
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.
This guide can help you when preparing and structuring your Technical Documentation
Our guide to the certification process for the MDR
This resource will help you understand the conformity assessment routes
This FAQ document aims to answer some key questions on the MDR
Use our resources to help you with the MDR.
Learn more about our training courses, available dates and booking options
We offer a wide range of free and live webinars hosted by BSI Technical Specialists addressing key topics that affect your business including legislation, risk, and regulatory changes.
Our white papers will help you understand how to perform better, reduce risk and make excellence a habit in your organization.
At BSI we offer training courses tailored to the Medical Device Regulation to help support and grow your business.