Switzerland – Swissmedic prepares medtech industry for activation of medical devices database module
The first module of the swissdamed medical devices database goes online in August
Since the MRA with the EU has not been updated, Swissmedic does...
Europe – Health Technology Assessment : Guidance on reporting requirements for multiplicity issues and...
This guidance describes how to deal in practice with multiplicity issues and
complementary analyses (like specific subgroup analyses, specific post hoc analyses and sensitivity analyses)...
Europe – Health Technology Assessment : Guidance on outcomes for joint clinical assessments
Clinical outcome assessments (COAs), used in clinical studies (whether they are interventional (also called experimental), or observational), are a key component of health technology...
Europe – Phthalates in certain medical devices: updated SCHEER guidelines published
Today, following a request from the European Commission, the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) provided the update of their guidelines on...
Europe – Update – MDCG 2022-13 Rev.1 – Designation, re-assessment and notification of conformity...
This document aims to provide guidance to the authorities responsible for notified
bodies (hereafter, the Designating Authorities) and joint assessment teams (JATs)
when conducting:
− assessments of...
Europe – MDCG 2024-1-5 : Guidance on the vigilance system for CE-marked devices DSVG...
The aim of this Device Specific Vigilance Guidance (DSVG) is to harmonise vigilance
reporting and provide guidance for manufacturers of Urogynaecological Surgical
Mesh Implants used for...
Europe – Monitoring the Availability of Medical Devices and In Vitro Diagnostic Medical Devices...
Medical devices (MDs) and in vitro diagnostic medical devices (IVDs) are essential for a working healthcare system and play a crucial role in the...
Europe – Annual report 2023
The Management Board’s oversight role covers the full range of EMA programmes and activities, making sure that the Agency works effectively and co-operates successfully...
Europe – Medical devices: Council adopts new measures to help prevent shortages
The Council has adopted new rules updating the law on medical devices in order to help prevent shortages and ease the transition to greater transparency and access to...
Europe – Questions & Answers for applicants, marketing authorisation holders of medicinal products and...
This Question and Answer (Q&A) document provides practical considerations concerning the implementation of the medical devices and the in vitro diagnostic medical devices regulations...
