MDR best practice guidelines
Download our MDR Best Practices Guidelines to help you prepare and structure your Technical Documentation when planning your application to BSI for a conformity assessment of a medical device under the MDR.
The new European Medical Device Regulation (MDR) was published in the Official Journal of the European Union and entered into force on May 25, 2017, marking the start of the transition period for manufacturers selling medical devices into Europe.
As a manufacturer of a medical device, you must ensure that you meet the relevant regulatory requirements before placing your product onto the market; for the EU, these are outlined in the Medical Device Regulation (MDR) (EU) 2017/745 and, for the UK, the UK Medical Devices Regulations (UK MDR) 2002.
Use our resources to help you with the MDR.
At BSI we offer training courses tailored to In-Vitro Diagnostics to help support and grow your business.