The Medical Devices Regulation (MDR) is the legislation setting out the requirements that manufacturers must meet in order to market medical devices in the European Union. It affects all manufacturers, importers, distributors and representatives of medical devices within the EU. The MDR, which replaces the Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC), has a transition period of three years. Manufacturers have the duration of the transition period to update their technical documentation and processes to meet the new requirements.
The In Vitro Diagnostic Regulation (IVDR) describes the requirements that manufacturers must meet in order to sell IVDR devices within the European Union. The IVDR (EU) 2017/746 is the new EU legislation applicable to in vitro diagnostic (IVD) medical devices. Entering into force on the 25 May 2017 marking the start of a five-year transition period for manufacturers and economic operators, the IVDR replaces the EU In Vitro Diagnostics Directive (IVDD) 98/79/EC.
Would you like to comply with both legislation and customer requirements? Then BSI's MDR and IVDR training courses are suitable for you.