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To help ensure you are kept up to date with the medical devices industry, we have provided key links to useful guidance documents, professional and trade associations and regulatory websites below.
Guidance documents Download the latest regulatory guidance. European Commission MDR/IVDR Factsheet June 2019 > European Commission Medical Devices guidance and legislation > European Commission Harmonised Standards > NBOG Notified Body Operations Group Guidance > EU Regulation on Medical Devices (MDR) 2017/745 > EU Regulation on In Vitro Diagnostic Medical Devices (IVDR) 2017/746 > Directive 90/385/EEC AIMD > Directive 93/42/EEC MD > Directive 98/79/EC IVD > Medical Device Software 2.1/6:2012 > MedDev 2.7.1 Rev 4 > MHRA (UK) Guidance on Human Factors >
Regulatory links Stay up to date with regulatory changes. MHRA (UK) Medicines and Healthcare Products Regulatory Agency > VWS (NL) Ministry of Health, Welfare and Sport > IGJ (NL) Health and Youth Care Inspectorate > FDA (USA) Food and Drug Adminstration > NBOG Notified Body Operations Group > IMDRF International Medical Device Regulators Forum > European Commission Medical Devices >
Professional associations Keep in touch with key professional associations. RAPS (USA) Regulatory Affairs Professionals Society > ASQ (USA) Biomedical Division > FDLI (USA) The Food and Drug Law Institute > TOPRA (UK) The Organisation for Professionals in Regulatory Affairs >
Trade associations Keep in touch with key trade associations. TEAM NB (EU) The European Association for Medical devices of Notified Bodies > AdvaMed (USA) Advanced Medical Technology Association > ABHI (UK) Association of British HealthTech Industries > MDMA (USA) Medical Device Manufacturers Association > BIVDA (UK) British In Vitro Diagnostics Association >
Media Center Stay up to date with latest news and announcements from BSI and the medical devices industry. View the latest news >
Medical device training BSI runs online, public or in-house training courses. For training at your place of work, call us on +1 888 429 6178. View all training courses >
Events and conferences We run a variety of events and conferences from seminars, exhibitions and roadshows. View all events >
