EU Commission Release List of Notified Bodies with their Published Fees
In a significant move to promote transparency and fairness in the medical device market, the European Commission has released a comprehensive list of notified bodies along with their published fees for conformity assessments. This initiative is expected to bring much-needed clarity to the certification process, ensuring that manufacturers, particularly small and medium-sized enterprises (SMEs), can ...
Regulation (EU) 2024/1860 Published in Official Journal of the European Union (OJEU)
The proposal put forward by the EU Commission regarding the extension in transitional provisions of certain in-vitro diagnostic medical devices, gradual roll-out of EUDAMED and the obligation to inform in case of interruption or discontinuation of supply has been officially published in the Official Journal of the EU. The published regulation can be accessed using ...
Q&A on the Extension of the IVDR Transitional Periods has been Released
The EU Commission has released an informative Q&A document intended to provide guidance on the implementation of the extended transitional period provided for in the IVDR, as amended by Regulation (EU) 2024/1860 of 13 June 2024 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of EUDAMED, the obligation to inform in ...
Gradual Rollout of EUDAMED Roadmap Published
The EU Commission has published a roadmap to illustrate the current planning for the gradual roll-out of EUDAMED. This roadmap is intended to give the relevant actors estimated timeframes of when each module will become mandatory for use. According to the roadmap published, the notice for the Actor, UDI/Devices, NB & Certificates and Market Surveillance ...
EU Parliament Adopts the Proposal Put Forward by the EU Commission Regarding the Extension in the Transition Periods for Certain IVD’s
The EU Commission has welcomed the adoption by the EU Parliament for the proposal that has been put forward regarding the extension in the transition periods for certain IVDR’s. The new rules will give more time for manufacturers to transition to the new requirements of the IVDR and aims to mitigate the risk of device ...
Two Commission Implementing Decisions with References of Harmonised Standards Have Been Published.
On March 8th 2024 the EU Commission published in the Official Journal of the European Union (OJEU) two Commission implementing decisions concerning new references of harmonised standards in support of Regulation (EU) 2017/745 on medical devices (MDR) and of Regulation (EU) 2017/746 (IVDR). For the MDR: Commission Implementing Decision (EU) 2024/815 of 6 March 2024, ...
MDCG 2024-2: Procedures for the updates of the European Medical Device Nomenclature
The MDCG has released a guidance document concerning EMDN codes. This document is split into three main sections and provides an overview of the actors involved in the generation and maintenance of the EMDN codes and lays out the procedures for the annual revision of the EMDN Codes as well as the procedure for ad-hoc ...
EU Commission Proposes IVDR Extension
The introduction of the IVDR came with very substantial regulatory changes to the regulatory framework for IVD’s. One of the most significant changes is the increased involvement of independent notified bodies for the conformity assessment that is proportionate to the classification of the device. Under the IVDD, only a small number of high-risk devices equating ...
The European Commission’s Directorate-General for Health and Food Safety has published MDR and IVDR Language Requirements for Manufacturers.
The EU is made up from 27 countries, most of them having their own national language. Since there is no official language of the European Union, each member state has different requirements that would need to be respected when making a device available in a particular member state. The MDR and IVDR both contain legal ...
The First IVDR Reference Labs Have Been Designated
On December 5th, 2023, the EU Commission adopted implementing regulation (EU) 2023/2713 designating 5 European Union reference laboratories in the field of in vitro diagnostic medical devices. These 5 European Union reference laboratories will be involved in the conformity assessment of Class D in vitro diagnostic devices and other advisory tasks. The important tasks these ...
