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On January 13th, 2023, the European Commission (EC) published an overview of the coverage of the designation codes by MDR and IVDR for Notified Bodies (NB). It shows us that currently for IVDs under the IVDR over 80% of the codes are covered by 7 out of 8 NBs. An
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
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
On December 15th, 2022, a 2nd version of the EU manual on Borderline and Classification for medical devices under the MDR and IVDR has been released which introduces (only) 2 new cases. New manual on borderline and Classification in the Community Regulatory Framework for Medical Devices – version 2 Medical
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
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
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
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
