EMA establishes regular scientific advice on certain high-risk medical devices
The European Medicines Agency (EMA) and the EU Commission have established a standard procedure for manufacturers of certain high-risk medical…
Medical devices: EU Commission assesses public procurement issues in China
An EU Commission report, published today, highlights a continued discrimination against EU medical devices in China's public procurement market. The EU Commission assesses, how…
Medical devices and EUDAMED: EU Council adopts measures to prevent shortages
The EU Council has adopted new rules updating the law on medical devices in order to help prevent shortages and ease the…
Ethical and legal aspects of microchip implants in brains – EU Commission
Implantable medical devices fall into the scope of Regulation (EU) 2017/745 on medical devices[1] (MDR) and must comply with its general…
Medical devices: EU Council endorses new measures to help prevent shortages
Around two thirds of all clinical decisions are based on information provided by IVDs, which include tests for HIV, cancer,…
Antitrust: EU Commission carries out unannounced inspections in the medical devices sector
The European Commission is carrying out unannounced inspections at the premises of a company active in medical devices for cardiovascular…
EU Commissioner Kyriakides welcomes EU Council vote on the Medical Device Regulation extension
Brussels, 7 March 2023 Today, the Council of the European Union has adopted the Commission’s...
Public health: EU Commission adopts proposal for more time to certify medical devices
Brussels, 6 January 2023 Today, the Commission adopted a proposal to give more time to...
In-Vitro Diagnostic Medical Devices: EU Commission proposes progressive roll-out of new regulation
Brussels, 14 October 2021 Today, the European Commission has proposed a progressive roll-out of the...
Medical Devices Regulation: EU Commission Q&A on EU safety rules
Brussels, 26 May 2021, 1. Why do we need new rules on medical devices? The...
Public health: Stronger rules on medical devices
Brussels, 26 May 2021 As of today, new EU rules on medical devices (MDR) enter...
EU Commission publishes notice on EU-Switzerland Mutual Recognition Agreement for Medical Devices
Brussels, 26 May 2021 Today, the Commission has published a notice to stakeholders informing them that the mutual recognition...
DRAFT OPINION on the proposal for a regulation of the European Parliament and of the Council on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices – PE689.565v01-00
DRAFT OPINION on the proposal for a regulation of the European Parliament and of the...