Popular ISO 9001 Quality management > ISO 13485 Quality management for medical devices > ISO 14001 Environmental management > ISO 22301 Business continuity > ISO/IEC 27001 Information security > ISO 45001 (OHSAS 18001) Occupational health and safety > Food standards > View all standards >
Access and buy standards How to access and buy > Decide which option works best for your business Buy standards > Standards subscriptions > BSOL > Full standards collections Compliance Navigator > Medical device standards
About standards What are standards? > Find out on how standards can help Have your say > Propose or comment on a standard
Standards and information Access and buy standards > Search our standards catalogue Develop a standard > Work with BSI to develop a standard
Auditing, certification and training Assessment and ISO certification > ISO certification and others eg: IATF, FSSC Auditing and verification > Supplier audits, custom audits and internal audits Product testing and certification > BSI Kitemark, CE marking and verification, Market access solutions Validate BSI-issued certificates > Check company, site and product certificates
Training courses > Individual, group and company-wide training Medical devices services > CE marking for medical devices, MDR and IVDR, quality management for medical devices Compliance software and solutions > Software tools and solutions for governance, cyber security, risk and supply chain management View all BSI services >
Consulting practices Construction safety > Cyber risk and advisory > Data management and security technologies > Environmental > Ergonomics > Industrial hygiene > Information solutions > Remediation program management > Safety > Security testing > Supply chain risk > Sustainability >
Industry reports, research and news COVID-19 > Digital construction > BIM, smart cities and connected assets Future of mobility > Global market access > Health, safety and wellbeing > Information security > Cybersecurity, privacy (GDPR) and compliance
Innovation > Internet of things (IoT) > Organizational resilience > Sustainability > - Circular economy > View all topics >
Blogs Built Environment > Cybersecurity and information resilience > Food Industry > Small Business > View all blogs >
About BSI > BSI impartiality > Our accreditation > Our clients and partners > Our financial information >
Our governance > Our legal information > Our purpose, mission and vision > Our Royal Charter > UK National Standards body > The global role of BSI as the national standards body >
Careers > Events and webinars > Media centre/press room > Social responsibility > Modern slavery statement Contact us >
Popular topics Brexit and the UKCA > In Vitro Diagnostics revision > Medical Device Regulation revision > OBL / Virtual Manufacturers >
Medical Device services CE Marking: European Regulations > Compliance Navigator > ISO 13485 Quality Management >
Electronic Cigarettes > In Vitro Diagnostics > Medicinal and Biologics > Microbiology and Sterile Devices >
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 Administration > 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 >
