Practical perspectives on medical device regulation
Insights to navigate regulation, bring medical technologies to market, and improve patient care.
EU Authorised Representative
Navigating the complexities of EU medical device regulations is crucial for manufacturers, particularly those outside the European Union.
Declaration of Conformity Template: UK and EU
Free declaration of conformity templates for UK and EU medical devices, with guidance on what each version requires.
What Is a Class 1 Medical Device?
An accessible explanation of Class 1 medical device classification under EU MDR, including registration and QMS requirements.
Internal Audit Report Template for ISO 13485
A practical internal audit reporting template for ISO 13485, with guidance on structure, findings and follow-up actions.
How to Identify the Legal Manufacturer for Medical Devices
A clear guide to identifying the legal manufacturer of a medical device under EU MDR and UK regulations.
Example Quality Objectives for ISO 13485
Practical examples of quality objectives for medical device manufacturers, aligned to ISO 13485 and MDR expectations.
Is ISO 13485 Required for CE Marking?
A clear answer on whether ISO 13485 certification is required for CE marking medical devices under EU MDR.
How to Make Internal Audits Work for You, Not Against You
How to build an ISO 13485 audit schedule under clause 8.2.4 that reflects real risk, instead of repeating the same audits every year.
Quality & Regulatory Essentials for Medical Devices
Core quality and regulatory concepts every medical device professional should understand, explained clearly and practically.
EU Regulation 2024/1860 and Device Shortages
What EU Regulation 2024/1860 means for medical device availability and what manufacturers and economic operators should know.
Regulatory Compliance Strategy for EU MDR
A practical approach to building a regulatory compliance strategy under EU MDR, from classification to post-market obligations.
ISO 13485 Internal Audit Training Guide
Practical ISO 13485 internal audit training guidance. Understand what auditors look for and how to prepare your team.
Documents of External Origin: Do I Have to Revalidate?
A grounded look at when revalidation of external documents is required under ISO 13485 and what regulators expect.
UK Medical Devices Regulations: Latest Updates
The latest on UK medical device regulations, including MHRA timelines, transitional arrangements and what to act on now.
Cybersecurity within Medical Devices
An overview of cybersecurity requirements for medical devices under MDR and IEC 62304, and what manufacturers need to address.
Are Harmonised Standards Mandatory? MDCG 2021-5
MDCG 2021-5 Rev 1 confirms using a standard is voluntary, but notified bodies can still assess against one you haven't applied.
Mental Health Medical Devices: A Regulatory Overview
How digital mental health technologies fit existing medical device regulations, from borderline classification to risk management and clinical evidence.
MHRA International Recognition of Medical Devices and the AI Airlock
How the MHRA's international recognition framework and AI Airlock sandbox affect UK market access for AI-enabled devices.
Sterilisation Master File Template
A free sterilisation master file template for Class I medical device manufacturers, built around real regulatory expectations.
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