Planning to place a medical device on the US market? This complete guide explains FDA medical device regulations, including device classification, 510(k), De Novo and PMA pathways, QMSR and ISO 13485, establishment registration, device listing, U.S. Agent requirements, UDI and post-market obligations.
FDA Medical Device Regulations: A Complete Guide for Manufacturers Read More »
Preparing to sell digital health technology to the NHS requires more than completing DTAC. This guide explains how manufacturers can build a procurement-ready position by aligning regulatory compliance, clinical safety, data protection, cybersecurity, interoperability, accessibility and commercial evidence for NHS market access.
How to Become NHS Procurement Ready: From DTAC to NHS Market Access Read More »
For digital health manufacturers preparing to enter the NHS, clinical safety can be one of the most important—and sometimes misunderstood—parts of DTAC.
It is not enough to demonstrate that your software works.
Manufacturers need to consider what could happen if the technology fails, produces incorrect information, presents information incorrectly, contributes to a workflow error or is used in circumstances that could expose patients to harm.
This is where clinical risk management and DCB0129 become particularly important.
NHS England identifies DCB0129 as the clinical risk management standard for manufacturers of health IT systems. Its counterpart, DCB0160, applies to health organisations deploying and using health IT systems. NHS England states that compliance with these standards is required under the Health and Social Care Act 2012.
For manufacturers working towards NHS DTAC readiness, understanding the distinction—and having the right clinical safety evidence—is essential.
DCB0129 and Clinical Safety: What Digital Health Manufacturers Need for NHS DTAC Read More »
If your digital health technology is heading towards the NHS, understanding the Digital Technology Assessment Criteria (DTAC) should be part of your market-access planning.
But one of the biggest mistakes manufacturers can make is treating DTAC as simply another questionnaire to complete.
The questions are only part of the process.
Behind your answers needs to be evidence showing that your technology and organisation have appropriate arrangements for clinical safety, data protection, technical security, interoperability, and usability and accessibility.
These five areas form the core of NHS DTAC. NHS England describes DTAC as national baseline criteria for digital health technologies entering NHS and social care.
For digital health manufacturers, the practical question is therefore not simply:
“Can we complete the DTAC assessment?”
It is:
“Can we demonstrate that our product meets the requirements?”
This guide looks at each of the five DTAC areas, the types of evidence manufacturers should consider and some of the common gaps that can delay NHS readiness.
DTAC Requirements Explained: The 5 Areas Digital Health Manufacturers Need to Get Right Read More »
A complete guide to NHS DTAC compliance for digital health manufacturers, covering the five DTAC assessment areas, required evidence, clinical safety, data protection, technical security, interoperability and usability, and how to prepare your digital health technology for NHS procurement.
The Complete Guide to NHS DTAC Compliance for Digital Health Manufacturers Read More »
Before a cosmetic product can legally be placed on the UK market, manufacturers and Responsible Persons must demonstrate that it is safe for human use under normal or reasonably foreseeable conditions. The Cosmetic Product Safety Report (CPSR) is one of the most important regulatory documents required under the UK Cosmetics Regulation. This guide explains what a CPSR is, who can prepare one, what information it must contain, how it relates to the Product Information File (PIF) and how it supports legal cosmetic compliance.
Cosmetic Product Safety Report (CPSR): A Complete Guide to UK Cosmetic Compliance Read More »
Post-Market Performance Follow-up (PMPF) is a fundamental requirement under the EU In Vitro Diagnostic Regulation (IVDR), ensuring that manufacturers continually monitor the scientific validity, analytical performance and clinical performance of their in vitro diagnostic medical devices after CE marking. This guide explains IVDR PMPF requirements, PMPF Plans, PMPF Reports, Annex XIII expectations and how ongoing performance monitoring supports continued regulatory compliance throughout the device lifecycle.
IVDR PMPF Explained: A Complete Guide to Post-Market Performance Follow-up Read More »
Scientific Validity is the first pillar of IVDR Performance Evaluation and provides the scientific foundation demonstrating that an analyte or biomarker is associated with a specific clinical condition or physiological state. This guide explains Scientific Validity under Regulation (EU) 2017/746, including literature reviews, Scientific Validity Reports, Annex XIII requirements, evidence appraisal and how Scientific Validity supports successful CE marking.
IVDR Scientific Validity Explained: A Complete Guide for Manufacturers Read More »
Performance Evaluation is one of the most important requirements under the EU In Vitro Diagnostic Regulation (IVDR). Every manufacturer must demonstrate that their in vitro diagnostic medical device achieves its intended purpose through robust scientific validity, analytical performance and clinical performance evidence. This guide explains every stage of IVDR Performance Evaluation, including Performance Evaluation Plans (PEPs), Performance Evaluation Reports (PERs), Post-Market Performance Follow-up (PMPF) and how Performance Evaluation supports successful CE marking under Regulation (EU) 2017/746.
IVDR Performance Evaluation Explained: A Complete Guide for Manufacturers Read More »
Understanding how your in vitro diagnostic device is classified under the EU IVDR is one of the first and most important steps towards regulatory compliance. This guide explains the IVDR classification rules, the differences between Class A, B, C and D IVDs, how Annex VIII is applied, and how classification affects conformity assessment, technical documentation and Notified Body involvement.
IVDR Classification Explained: A Complete Guide to Class A, B, C and D IVDs Read More »
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