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On September 7th, 2022, a first version of the EU manual on Borderline and Classification for medical devices under the MDR and IVDR has been released. Additional cases will be populated when their review is completed under the so-called ‘Helsinki Procedure’ involving national competent authorities and the MDCG New manual
On August 10th, 2022, the Medical Device Coordination Group (MDCG) released a new guidance document. This document aims to provide guidance to the authorities responsible for notified bodies and joint assessment teams (JATs) when conducting a) assessments of conformity assessment bodies (CABs) that apply for designation of notified bodies (NB)
On July 13th 2022, the Medical Device Coordination Group (MDCG) released a new guidance document. This latest release provides guidance to Member States and other relevant parties on the application of certain IVDR provisions during the absence of Eudamed. To that end, this guidance intends to describe harmonised administrative practices
Between September and November 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) consulted on proposed changes to the regulatory framework for medical devices in the United Kingdom (UK). On June 26th 2022, the outcome of this consultation was published. This document describes the transitional arrangements for in vitro diagnostic
In July 2022, the European Commission sent a call for EU reference laboratories under Regulation (EU) 2017/746 to the EU Member States, as well as Iceland, Norway, Liechtenstein and Turkey. The deadline for Member States to submit nominations to the Commission is 31 March 2023. Interested candidate laboratories should contact their
On July 4th, 2022, the European Commission adopted “Commission Implementing Regulation (EU) 2022/1107 of 4 July 2022 laying down common specifications for certain class D in vitro diagnostic medical devices in accordance with Regulation (EU) 2017/746 of the European Parliament and of the Council”. This implementing regulation lays down common specifications
On June 29th, 2022, the European Commission published an updated version of the Blue Guide on the implementation of EU product rules. The Blue Guide is a non-binding instrument first published in 2000. It has been subsequently updated twice, in 2014 and 2016. The 2022 revision is a substantial update and
On June 17th, 2022, the European Commission adopted two implementing regulations that outline the tasks of and criteria for European Union reference laboratories in the field of in vitro diagnostic medical devices (Commission Implementing Regulation (EU) 2022/944) as well as the fees that may be levied by EU reference laboratories
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