Medical Device Labelling Requirements: FDA and EU MDR 2017/745 Regulations

Medical Device Labelling Requirements: FDA and EU MDR 2017/745 Regulations


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Labelling has always been an essential topic for medical device sector and in the last years, with the upcoming new EU MDR, the labelling requirements became more and more stringent; moreover, the attention placed by the FDA for medical device labelling has always been very high: labelling materials have a direct impact on safety of the device on the market, thus safety of the patients.

For all these reasons, a full and in depth understating of these requirements for all the main different markets is becoming more and more necessary within any quality management system compliant with ISO 13485,  FDA regulations and regulations from other countries.

With the new EU MDR 2017/745 soon coming to life, labelling requirements and information to be provided by manufacturer (IFU) became more and more complex, due to the increase number of specific requirements to be met.

Moreover, the new European regulation brought to life new amendments of labelling related ISO standards or even completely new standard (for example ISO 20417). For example, for the information for use, the  requirements mentioned in the EU MDR 2017/745 are definitely more stringent than the one mentioned in the MDD or in FDA regulations.

Here we present an e-book that explains the medical device labelling regulations according to FDA and EU MDR 2017/745. This document represents a comprehensive overview of medical device labelling regulations in the EU and US market.

There has been the necessity of one unique document that would explain and discuss all at once all the medical device labelling requirements for the main countries: Europe and United States.

Specifically, the topics covered by the e-book are:

  • Information to be provided in the Instructions for Use according to EU MDR 2017/745
  • Labelling Requirements according to EU MDR 2017/745
  • ISO 15223-1:2021 new symbols for medical devices
  • FDA Labelling Requirements: An Overview
  • ISO 20417:2021 : New ISO Standard on Information to be Provided by Manufacturer
  • FDA Requirements for UDI on Medical Devices

As can be seen, the e-book covers the most recent regulations and ISO standards for labelling, including the explanations for the new symbols for ISO 15223-1:2021 (currently still under development) and the new ISO 20417.

Here at QualityMedDev we have the first comprehensive review of labelling requirements for EU and US regulations.

Do not hesitate to download the e-book!

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