Regulatory news

On January 23rd, 2024, the European Commission published a proposal to amend Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) and Regulation (EU) 2017/745 on medical devices (MDR) introducing a gradual roll-out of Eudamed, the obligation of manufacturers to inform authorities and downstream economic operators in case of

On January 17th, 2024, the European Commission EU Health and Food Safety (DG Sante) has published an overview of the language requirements for manufacturers of medical devices. The Commission and Member States have created specific tables for MDR and IVDR. IVDR – National language requirements for manufacturers (January 2024) MDR

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

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

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

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

On 5 December 2023, the European Commission adopted an implementing act designating 5 EU reference laboratories (EURLs) in the field of in vitro diagnostic medical devices (IVDs). These EURLs will be involved in conformity assessment of high-risk (class D) IVDs as well as carry out certain advisory tasks.  Commission Implementing Regulation (EU)

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