ISO 15223-1:2021/Amd 1:2025 and what it means for you
As many industry stakeholders may be aware, an amendment to ISO 15223-1:2021 was released last month. This update has generated some uncertainty among manufacturers regarding its implications and the necessary next steps. This article aims to clarify the key elements of the amendment and provide practical guidance on how to respond. It is important to ...
Labelling Under the MDR
A label provides a wealth of information regarding your medical device that is communicated to the end user or patient. Therefore, it is of utmost importance that you have all the relevant information on the label as laid out in Annex I Section 23 of the MDR. Annex I 23.1 (h) states that; Where appropriate, ...
Medical Device Technical Document Compilation
The need for a detailed Technical File, i.e. the complete technical documentation needed to demonstrate that a particular Medical Device, or In-Vitro Diagnostic Medical Device, conforms to the regulations and is safe to place on the market, is essential for all devices, even those that are for low-risk. As part of their key obligations under ...
Gap Analysis/Technical File Review
The legal manufacturer is responsible for making sure their technical documentation is up to date and compliant. If your files were prepared according to the Directives, if some time has passed, or new applicable standards have been released that you rely on for compliance, you should review your files. If you, as the legal manufacturer, ...
Compliance with Language Requirements
Any information provided by a manufacturer must be understood by the intended end-user so as to ensure that their device can function safely and perform as intended. This could be a problem when selling into the European Union (EU) / European Economic Area (EEA) which is currently made up of 27 EU countries, plus 4; ...
