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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

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New Study supporting the monitoring of availability of medical devices on the EU market – Surveys for MD and IVD manufacturers and authorised representatives

The European Commission’s Directorate-General for Health and Food Safety (DG SANTE) – via its European Health and Digital Executive Agency (HaDEA) – commissioned a “Study supporting the monitoring of the availability of medical devices on the EU market”. New Study supporting the monitoring of availability of medical devices on the

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New MDCG released!

On September 26th, 2023, the Medical Device Coordination Group (MDCG) released a Q&A on the transitional provisions for products without an intended medical purpose covered by Annex XVI of the MDR. The newly published Q&A document intends to facilitate the application of the transitional provisions set out in Commission Implementing

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MDCG

New MDCG released

On June 30th, 2023, the Medical Device Coordination Group (MDCG) released Addendum 1 to the position paper MDCG 2022-18 on the application of Article 97 of Regulation (EU) 2017/745 on medical devices (MDR) to legacy devices for which the 93/42/EEC (MDD) or Directive 90/385/EEC (AIMDD) has expired or expires before

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