EU Parliament Vote to Revise MDR and IVDR
The EU Parliament has adopted a resolution to revise the MDR and IVDR to address the ongoing challenges regarding implementation and support patient access to essential medical devices by 2025. The EU Parliament’s proposed amendments to the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) are timely, balancing much-needed reform with a commitment ...
EU Publishes New Harmonised Standards for MDR and IVDR
To provide some context, a harmonized standard is a European standard developed by recognized European Standards Organizations such as: These standards are created based on a formal request from the European Commission. They are crucial for manufacturers, economic operators, and conformity assessment bodies, as they offer a recognized way to demonstrate compliance with relevant EU ...
MDCG 2024-11 Guidance on qualification of in vitro diagnostic medical devices
The MDCG has recently published a guidance concerning the qualification of in vitro diagnostic medical devices. The purpose of this guidance document is to clarify what products fall in scope of Regulation 2017/746 on in vitro diagnostic medical devices (IVDR) or an accessory to an IVD. For a product to qualify as an IVD or ...
Current State of Play for Medical Devices (MDR & IVDR)
We understand that the regulatory landscape of the MDR and IVDR is constantly changing, and in order to keep up to date with the changes, we have provided a current state of play with regards to some of the most important changes to the MDR and IVDR. MDR Extension Firstly, we would like to remind ...
UPDATE: MDCG 2021-4 Rev. 1 Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746
The guidance document MDCG 2021-4 has been updated. For context, under Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), manufacturers of class D in vitro diagnostic medical devices (IVDs) are required to submit their applications to a notified body as part of the conformity assessment process. Additionally, under certain conditions, specific elements of ...
New Notified Body has been Designated under the IVDR
A new notified body has been designated for the IVDR. The new notified body, ISTITUTO SUPERIORE DI SANITA’ (NB 0373), is based in Italy. This new addition brings the total number of notified bodies designated under IVDR to 13. More information on the notified body can be found using the following link
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 ...
