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On May 24th, 2023, the European Commission released a new template for Notified Bodies. This form is to be used as confirmation letter on the status of a formal application, written agreement, and appropriate surveillance in the framework of Regulation (EU) 2023/607 amending Regulation (EU) 2017/745 (MDR) and Regulation (EU)
On May 12th, 2023, the Medical Device Coordination Group (MDCG) released the first revision on the guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD. (MDCG 2020-03 Revision 1). MDCG 2020-03 Rev. 1
On May 12th, 2023, the European Commission released a guidance, in accordance with Article 77(6) of Regulation (EU) 2017/745 on medical devices (MDR), for the content and structure of the summary of the clinical investigation report. This guidance aims to ensure that the summary of the clinical investigation report presents
On April 27th, 2023, the UK Government published a draft amendment to the UK Medical Device Regulations 2002 which is the first statutory instrument released in the process towards a new regulatory framework. This future regulatory framework will introduce a substantial reform of the current legislation for medical devices (The
Last month, Medtech released the 3rd revision of the clinical evidence requirements under the EU In Vitro Diagnostic Medical Device Regulation 2017/746 (IVDR). This guidance document from Medtech is a collection of questions and answers designed to help manufacturers navigate their performance evaluation obligations under the new IVDR. Medtech – Clinical evidence requirements
On February 14th, 2023, the Medical Device Coordination Group (MDCG) released a Q&A on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices (MDCG 2023-03). MDCG 2023-03 Q&A on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices. This document
On March 1st, 2023, Team NB released a new position paper on best practice guidance for the submission of technical documentation under Annex II and Annex III of the European (EU) In Vitro Diagnostic Regulation 2017/746 (IVDR). This best practice guidance document has been developed by members of Team NB
On January 6th, 2023, the European Commission (EC) adopted a proposal to extend the already existing transitional period for legacy devices under the MDR. The goal of this extension is to maintain patients’ access to a wide range of medical devices while ensuring the transition to the new framework under
