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Regulatory updates

News and guidance on EU and UK regulations for medical devices, IVDs and general products. The newest posts are shown first.

All updates · EU MDR & IVDR · EUDAMED · UK & MHRA · Standards · Product safety / GPSR · Software & data

Crafting the Perfect Intended Purpose for SaMD: A Step-by-Step Guide to Regulatory Success

How to write a clear intended purpose for software as a medical device, step by step.

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Software & dataGuest UserMay 23, 2024Comment
Harmonised Standards, March 2024 Updates

Harmonised standards published 8 March 2024, including EN 455-3:2023 for medical gloves and EN ISO 10993-15:2023.

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StandardsGuest UserMay 22, 2024Comment
Comprehensive Overview of Changes in EN 60601-1 Medical Device Safety Standards (2006-2024)

How EN 60601-1, the safety standard for electrical medical equipment, changed between 2006 and 2024.

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StandardsGuest UserMay 16, 2024Comment
Proposed Post-Market Surveillance (PMS) Enhancements UK

The UK's proposed post-market surveillance rules: tighter reporting of adverse events and safety data.

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UK & MHRAGuest UserMay 16, 2024Comment
Small but significant changes to both ISO 9001 and ISO 14001

Amendment 1:2024 adds climate change considerations to ISO 9001 and ISO 14001. Small changes, but auditors will look for them.

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StandardsGuest UserMay 14, 2024Comment
UK Medical Device and In-Vitro Diagnostic Medical Device Regulations

MHRA guidance on the UK Medical Devices Regulations 2002 for Great Britain: what the rules require.

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UK & MHRAGuest UserMay 9, 2023Comment
IVDR Progressive Rollout...hopefully means most of the industry can survive the transition

The Commission's 2021 proposal for a progressive IVDR rollout gave the industry more time. What it meant.

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EU MDR & IVDRGuest UserOctober 14, 2021Comment
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EU-UK Authorised Representative Limited is a subsidiary of BS Partnership Limited. Registered in Northern Ireland, company number NI674577. Registered office: 54 Bloomfield Avenue, Belfast BT5 5AD.

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