Tracking medical device standards

Posted on 24/04/2017

Do you work in an area of the healthcare products industry where you have to consider medical device regulations and standards as part of your product’s regulatory pathway to market? Have you ever wondered which standards you should be applying and how their development and implementation timelines may affect your product? Would you like to help develop the next standard for your company’s product?

In the February 2017 issue of Regulatory Rapporteur, we published our inaugural “Medical Device Standards Update” column, tracking key device standards. The second update is published in our May edition, and summarises the current status of key horizontal standards and regulations relating to devices and in vitro diagnostics (IVDs). This information is provided in a table which focuses on those devices and IVDs which have reviews pending or are circulated for public comment.

Following the adoption of the European Commission’s two legislative proposals on devices and IVDs on 5 April, we are now publishing a complete list of all horizontal standards on our website. To view the full listings, and future updates throughout the year, log on to the MedTech SPIN online community via My TOPRA* (if you aren’t already a member of the MedTech SPIN, simply go to the My Activity page to join*).

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