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
Consulting practices Cybersecurity and information resilience > Environmental health and safety > Supply chain management > View all BSI services >
Industry reports, research and news 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 and 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 Royal Charter > UK National Standards body > The global role of BSI as the national standards body >
Careers > Events and conferences > Media centre/press room > Social responsibility > Modern slavery statement Contact us >
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
Consulting practices Cybersecurity and information resilience > Environmental health and safety > Supply chain management > View all BSI services >
Industry reports, research and news 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 and 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 Royal Charter > UK National Standards body > The global role of BSI as the national standards body >
Careers > Events and conferences > Media centre/press room > Social responsibility > Modern slavery statement Contact us >
Popular topics BSI Medical Devices and Brexit > In Vitro Diagnostics revision > Medical Device Regulation revision > OBL / Virtual Manufacturers >
Upcoming Events BSI EU IVDR 2020 Roadshow > Join BSI experts at our In Vitro Diagnostic Regulation Workshop where you can learn about some of the most significant changes to the European Regulatory and Compliance requirements for CE marking.
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 new Regulations > European Commission Medical Devices guidance and legislation > European Commission Harmonised Standards > Central Management Committee Guidance > 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 > 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 Health Devices > European Enterprise and Industry: Medical Devices Sector > US Food and Drug Adminstration 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 >
