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The EU’s Medical Device Regulation (MDR) went into force

Starting from May 26th!

The EU’s Medical Device Regulation (MDR) went into force

The Medical Device Regulation is the new law for the certification and marketing of medical devices in the European Union. Starting from May 26, 2021 this new law has replaced the (old) Medical Device Directive!

To help you in achieving and keeping compliance, you can download our ‘readable’ and indexed version of the MDR here. Medical laws and regulations are complex. Certification is a difficult and time-consuming task for many companies. We know the guidelines inside out and are experts in the field of technical documentation.

Do you need any support implementing the MDR requirements into your system and product files? Or do you have any other medical device related questions? Feel free to contact our regulatory team.

The MDR readable edition is offered to you free of charge. We will not use your personal data.