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 25 May 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.
Learn more about the Medical Device Single Audit Progam.