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 View all standards >
Access and buy standards How to access and buy > Buy standards > Standards subscriptions (UK website) > BSOL > Full standards collections Compliance Navigator > Medical device standards
About standards What are standards? > Have your say > Consumer alerts > Know which products have been recalled
Standards and information Access and buy standards > Develop a standard (UK website) > Online subscription services (UK website) > BSOL, Compliance Navigator, Eurocodes PLUS, and BSI Membership Knowledge services (UK website) > Shaping strategies, creating new standards and frameworks, research and insights and consultancy advisory services
Auditing, certification and training Assessment and ISO certification > Auditing and verification > Product testing and certification > BSI Kitemark, CE marking and verification, Market access solutions Validate BSI-issued certificates >
Training courses > Medical devices services > BSI Certification Guidebooks > BSI Connect > Software tools and solutions for audit, risk, compliance and supply chain management
Industry reports, research and news COVID-19 > Digital construction > BIM, smart cities and connected assets Future of mobility > Global market access > Health, safety and well-being > Information security > Cybersecurity, privacy (GDPR) and compliance
Innovation > Internet of things (IoT) > Organizational resilience > Sustainability > - Circular economy > - Net zero > View all topics >
Blogs Built environment > Food Industry > Healthcare > Health and Safety > Kitemark > Organizational Resilience > Sustainability >
About BSI > BSI impartiality > Our accreditation > Our clients and partners > Our financial information >
To 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 > Directive 90/385/EEC AIMD > Directive 93/42/EEC MD > Directive 98/79/EC IVD > Directive 2007/47/EC > Central Management Committee Guidance > MDD-IVDD communication 2012-540 > MDD Regulation proposal 2012-542 > IVDD Regulation proposal 2012-541 > Medical Device Software 2.1/6:2012 > MedDev 2.7.1 Rev 4 > MHRA Guidance on Human Factors >
Regulatory links Stay up to date with regulatory changes. MHRA Medicines and Healthcare Products Regulatory Agency > European Commission Medical Devices > US Food and Drug Administration CDRH > NBOG Notified Body Operations Group > IMDRF International Medical Device Regulators Forum >
Professional associations Keep in touch with key professional associations. RAPS Regulatory Affairs Professionals Society > ASQ Biomedical > FDLI The Food and Drug Law Institute > TOPRA The Organisation for Professionals in Regulatory Affairs >
Trade associations Keep in touch with key trade associations. TEAM NB The European Association for Medical devices of Notified Bodies > AdvaMed Advanced Medical Technology Association > Eucomed Medical Technology > ABHI Association of British Healthcare Industries > MDMA Medical Device Manufacturers Association > BIVDA British In Vitro Diagnostics Association >