In this page it is possible to download the first checklist for labelling requirements according to EU MDR 2017/745.
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; 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 a detailed checklist listing all the requirements related to labelling, information for use and packaging according to EU MDR 2017/745. This checklist helps to have all the requirements under control and provide an efficient method for their implementation, to ensure to respond to all the requirements mentioned in the European Medical Device Regulations.
With the QualityMedDev E-book on Labelling Requirements for Europe and United States, this checklist represents the perfect tool for the implementation of labelling, IFU and packaging requirements.
Here at QualityMedDev we show the first checklist for labelling requirements according to EU MDR.
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