The Team-NB guide “Software Qualification Under IVDR: TeamNB Guidance on IVD Software Classification and Notified Body Expectations” (v2, June 2025) provides practical clarification on the qualification and classification of in vitro diagnostic software (IVD) under Regulation (EU) 2017/746 (IVDR).
Unannounced audits are a key element of post-certification surveillance for medical devices under European regulations (MDR 2017/745 and IVDR 2017/746). As a notified body, GMED.
[article originally published on June 19, 2025, updated with the publication of Regulation (EU) 2025/1234] Implementing Regulation (EU) 2021/2226, which regulates the electronic supply of.
Analysis of borderline devices: medical device status and class under Regulation (EU) 2017/745
Opinions of expert groups in the clinical evaluation of medical devices
Swiss Medtech sector study 2022, impact of the 2017/745 regulation
Comparison of Notified Body fees in the context of the european regulation on medical devices
Definitions of nanomaterial, particle, aggregate, and agglomerate.
This article’s objective is to clarify the Standards’ references. As you will have noticed from your research: the names of the standards are difficult to grasp and the explanations are not easy to find. This article gives the definitions of the main terms, using information from ISO where available.
Risks: definitions, major types and management methods. General guide, applicable to all risks (health, climate, professional, etc.)
This article presents the “philosophy” of the 7 principles of quality management. Each principle is illustrated with a quote, for ease of understanding.
This article proposes to summarize the High Level Structure for management system standards
The 5S method was formalized in the industrial workshops of Toyota, to allow improving the organization of a workspace.
Principles and calculations for process validation: capability coefficients, standard deviation, centering, error, number of samples required, etc.
Summary of PMCF requirements: Post-Market Clinical Follow-up of medical devices, according to Regulation 2017/745 (definition, methods, expected documents…)
Guidance on the implementation of Regulation (EU) 2017/745 on medical devices, particularly for manufacturers.
Presentation of the Periodic Safety Update Report for medical devices (PSUR) required by the Medical Device Regulation (UE) 2017/745
This article gives the state of the art in Cybersecurity of Medical Devices, to provide a overall view of a cybersecurity management process.
IEC 62304 Medical device – Software life cycle defines the life cycle requirements for medical device software, the set of processes, activities, and tasks described in this standard.
Summary of the standard IEC 62366-1 Medical devices Usability engineering: examples and methods.
Introduction to the clinical evaluation of medical devices and corresponding regulatory requirement to obtain and maintain the CE marking
Post-marketing surveillance process and phases
Summary of the XP S99-223 standard on the management of the benefit/risk ratio of medical devices for regulatory purposes
Roles and obligations of the Medical Device actors (manufacturer, authorised representative, importer and distributor) in Europe
Principles and techniques to perform a regulatory watch, focus on the steps of the process and the means of automation
Quality manual template for medical device manufacturers, according to ISO 13485 and Regulation (EU) 2017/745
Review of Amendment A11 to EN ISO 13485:2016, containing Annexes ZA and ZB for regulations 2017/745 and 2017/746.
Definition of Medical Device (MD) in the context of the Regulation (EU) 2017/745.
Overview of the XP S99-223 standard
Summary of IEC 60601-1: General requirements for the basic safety and essential performance of medical electrical equipment.
