Pursuant to Regulation (EU) 2024/1860, the arrangements for the transfer of the surveillance from the notified body that issued the certificate to the notified body designated in accordance shall be clearly defined in an agreement between the manufacturer and the notified body designated and where practicable, the notified body that issued the certificate. In attempts … Read more
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
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 … Read more
Persuant to question 5 of the Q&A released by the EU Commission, manufacturers need to demonstarte that the conditions for the extension are fulfilled by means of a self-declaration, similar to the form produced for the MDR extension. The self-declaration should also state the end date of the transition peroid and should clearly identify the … Read more
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 … Read more
There has been an update in the guidance document MDCG 2020-16 concerning the classification rules for in vitro diagnostic medical devices under regulation (EU) 2017/746. During this third revision, one can note there have been a few updates to this document. The most significant update is in the definitions section where there has been the … Read more
As expected, the EU 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 information. These new regulations aim to prevent shortages by encompassing the following: The regulation that has adopted will enter into force following publication in … Read more
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 … Read more
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 … Read more
In order to address the slow transition and prevent shortages of IVDs on the market, the amending regulation (EU) 2022/112 of 25 January 2022 introduced a stepped extension of transition periods based on the classification of the IVD. While the amending regulation has provided additional transitional time, the first deadline of 26 May 2025 for … Read more
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