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Road map relating to the extension introduced by the EU commission for the medical device regulations EU 2017/745. This road map details the new dates inline with when medical device classification types need to be in compliance with the regulation

MDR Article 120

Blog, EU Regulations, Guides and Advice, Patient Guard News, Standards / David Small

In the fast-paced world of medical device manufacturing, regulatory standards are the bedrock of patient safety and product quality. Recently, the European Union has taken a significant step by extending Article 120 of the EU Regulation 2017/745 and EU Regulation 2017/746. This move has been made to address the mounting backlog of CE mark certifications and re-certifications within notified bodies, the entities responsible for ensuring that medical devices meet stringent quality and safety requirements before they reach the market. In this blog post, we’ll delve into the implications of this extension for medical device manufacturers and emphasize the critical importance of continued compliance.

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The image shows a digital screen with light up in blue against a dark background are icons such as a tick, and a pad with a pencil next to it. The icons are in hexagons. In other light up hexagons are the words Quality Assurance . This image is used by Patient Guard to talk about their Medical Device and IVD Quality Assurance Services.

Medical Device QA Support: What are the benefits?

Blog, Client Questions / David Small

In today’s fast-paced and highly competitive business environment, ensuring the quality of your Medical Device products and services is paramount. Professional Quality Assurance (QA) support is the unsung hero that can help your business thrive. Whether you’re a start-up or an established enterprise, effective QA support can make a significant impact on the quality of your Management System and Devices. In this blog post, we’ll explore how professional QA support can benefit your business.

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A certificate that says 'ISO 13485 certified' on it - This image is used by patient guard to represent ISO 13485 quality assurance and QMS services.

What is ISO 13485? The Complete Guide to Medical Device QMS

Blog, EU Regulations, Guides and Advice, Medical Device Post-launch, Medical Device Pre-launch, Medical Device Validation, Quality Assurance, Quality Management, Standards, UK Regulations, USA Regulations / David Small

ISO 13485:2016 is the international standout standard that defines the precise requirements for a Quality Management System (QMS) specific to the medical device industry. Unlike general business quality frameworks, it prioritizes patient safety, clinical efficacy, and global regulatory compliance ahead of standard consumer satisfaction metrics.

Whether you are an active medical device manufacturer, a software-as-a-service (SaMD) developer, an importer, or an EU/UK distributor, demonstrating compliance with this standard is virtually mandatory to secure and retain critical market access.

What is ISO 13485? The Complete Guide to Medical Device QMS Read More »

global medical device and IVD registrations.

Medical Device & IVD registration

Blog, EU Regulations, UK Regulations, USA Regulations / David Small

Medical device registration is an essential part of commercialising your medical device or IVD. First requires you to obtain registration and approval from regulatory agencies in each country where you plan to sell your device. Device registration requirements can vary significantly from country to country, which can create compliance challenges for companies pursuing multiple-market strategies.

Medical Device & IVD registration Read More »

Image of a file with a cog and lines above it representing text. The cog represents technical information. The image is used by patient guard limited to discuss medical device technical files (EU 2017/745).

How to Structure a Medical Device Technical File

Blog, EU Regulations, Guides and Advice, Medical Device Pre-launch, UK Regulations / David Small

A medical device technical file is a concise set of documents created by a manufacturer to explain the performance and safety of a particular Medical Device in a clear, well-organized, easily searchable, and unambiguous manner.

In order to prove compliance with the general safety and performance criteria of the legislation, the manufacturer must have – and keep up-to-date – this technical documentation, regardless of medical device class.

How to Structure a Medical Device Technical File Read More »

IVD regulatory consultancy offered by Patient Guard in relation to the IVDR 2017/745

In Vitro Diagnostic Regulations (IVDR) – EU 2017/746

Blog, EU Regulations, Guides and Advice / David Small

In the ever-evolving landscape of healthcare, in vitro diagnostic (IVD) devices are indispensable tools, providing invaluable insights into patients’ health conditions. With the introduction of Regulation (EU) 2017/746, commonly known as IVDR, the European Union has implemented stringent regulations to ensure the safety, efficacy, and quality of these diagnostic instruments. As of May 26, 2022, this regulation has ushered in a new era, shaping the practices of manufacturers, healthcare professionals, and patients as they navigate the complexities of this comprehensive regulatory framework.

In Vitro Diagnostic Regulations (IVDR) – EU 2017/746 Read More »

Medical Device Consultancy

Blog, Patient Guard News / David Small

Medical device consultancy helps manufacturers navigate complex regulatory, quality and technical requirements throughout the product lifecycle. From early regulatory strategy and product classification through to Technical Documentation, ISO 13485, clinical evaluation, biological evaluation, validation, CE marking, UKCA compliance and post-market surveillance, the right consultancy partner can reduce risk, avoid costly delays and support successful market access.

Patient Guard provides specialist medical device consultancy services for manufacturers, start-ups, distributors and international companies placing devices on the UK, EU and global markets. Our team supports organisations with practical regulatory and quality assurance guidance designed to help bring safe, compliant and effective medical devices to market.

Medical Device Consultancy Read More »

image of a spy glass looking at graphs of data - image indicates patient guard as a medical device and IVD regulatory and quality assurance consultancy, with services such as post market surveillance.

Medical Device Software and AI – Revolutionizing Healthcare

Blog, Client Questions / David Small

Medical Device Software and artificial intelligence (AI) are not just buzzwords; AI is a transformative force that is reshaping the landscape of medicine and medical technology. Over the past decade, we have witnessed remarkable advancements in AI, and its impact on the medical device industry is nothing short of revolutionary. As we step into the next five years, the synergy between AI and medical devices is poised to usher in a new era of healthcare innovation, efficiency, and patient outcomes.

Medical Device Software and AI – Revolutionizing Healthcare Read More »

EUDAMED - European Database on Medical Devices

What is EUDAMED? A Complete Guide for Medical Device Manufacturers

Blog, EU Regulations, Quality Management, Standards / David Small

EUDAMED (European Database on Medical Devices) is the European Commission’s central database for medical devices and in vitro diagnostic medical devices placed on the European market under the Medical Device Regulation (EU) 2017/745 (MDR) and In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR).

The database improves transparency, traceability, vigilance, and market surveillance throughout the device lifecycle. As EUDAMED becomes increasingly mandatory, manufacturers, authorised representatives, importers, and notified bodies must understand how the system works and what information must be submitted.

This guide explains the purpose of EUDAMED, its modules, implementation timelines, and key compliance obligations for economic operators.

What is EUDAMED? A Complete Guide for Medical Device Manufacturers Read More »

Medical Device Regulatory Strategy for Startups: A Complete Guide (2026)

Blog, EU Regulations, Guides and Advice, Medical Device Post-launch, Medical Device Pre-launch, UK Regulations, USA Regulations / David Small

Launching a medical device startup can be an exciting journey, but regulatory requirements are often underestimated during the early stages of product development. Many start-ups focus on innovation, funding, and product design while leaving regulatory planning until later. Unfortunately, this approach can lead to significant delays, increased costs, and even project failure.

A well-defined regulatory strategy should be established as early as possible to ensure your medical device reaches the market efficiently while meeting all applicable regulatory requirements.

In this guide, we explain how medical device startups can build a successful regulatory strategy and avoid common compliance pitfalls.

Medical Device Regulatory Strategy for Startups: A Complete Guide (2026) Read More »

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