Manual on Borderline and Classification in the Regulatory Framework for Medical Devices (MDR 2017/745)
Analysis of borderline devices: medical device status and class under Regulation (EU) 2017/745
The Medical Device Blog
Expert panel opinions on clinical evaluations: procedure and synthesis of consultations
Opinions of expert groups in the clinical evaluation of medical devices
Impact of the European regulation on medical devices, seen from Switzerland
Swiss Medtech sector study 2022, impact of the 2017/745 regulation
Notified Bodies: list of standard fees (MDR certification)
Comparison of Notified Body fees in the context of the european regulation on medical devices
Commission Recommendation on the definition of nanomaterial
Definitions of nanomaterial, particle, aggregate, and agglomerate.
Understanding the Standards’ references
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 definition, types, evaluation and risk management
Risks: definitions, major types and management methods. General guide, applicable to all risks (health, climate, professional, etc.)
The 7 principles of quality management
This article presents the “philosophy” of the 7 principles of quality management. Each principle is illustrated with a quote, for ease of understanding.
HLS: High Level Structure for management system standards
This article proposes to summarize the High Level Structure for management system standards
5S method
The 5S method was formalized in the industrial workshops of Toyota, to allow improving the organization of a workspace.
Production Process validation: Cp, Cpk, standard deviation… statistical methods
Principles and calculations for process validation: capability coefficients, standard deviation, centering, error, number of samples required, etc.
PMCF: Post-Market Clinical Follow-up for Medical Devices, Guidance
Summary of PMCF requirements: Post-Market Clinical Follow-up of medical devices, according to Regulation 2017/745 (definition, methods, expected documents…)
Regulation (EU) 2017/745: guidance for Medical Devices manufacturers
Guidance on the implementation of Regulation (EU) 2017/745 on medical devices, particularly for manufacturers.
PSUR: Periodic Safety Update Report for Medical Devices
Presentation of the Periodic Safety Update Report for medical devices (PSUR) required by the Medical Device Regulation (UE) 2017/745
Cybersecurity for Medical Devices
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
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.
IEC 62366-1 – Medical Devices – Usability Engineering : a Summary
Summary of the standard IEC 62366-1 Medical devices Usability engineering: examples and methods.
Clinical evaluation of Medical Devices
Introduction to the clinical evaluation of medical devices and corresponding regulatory requirement to obtain and maintain the CE marking
Post-marketing surveillance (PMS) for medical devices
Post-marketing surveillance process and phases
[summary] XP S99-223 – Medical Devices – Benefit/risk management
Summary of the XP S99-223 standard on the management of the benefit/risk ratio of medical devices for regulatory purposes
Roles and obligations in the Medical Devices Regulation
Roles and obligations of the Medical Device actors (manufacturer, authorised representative, importer and distributor) in Europe
Doing a Regulatory Watch for medical devices
Principles and techniques to perform a regulatory watch, focus on the steps of the process and the means of automation
Quality manual, ISO 13485 and MDR, free template
Quality manual template for medical device manufacturers, according to ISO 13485 and Regulation (EU) 2017/745
EN ISO 13485/A11: Annex ZA and ZB for regulations 2017/745 and 2017/746
Review of Amendment A11 to EN ISO 13485:2016, containing Annexes ZA and ZB for regulations 2017/745 and 2017/746.
European Definition of “Medical Device”
Definition of Medical Device (MD) in the context of the Regulation (EU) 2017/745.
XP S99-223:2020 – Medical devices – Benefit/risk management – overview
Overview of the XP S99-223 standard