A new standard is expected to be published in early 2021: it is named ISO 20417 Medical devices — Information to be supplied by the manufacturer and it will define the regulatory requirements to be provided by MedTech manufacturers in the labelling of devices.
The Technical Committee ISO/TC 210 was the responsible for the development of this standard; it is the same technical committee that has developed other key medical device standards such as ISO 13485 and ISO 14971.
This new standard follows a parallel process for harmonisation and it will be publish as ISO and EN ISO standard. Specifically, the EN ISO version will contain the annexes ZD and ZE to allow to link the standard with the requirements of EU MDR 2017/745 and EU IVDR 2017/746.
This New ISO 20417 will replace the standard EN 1041:2008, that has been harmonised to link the requirements of the previous Medical Device Directive and Active Implantable Medical Device Directive.
Several inputs have been used for the preparation of the New ISO 20417, including documents from the International Medical Devices Regulators Forum (IMDRF) such as Essential Principles of Safety and Performance of medical devices and in vitro diagnostic (IVD) medical devices and principles of labelling for medical devices and IVD medical devices.
The goal of the ISO 20417 is to provide a guideline for the generally applicable requirements related information supplied by manufacturers for medical devices and accessories, allowing then each specific product-related standard to focus more concisely on the unique device for the specific medical device product category
ISO 20417 covers different types of information to be provided by the manufacturer. Specifically:
- information to be supplied on the label
- Information to be provided on the packaging
- Information to be included in the instructions for use and technical description
- information otherwise required to be supplied with the medical device or accessory
The ISO 20417 is currently at the end of the development process and its publication is expected within 2020. Together with the newly updated standard on risk management, manufacturers will have important tools to foster safety of the devices on the market.
ISO 20417 Medical devices — Information to be supplied by the manufacturer will be an important regulatory standard for MedTech manufacturers to fully define the labelling requirements.
Going more in details on the contents of the ISO 20417, the standard provides detailed requirements on the following:
- Information on the elements and symbols to be provided on the Information for Use, labels and other accompanying information documents. This includes explanation on the format and symbols associated to this information (date, lot number, address,UDI, etc).
- Requirements for accompanying information, that includes requirements for label, including legibility and durability, requirements for IFU and technical descriptions, and packaging requirements.
- Other requirements for specific entities like importers and distributors and for activities like repackaging and translation of the IFU.
In the framework of harmonisation of existing standards to the EU MDR 2017/745 and IVDR 2017/746, also the ISO 15223-1 is going to be revised, to include the requirements European Medical Device and In Vitro Diagnostic Regulation symbols to be used in labels.
ISO 20417 Compliance Checklist
QualityMedDev has published a ISO 20417 Compliance checklist to help manufacturers to make sure to fulfil all the requirements associated to labelling, packaging and accompanying documents. This checklist is an essential tool to ensure that your labelling, IFU and other accompanying information materials are compliant with ISO 20417 and Includes all the requirements mentioned in the ISO 20417 in a fully editable excel file of 32 pages. For simplification, requirements mentioned in the ISO 20147 that were not considered mandatory by the ISO commitee were not included in the checklist.
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