MDR Medical Device Regulation

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.


MDR documentation submission

Download our MDR best practices guidelines to help you prepare and structure your Technical Documentation when planning your MDR conformity assessment application to BSI.


MDR conformity assessment routes

Our guiding brochure will support you in understanding conformity assessment routes and in selecting the most suitable for your medical device.


Clinical Masterclass Series

Our webinar series is back!

Join us for part 2 of our Clinical Masterclass Series in 2023 and listen to our experts discuss various aspects of the MDR. From preparing a Clinical Evaluation Plan, to supporting you with preparing a Clinical Evaluation Report, advice on PMCF and SSCP and much more.