When a manufacturer provides a medical device to the market, the manufacturer has to supply information with the device. As this is defined in EN 1041, this standard will soon be replaced by ISO 20417 currently in the publishing state. Read here what you need to know.
As ISO 20417 is prepared by the Technical Committee TC/210, the same TC which manages ISO 13485 Medical devices — Quality management systems —Requirements
for regulatory purposes as well as ISO 14971 Medical devices — Application of
risk management to medical devices, it is assumed that the new standard ISO 20417 is well balanced between the requirements of the other TC/210 managed standards.
What is ISO 20417 about?
ISO 20417 is intended to replace EN 1041 and thus, the aim is to provide a single source of the common, generally applicable requirements. The standard shall define and cover the following information which is:
- to be supplied on the label
- to be provided on the packaging
- in the instructions for use or technical description
- otherwise required to be supplied with the medical device or the medical device accessory
A central aspect of the information covered by the ISO 20417 are technical descriptions provided by the manufacturer. Here, a possible source for such information might be the website or marketing material, which includes:
- data that is essential for safe use
- data on transport and storage
- information on maintenance or repair
- information on measures or conditions necessary for installation of the medical device
- information for the preparation of the medical device for use
what is covered by ISO 20417 ?
The standard covers the articles on the information supplied by the manufacturer:
- general process requirements
- focus on the information supplied by means of
- expression of units of measure
- identification of countries and languages
- expression of dates
- expression of addresses, e.g. of the legal manufacturer or the EC REP
- reference, product or catalogue number
- versioning of software releases
- control of manufacturing processes
- consistent and clear indication of use
- sterility indication
- definition of information accompanied with the medical device or accessory, e.g. packaging, label, marking, instructions for use, technical descriptions and use information
why should you care?
ISO 20417 marks new milestone in standardizing and harmonizing the labeling of medical devices and accessories. This is realized by clearer information and requirements provided to the reader and ultimately to the manufacturer. Further, ISO 20417 is well balances among ISO 13485 and ISO 14971 making it a central pillar of the general aspects and the quality management of medical devices.
How Avanti Europe can help
Avanti Europe’s Experts have a decade-long track record and expertise in consulting and contracting to the Medical Device industry. Our experts support your company with hands-on workforce and support the definition of the QMS, the labeling of the product, processes, the documentation, training for the company staff, and audits for Medical Device QMS, and Supplier audits. Visit our online shop for checklists and other services.