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MDCG

New MDCG Guidance documents released (January 2023 Update 2)

On January 10th, 2023, the Medical Device Coordination Group (MDCG) released a new guidance on the  health institution exemption under Article 5(5) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746. This guidance is very important for healthcare professionals and researchers of health institutions aiming to design, manufacture, modify and use

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MDR Transitional Regime

New EC proposal to amend MDR transitional regime

On January 6th, 2023, the European Commission (EC) adopted a proposal to give more time to certify medical devices to mitigate the risk of shortages. The proposal introduces a longer transition period to adapt to new rules, as foreseen under the MDR (Medical Devices Regulation). The new deadlines depend on the

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MDCG Guidance Documents

New MDCG Guidance documents released (January 2023)

On December 16th, 2022, the Medical Device Coordination Group (MDCG) released a new guidance on the Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745. The PSUR has been introduced in Article 86 of the Medical Device Regulation (MDR) 2017/745. The introduction of the PSUR requirement under the MDR

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New MDCG Guidance documents released (December 2022)

On December 6th, 2022, the Medical Device Coordination Group (MDCG) released a new guidance document. This document provides a definition for hybrid audits and clarifications with respect to how hybrid audits can be used under MDR and IVDR as advised following the publication of MDCG 2022-14 (MDCG 2022-17). MDCG 2022-17

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MDR

New MDR implementing regulations adopted!

The European Commission adopted Implementing Regulation (EU) 2022/2346 of 1 December 2022 laying down common specifications in accordance with Medical Device Regulation (MDR) (EU) 2017/745 (CS for the groups of products without an intended medical purpose listed in Annex XVI MDR) and Implementing Regulation (EU) 2022/2347 of 1 December 2022

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EURL

Updated information pack for candidate EU Reference Laboratories published

On November 30th, 2022, the European Commission has published an information pack for candidate laboratories in the context of European Union Reference Laboratories (EURLs) in the field of in vitro diagnostic medical devices. European Union Reference Laboratories in the field of in vitro diagnostic medical devices – information pack for

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