New guideline from the European Medicines Agency (EMA) on the Environmental Risk Assessment of medicinal products for human use, accepted on February 15 and set to come into effect on September 1, 2024, stipulates that an ERA report will be
On April 17th, 2024, the Medical Device Coordination Group (MDCG) released a new guidance document on content of the Investigator’s Brochure for clinical investigations of medical devices under Regulation (EU) 2017/745 or the medical device regulation (MDR) (MDCG 2024-5).
On April 15th, 2024, the Medical Device Coordination Group (MDCG) released a new guidance document on safety reporting in performance studies of in vitro diagnostic medical devices (IVDs) as per Article 76(2) of Regulation (EU) 2017/746 – In Vitro Diagnostic
The Medical Device Coordination Group (MDCG) released a guidance document on the content of the Clinical Investigation Plan for clinical investigations of medical devices
The Medical Device Coordination Group (MDCG) released a procedure for the updates of the European Medical Device Nomenclature (EMDN). The EMDN, as established by Article 26 of Regulation (EU) 2017/745 – MDR and Article 23 of Regulation (EU) 2017/746 –
The Medical Device Coordination Group (MDCG) released a Device Specific Vigilance Guidance Document (DSVG) to harmonize vigilance reporting and provide guidance for manufacturers of Specific Devices.
Commission Implementing Decision (EU) 2024/815 as regards harmonised standards for “medical gloves for single use, biological evaluation of medical devices, sterilization of health care products, packaging for terminally sterilized medical devices and processing of health care products” and “Commission Implementing
The Council of the European Union officially endorsed without any changes the proposal to amend IVDR and MDR
EU Commission proposes IVDR & MDR amendments: Eudamed rollout, supply interruption reporting, extended transitional provisions for certain IVDR devices.
EU Commission published MDR and IVDR language requirement tables for medical device manufacturers, aiding compliance with linguistic regulations across Member States.
EMA released Q&A on biomarker-guided meds, excluding clinical trial approval and CDx conformity. Offers guidance for marketing authorization data generation.
MDCG revises Q&A on importers, distributors’ requirements (MDCG 2021-27 Revision 1), EU Regulations 2017/745 & 2017/746.
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