regulatory experts in IVD

Consulting

CE Marking | Quality Systems | Risk Management

E-Labeling / eIFU

Improve your efficiency and save more than you would think

Consulting

CE Marking | Quality Systems | Risk Management

E-Labeling / eIFU

Improve your efficiency and save more than you would think

 

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News & Events

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

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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

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