Guides and Advice

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

Blog, EU Regulations, Guides and Advice /

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 »

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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 »

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