EU Regulations

EUDAMED - European Database on Medical Devices

What is EUDAMED? A Complete Guide for Medical Device Manufacturers

Blog, EU Regulations, Quality Management, Standards /

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.

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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.

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Medical Devices Classification - This is an illustration of a hand under an x-ray. The hand shows the bones of the hand. This image is used by patient guard to demonstrate an example of a class IIb medical device.

Medical Device Classification EU

Blog, EU Regulations /

In the EU Medical Devices are categorised into 7 classes, these are Class I, Class Is (sterile), Class Im (measuring), Class Ir (reusable surgical tools), Class IIa, Class IIb and Class III.  

Class I devices are considered to be of low risk, Class II devices as medium risk and Class III devices as high risk. 

Depending on the classification of device determines the regulatory conformity pathway that needs to be taken to gain compliance and allow manufacturers to place product on the EU market. 

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IVD

IVD Directive Essential Requirements vs. IVDR GSPR: How to Transition Your Checklist

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 Directive Essential Requirements vs. IVDR GSPR: How to Transition Your Checklist Read More »

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