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Common specifications

Common Specifications adopted!

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

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Blue Guide

Blue Guide 2022 published!

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

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EURL Implementing Regulations

EURL Implementing Regulations released!

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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Companion diagnostics

EMA Guidance Companion Diagnostics!

On June 17th, 2022, the European Medicines Agency (EMA) released its guidance on procedural aspects to facilitate the consultation procedure to the EMA by notified bodies on companion diagnostics, as per Article 48(3), (4), (7) and (8) of the IVDR. This guidance document is intended to provide the relevant parties, in

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MDCG guidelines

New MDCG Guidance documents released (June 2022)

On May 25th and June 13th, 2022, the Medical Device Coordination Group (MDCG) released two new guidance documents. A Q&A on the interface between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (CTR) and Regulation (EU) 2017/746 (MDCG 2022-10) and a position paper, which is a

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New MDCG Guidance documents released

On May 20th, 2022, the Medical Device Coordination Group (MDCG) released three new guidance documents. A Q&A on the Unique Device Identification system under MDR and IVDR (MDCG 2022-7), a guidance regarding the application of IVDR requirements to “legacy devices” and to devices placed on the market prior to 26

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New MDR and IVDR harmonised standards published

May 11th, 2022, “Commission Implementing Decision (EU) 2022/757 of 11 May 2022 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for quality management systems, sterilisation and application of risk management to medical devices” and “Commission Implementing Decision (EU) 2022/729 of 11 May 2022 amending Implementing Decision (EU) 2021/1195 as

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Swiss Third Country Status for IVDs

The Mutual Recognition Agreement (MRA) between Switzerland end the European Union was not renewed to include the IVD Regulation 2017/746. Thus, as of the Date of Application (DoA) of the IVDR, 26 May 2022, Switzerland will be considered a third country under the IVDR for both IVDR compliant devices as

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Qarad IVDR Conference 2022

NHOW Brussels

October 11-13

Get the latest IVDR insights during our three-day conference, including a pre-conference workshop.