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
Regulation (EU) 2017/745
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.
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
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.