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.

Additional resources to support you

Use our resources to help you with the MDR.


Dedicated training courses

Dedicated training courses

At BSI we offer training courses tailored to the Medical Device Regulation to help support and grow your business.

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