EU Regulations

Regulatory workspace illustrating EU MDR Article 120 transitional provisions, featuring a transition timeline, key MDR deadlines calendar, Regulation (EU) 2017/745 open to Article 120, legacy medical device technical documentation, ISO 13485 Quality Management System files, CE-marked medical device packaging, transition compliance checklist and project plan for MDR compliance.

EU MDR Article 120 Explained: Transitional Provisions and Extended Deadlines

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Article 120 of the EU Medical Device Regulation (MDR) introduced transitional provisions allowing certain legacy devices to remain on the market beyond the original MDR application date. However, these extended deadlines are only available to manufacturers that satisfy specific regulatory conditions. This guide explains how Article 120 works, which devices qualify, the current transition deadlines, what constitutes a significant change, and the practical steps manufacturers should take to maintain compliance under the EU MDR.

EU MDR Article 120 Explained: Transitional Provisions and Extended Deadlines Read More »

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 /

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 »

Infographic illustrating the different medical device registration pathways for the European Union, United Kingdom and international markets, showing the relationship between CE marking, EUDAMED registration, UDI assignment, MHRA registration, UK Responsible Person, Authorised Representative and international regulatory registrations including FDA and ARTG.

Medical Device Registration Explained: EU, UK and Global Requirements

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Medical device registration is not a single regulatory process. Depending on where you intend to market your medical device or IVD, you may need CE marking, MHRA registration, EUDAMED registration, UDI assignment or an Authorised Representative. This guide explains the different registration requirements under the EU MDR, IVDR and UK regulations, helping manufacturers understand which obligations apply before placing their products on the market.

Medical Device Registration Explained: EU, UK and Global Requirements Read More »

Hero image illustrating the structure of a medical device technical file under the EU MDR, showing the key documentation required for CE marking, including device description, General Safety and Performance Requirements (GSPRs), Risk Management File, verification and validation, Clinical Evaluation, Biological Evaluation and Post-Market Surveillance in accordance with Regulation (EU) 2017/745.

How to Structure a Medical Device Technical File

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

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 »

Illustration of Regulation (EU) 2017/746 (IVDR) showing laboratory diagnostics, CE marking and compliance requirements for in vitro diagnostic medical devices in the European Union.

Regulation (EU) 2017/746 Explained: The Complete Guide to the EU IVDR

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Regulation (EU) 2017/746, commonly known as the In Vitro Diagnostic Medical Device Regulation (IVDR), establishes the legal framework for placing in vitro diagnostic medical devices on the European Union market. It replaced the previous IVDD, introducing stricter requirements for clinical evidence, quality management systems, technical documentation and ongoing post-market surveillance.

Whether you manufacture laboratory diagnostics, companion diagnostics, self-tests or IVD software, understanding the IVDR is essential for achieving and maintaining CE marking. This guide explains the key requirements of Regulation (EU) 2017/746, helping manufacturers navigate compliance with confidence.

Regulation (EU) 2017/746 Explained: The Complete Guide to the EU IVDR Read More »

Illustration of the European Database on Medical Devices (EUDAMED) under the EU MDR and IVDR, showing the six interconnected modules—Actor Registration, UDI and Device Registration, Notified Bodies and Certificates, Clinical Investigations and Performance Studies, Vigilance, and Market Surveillance—supporting medical device transparency, traceability and patient safety across the European Union.

What is EUDAMED? A Complete Guide for Medical Device Manufacturers

Blog, EU Regulations, Quality Management, Standards /

EUDAMED (the European Database on Medical Devices) is the European Commission’s central database supporting the implementation of the Medical Device Regulation (EU) 2017/745 (EU MDR) and the In Vitro Diagnostic Medical Device Regulation (EU) 2017/746 (IVDR). It brings together information on manufacturers, medical devices, certificates, clinical investigations, vigilance activities and market surveillance into a single interconnected system.

By improving transparency, traceability and regulatory oversight, EUDAMED helps competent authorities, notified bodies, manufacturers and healthcare professionals access accurate information throughout the medical device lifecycle. This guide explains what EUDAMED is, how its six modules work together and why it has become an essential part of medical device regulatory compliance.

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

medical device consultancy

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 /

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 »

Professional reviewing medical device regulatory documentation, illustrating the role of the Person Responsible for Regulatory Compliance (PRRC) under Article 15 of EU MDR 2017/745 and IVDR 2017/746, including technical documentation, post-market surveillance and regulatory oversight.

Person Responsible for Regulatory Compliance (PRRC) under EU MDR & IVDR

Blog, EU Regulations, Patient Guard News /

The Person Responsible for Regulatory Compliance (PRRC) is a mandatory role under Article 15 of the EU Medical Device Regulation (EU MDR 2017/745) and In Vitro Diagnostic Medical Device Regulation (IVDR 2017/746). This guide explains who needs a PRRC, the required qualifications, key responsibilities, when the role can be outsourced, and how manufacturers can demonstrate compliance with regulatory requirements.

Person Responsible for Regulatory Compliance (PRRC) under EU MDR & IVDR Read More »

Medical Device Classification EU infographic showing the EU MDR classification hierarchy from Class I to Class III, explaining how device classification determines conformity assessment, clinical evidence, Notified Body involvement and the pathway to CE marking.

Medical Device Classification EU: A Practical Guide to MDR Classification Rules

Blog, EU Regulations /

Correctly classifying your medical device is one of the most important steps in achieving EU MDR compliance. Your device classification determines the conformity assessment route, clinical evidence requirements, technical documentation, Notified Body involvement and the pathway to CE marking. This guide explains the EU MDR classification rules, provides practical examples and helps manufacturers identify the correct classification for their medical devices.

Medical Device Classification EU: A Practical Guide to MDR Classification Rules Read More »

Illustration of an IVD Essential Requirements Checklist showing the transition from the IVDD Essential Requirements to the IVDR General Safety and Performance Requirements (GSPRs) for in vitro diagnostic medical devices.

IVD Essential Requirements Checklist: Transitioning to IVDR GSPRs

Blog, CE Marking, Client Questions, EU Regulations /

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 Essential Requirements Checklist: Transitioning to IVDR GSPRs Read More »

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