Navigating the complexities of EU medical device regulations is crucial for manufacturers, particularly those outside the European Union.

Registering medical devices in the UK is essential for manufacturers aiming to market their products in Great Britain (England, Scotland, and Wales).

This guide provides an in-depth overview of Turkey's medical device regulations, insights into importing and exporting devices, and references to trade agreements with key global markets, including the EU, UK, USA, and Canada.

A comprehensive overview of QMSR, its alignment with ISO 13485, the role of consensus recognised standards, and actionable strategies for manufacturers to prepare for compliance.

We break down the role of a UKRP, why it’s essential for compliance, and what to look for when choosing the right one for your business.

If you’re a medical device manufacturer looking to market your products in the UK or EU, preparing a Declaration of Conformity (DoC) is a critical step in the regulatory process.

A Class 1 medical device represents the lowest risk category of medical devices. Despite being classified as low risk, these devices are still subject to regulatory oversight to ensure their safety, performance, and compliance with relevant standards.

An effective internal audit report is more than just a tick in the box. It's a valuable tool that offers insights into your organization's processes, pinpoints areas for improvement, and fuels continuous growth.

The term “Legal Manufacturer” is one that has been floated about a lot in the last few years. However, it is not actually defined anywhere in EU legislation.

As per the requirements of ISO 13485, 9001 and any ISO standard as a result of Annex SL - all quality systems in line with this require the establishment of Quality Objectives.

ISO standards can be expensive. As can the certification towards them. Leading to the question, are they mandatory? We outline some of the key documents and salient points that manufacturers can use.

This is a list of my Quality and Regulatory Essentials as a Medical Device Regulatory Consultant.

As a result of EU Regulation 2024/1860, Manufacturers must inform the ANSM when the unavailability of the MDs or IVDMDs that they manufacture and/or place on the market, linked to a shortage, a risk of shortage, or a marketing stoppage, may create a risk situation in the management of the patient's state of health.

The Strategy for Regulatory Compliance is a requirement that has came very specifically as a result of MDR and IVDR, which begs the question, what should be the scope of the strategy for regulatory compliance?

A very common non-conformance we see is organisations that do not have completed ISO 13485 training, or adequately competent auditors to conduct audits on their ISO 13485 Quality Management System.

When a harmonised standard is revised, the answer to whether you need to revalidate your processes isn't straightforward - but a gap assessment between your QMS and the updated standard is always a good place to start.

The MHRA is moving towards international recognition of medical device approvals from comparable regulators including the EU, FDA, Health Canada and TGA, while also pioneering the AI Airlock, a world-first regulatory sandbox to support the safe development of AI as a medical device.

Using the "Swiss cheese" layers of defence model, this post breaks down how cybersecurity risk should be built into medical device design, from security policies through to penetration testing, in line with EU MDR information security requirements.