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 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 ABHI Association of British Healthcare Industries MDMA Medical Device Manufacturers Association BIVDA British In Vitro Diagnostics Association