In order to ensure that patients, consumers and healthcare professionals can reap the benefits of safe, effective and innovative medical devices, the European Commission has proposed two new Regulations. The first proposal is for Regulation on medical devices and is to replace Directive 90/385/EEC...
Publication by the UK MHRA of new rules forregulating medical devices from 1 January 2021in Great Britain and Northern Ireland. August 2020: Publication ofCommission Implementing Regulation (EU) 2020/1207, containing the common specifications for the reprocessing of single-use devices. ...
What is MDR (Medical Device Regulation)? MDR Eudamed Regulatory Framework Market surveillance and vigilance European MDR and IVDR Regulations European Commission MDR Updates ARTICLES EUDAMED and the MDR extension Add my device data to EUDAMED EUDAMED Device Module is Live Add my device data to EUDAMED...
EMA has worked closely with the European Commission, the national competent authorities, notified bodies and with stakeholders from the pharmaceutical and medical device industries, to ensure a smooth transition to the new regulatory framework. To support the implementation of the MDR, updated guidance ...
The European Commission has published a factsheet addressed to competent authorities of third countries. This factsheet is one of several guidance documents published by the European Commission to clarify points and answer questions regarding the implications of the Medical Device Regulation (MDR) and ...
2023/C 163/06Commission Guidance on the content and structure of the summary of the clinical investigation report. MDCG 2021-28Substantial modification of clinical investigation under Medical Device Regulation. MDCG 2021-20Instructions for generating CIV-ID for MDR Clinical Investigations. ...
A survey from the European Commission shows that many medical device and in vitro diagnostic (IVD) manufacturers have yet to apply for certification under the Medical Devices Regulation (MDR) or In Vitro Diagnostic Medical Devices Regulation (IVDR).
On 14 December 2021, the European Commission adopted Implementing Regulation (EU) 2021/2226 laying down the rules for the provision of electronic instructions for use for devices covered by Regulation (EU) 2017/745 (the "Medical Devices Regulation"- “MDR”). This Regulation repeals the former ...
On 14 October 2021, The European Commission proposed to amend the transition period of devices covered by the In Vitro Diagnostic Regulation (IVDR) 2017/746.
Medical Devices Medical Device Coordination Group Document MDCG 2021-12 FAQ on the European Medical Device Nomenclature (EMDN) Version 1.1 1. What is the European Medical Device Nomenclature (EMDN)? Per Article 26 of Regulation (EU) 2017/745 on medical devices (MDR) and Article 23 of ...