Learn how UK medical device regulations work, including UKCA marking, MHRA registration, UK Responsible Person (UKRP) requirements, classification, post-market surveillance and the latest regulatory reforms affecting manufacturers.
Regulating Medical Devices in the UK: The Complete Compliance Guide Read More »
Navigating Article 15 Qualifications, Outsourcing Rules, and Current Audit Realities
Person Responsible for Regulatory Compliance (PRRC) under EU MDR & IVDR Read More »
In the EU Medical Devices are categorised into 7 classes, these are Class I, Class Is (sterile), Class Im (measuring), Class Ir (reusable surgical tools), Class IIa, Class IIb and Class III.
Class I devices are considered to be of low risk, Class II devices as medium risk and Class III devices as high risk.
Depending on the classification of device determines the regulatory conformity pathway that needs to be taken to gain compliance and allow manufacturers to place product on the EU market.
Medical Device Classification EU Read More »
In the UK Medical Devices are categorised into 7 classes, these are Class I, Class Is (sterile), Class Im (measuring), Class Ir (reusable surgical tools), Class IIa, Class IIb and Class III.
Class I devices are considered to be of low risk, Class II devices as medium risk and Class III devices as high risk.
Depending on the classification of device determines the regulatory conformity pathway that needs to be taken to gain compliance and allow manufacturers to place product on the UK market.
Medical Devices Classification UK Read More »
Don’t confuse QA and QC in your QMS. Discover the critical differences between Quality Assurance and Quality Control under ISO 13485, and learn how balancing both protects your device and your next audit.
Quality Assurance vs. Quality Control in Medical Devices Read More »
The shift from the In Vitro Diagnostic Directive (IVDD 98/79/EC) to the In Vitro Diagnostic Regulation (IVDR EU 2017/746) represents a fundamental overhaul of how technical files are structured. Under the legacy Directive, manufacturers relied on an Essential Requirements Checklist to demonstrate safety and performance. Under the IVDR, this has been completely replaced by the General Safety and Performance Requirements (GSPRs) found in Annex I.
If you are updating a legacy device technical file or migrating a quality management system, you cannot simply copy and paste your old compliance arguments. The GSPRs require a much higher degree of clinical evidence, lifecycle risk tracking, and technical specificity.
IVD Directive Essential Requirements vs. IVDR GSPR: How to Transition Your Checklist Read More »
A robust Quality Management System (QMS) isn’t just an administrative requirement—it is a strategic blueprint for scaling your operations and reducing risk. Whether you are establishing a foundational framework under ISO 9001 or navigating the specialized, compliance-heavy requirements of medical device sectors, understanding how a QMS drives efficiency is critical. Explore the 10 core business benefits of implementing a world-class quality framework and the step-by-step path to achieving accredited certification
The Benefits of ISO 9001 Quality Management System Read More »
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