpler for people to find safe and trusted apps to help them manage their health We consider a health app to be a program for your mobile phone, tablet or a website that helps you manage your health. These must be for use by the public rather than clinicians. Apps listed in the Health Apps Library can help improve health and reduce cost by: Patient Experience (Px) – A New Paradigm for Medical Device Development. By combining the safety and rigour of human factors engineering with the broader scope of user experience design, medical device manufacturers can develop products that improve patient compliance.
Designing a great medical product means that it has to be safe. Designing a great consumer product means that people have to love it. Usability Testing Medical Devices. Turf. Manuscript Publication Search. EHR Usability. Updated April 18, 2014 (Page is updated monthly on the 19th.
For more frequent resource alerts, follow EHR Science on Twitter:@ehrscience.) The Usability page focuses on major national policy reports/documents and selected research articles going back to 1999. Resources are selected with an emphasis on usability as a software selection tool and as an adjunct to system design. As always, if you have comments and suggestions, please submit them using the contact form. BooksTidwell J. Microsoft Inductive User Interface Guideline. Websites Usability Professionals AssociationUsabilityProfessionals.org – Seemingly, everything related to usability is somewhere on the site. Medical Devices Classification. This section describes how ‘general’ medical devices (i.e. those that fall within the scope of the Medical Devices Directive) are categorised into classes according to the degree of risk inherent in the device.
Abbreviations used MDD – Medical Devices Directive (93/42/EEC) AIMDD – Active Implantable Medical Devices Directive (90/385/EEC) IVDMDD – In Vitro Diagnostic Medical Devices Directive (98/79/EC) The directives are available on the European Commission website (external link) Background The MDD covers a vast range of products from first-aid bandages and walking frames to CT scanners and non-active implants. Given this wide range, it is not justifiable to subject all devices to the same levels of conformity assessment. Clinical Investigation and Evaluation. Association of British Healthcare Industries (ABHI) the association for the medical technology sector. Www.mhra.gov.uk/home/groups/pl-a/documents/publication/con1004418.pdf.
Www.mhra.gov.uk/home/groups/comms-ic/documents/websiteresources/con2031677.pdf. The Medical Devices Regulations 2002. Legislation.gov.uk The National Archives Search Legislation Advanced Search.
Clinical trials for medical devices. A manufacturer may need to carry out a clinical investigation (clinical trial) as part of the process of obtaining a CE marking for a medical device, ie to demonstrate that the device complies with the essential requirements of the relevant directive. It is a legal requirement (the Medical Devices Regulations 2002 No. 618) that a manufacturer notify the UK competent authority (the MHRA) of their intention to undertake a clinical investigation of a non-CE-marked medical device within the UK, at least 60 days before commencement of the proposed investigation.
Please read our document ‘Clinical investigations of medical devices – guidance for manufacturers' (463Kb) for detailed information on the process of clinical investigations. A summary is given below. Note: Investigations of in vitro diagnostic medical devices are regulated as performance evaluations and guidance on the requirements for these is on our in our document on the IVD Directive. Information needed (463Kb). Fees Timescales. The Healthy Twitter. Www.mhra.gov.uk/home/groups/pl-a/documents/publication/con1004417.pdf. Www.mhra.gov.uk/home/groups/pl-a/documents/publication/con1004417.pdf.