Notes on standards changes, market rules and practical compliance work.
This section collects short articles on regulatory developments that affect product makers and trading businesses. Each piece explains what has changed, who is affected and what a practical response looks like.
Topics include revisions to harmonised standards, updates to labelling and marking rules, and the documentation expected at assessment. We write for engineers, quality managers and business owners who need a clear reading of the rules without the legal jargon.
Published articles will be added below this introduction in date order.
Each article states the rule, the date it applies from and the evidence most often requested. Where a standard is still in draft, we say so.
Leave your email address and we will let you know when a new article is published.
For service details, see regulatory services.
Who Devices for Dignity Ltd Actually Is Devices for Dignity Ltd is the commercial arm of the NIHR HealthTech Co-operative hosted in Sheffield. In plain English, it is the tradin…