Over the past months, the UK Medicines and Healthcare products Regulatory Agency (MHRA) opened a consultation on the current UK Medical Devices Regulations 2002. For those familiar with the UK MDR 2002, it is very similar to the old EU directives. Thus for medical device manufacturers less familiar with the UK MDR 2002, the current regulation is equivalent to the European Union’s Medical Devices Directive (MDD 93/42/EEC) and In-vitro Diagnostic Medical Devices Directive (IVDD 98/79/EC). So market entrance in the UK would require you to pull up your old MDD or IVDD Technical File again…
