MHRA：英国の医療機器規制

Who regulates medical devices in the UK? The MHRA. But Great Britain follows the UK MDR 2002, while Northern Ireland follows the EU MDR and IVDR. In Great Britain, you don't need UKCA yet: CE marking is still accepted. EU MDR and IVDR devices until June 30, 2030. MDD and AIMDD devices until June 30, 2028, or earlier if the certificate expires. If you're based outside the UK and sell in Great Britain, appoint one UK Responsible Person for all your devices. They register every device with the MHRA before it goes on the market, and keep your technical documentation ready for inspection. Since June 16, 2025, Great Britain's post-market rules are stricter. Report serious incidents within 15 days, 10 for a death, and 2 for a serious public health threat. Start with three things. One: appoint your UK Responsible Person. Two: register every device with the MHRA. Three: check each CE certificate against the 2028 and 2030 dates. Same country, different rulebooks. Pure Global covers registration, in-country representation, quality systems, audits and cybersecurity, in more than 30 markets. Visit pureglobal.com.