MEDICAL DEVICES | INFORMATION SUPPLIED BY MANUFACTURER

Last April, the first edition of ISO 20417:2021: Information to be supplied by the manufacturer - medical devices was published.

Last April, the first edition of ISO 20417:2021: Information to be supplied by the manufacturer - medical devices was published.
December 13, 2021

Last April, the first edition of ISO 20417:2021: Information to be supplied by the manufacturer – medical devices was published:

  • This standard replaces the former withdrawn technical standard ISO 1041: Information supplied by the manufacturer of medical devices, and provides the requirements for the identification and labels on a medical device or accessory, the packaging, marking of a medical device or accessory, and accompanying information.
  • In the context of its publication, it is a technical standard that helps manufacturers comply with most of the requirements set by Regulation (EU) 2017/745 with regards to information provided by the manufacturer. It also addresses legibility of the labelling in further detail and proposes how to assess it.

At Asphalion, we can give you support in ensuring that all your products comply with this standard.

For further information you can contact us at: info@asphalion.com

 

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NEWS | Proposed framework for International Recognition of Medical Devices by MHRA

This statement describes the draft policy for recognition by the UK of international regulators’ approvals of medical devices.
This statement and proposed framework applies to medical devices in Great Britain. For guidance on the regulation of devices in Northern Ireland, see Regulation of devices in Northern Ireland.

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