Regulatory news

Subscribe to Qarad’s newsflash and receive important regulatory updates immediately in your mailbox

New EMA FAQ on medicinal products development and assessment involving a CDx

On December 6th, 2023, EMA released a Questions and Answers (Q&As) document that aims to provide an overview of the Agency’s current line of thinking on specific issues related to predictive biomarker-guided medicinal products development and assessment including a companion diagnostic (CDx) development. This Q&As document does not address assessment

Read More

New MDCG Guidance documents released

On December 21st, 2023, the Medical Device Coordination Group (MDCG) released the first revision on the questions and answers on Articles 13 & 14 on the requirements of importers and distributors of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 (MDCG 2021-27 Revision 1). MDCG 2021-27 Rev. 1: Questions & Answers

Read More

New MDCG Guidance documents released

On December 14th, 2023, the Medical Device Coordination Group (MDCG) released 2 new guidance documents for products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 on medical devices (MDR). A guidance on qualification and classification of Annex XVI products (MDCG 2023-05) and a guidance on

Read More

New MDCG Guidance documents released

On December 12th, 2023, the Medical Device Coordination Group (MDCG) released the first revision on the Q&A regarding clinical investigations of devices conducted within the scope of the Regulation (EU) 2017/745 (MDR) (MDCG 2021-06 Revision 1). MDCG 2021-06 Rev. 1: Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation

Read More

New MDCG Guidance documents released

On November 29th, 2023, the Medical Device Coordination Group (MDCG) released the first revision on the position paper on the notice to manufacturers and notified bodies to ensure timely compliance with MDR and IVDR requirements. (MDCG 2022-11 Revision 1). This position paper calls for the continued full commitment of all

Read More