MHRA Guidance Published – Risk-Adapted Approach to Clinical Trials and Risk Assessments MHRA Guidance Published – Risk-Adapted Approach to Clinical Trials and Risk Assessments The MHRA has published guidance on Risk-Adapted Approach... MHRA Guidance Published – Risk-Adapted Approach to Clinical Trials and Risk Assessments
MHRA Guidance Published – Oversight and Monitoring of Investigational Medical Product Trials MHRA Guidance Published – Oversight and Monitoring of Investigational Medical Product Trials The MHRA has published oversight and monitoring of... MHRA Guidance Published – Oversight and Monitoring of Investigational Medical Product Trials
EU Commission – Public Consultation on REACH Regulation Revision EU Commission – Public Consultation on REACH Regulation Revision The European Commission has launched a public consultation... EU Commission – Public Consultation on REACH Regulation Revision
EU Commission Website on Medical Devices from DG SANTE Revamped EU Commission Website on Medical Devices from DG SANTE Revamped The EU Commission’s websites from DG SANTE on medical devices... EU Commission Website on Medical Devices from DG SANTE Revamped
EU Commission Updates the Rolling Plan Containing List of Essential Implementing Acts for the MDR European Commission Updates Rolling Plan The European Commission has updated the Rolling Plan (as of January 2022)... EU Commission Updates the Rolling Plan Containing List of Essential Implementing Acts for the MDR
DEFRA Consultation Outcome – Restriction of Phthalates Medical Devices, Monitoring and Control Instruments DEFRA Consultation Outcome – Restriction of Phthalates Medical Devices, Monitoring and Control Instruments On 14 September 2021 the Department for... DEFRA Consultation Outcome – Restriction of Phthalates Medical Devices, Monitoring and Control Instruments
Obligations of Economic Operators Regarding Medical Devices Under Swiss Legislation – Updated Information Sheet Obligations of Economic Operators Regarding Medical Devices Under Swiss Legislation – Updated Information Sheet The Swiss Agency for Therapeutic Products... Obligations of Economic Operators Regarding Medical Devices Under Swiss Legislation – Updated Information Sheet
EMA Public Consultation on ‘Guidance on the procedural aspects for the consultation to the European Medicines Agency by a notified body on companion diagnostics’ and EMA Guidance on Companion Diagnostics Consultation Procedure Published EMA Public Consultation on ‘Guidance on the procedural aspects for the consultation to the European Medicines Agency by a notified... EMA Public Consultation on ‘Guidance on the procedural aspects for the consultation to the European Medicines Agency by a notified body on companion diagnostics’ and EMA Guidance on Companion Diagnostics Consultation Procedure Published
27th Notified Body has been designated under the EU MDR Italy-based notified body ‘ITALCERT SRL’ has been notified as the 27th Notified Body under the EU MDR The designation of... 27th Notified Body has been designated under the EU MDR
EUDAMED – Commission Website Dedicated to Actor Registration Module Available – Updated FAQs Published (V7) EUDAMED – Commission Website Dedicated to Actor Registration Module Available – Updated FAQs Published (V7) The Commission has updated the... EUDAMED – Commission Website Dedicated to Actor Registration Module Available – Updated FAQs Published (V7)
MHRA Business Impact Target – NQRP Summary for 2020/21 MHRA Business Impact Target – NQRP Summary for 2020/21 The business impact target (BIT) is a cross-government target for the... MHRA Business Impact Target – NQRP Summary for 2020/21
EU MDR Harmonised Standards – Implementing Decision 2022/6 Published in EU’s Official Journal EU MDR Harmonised Standards – Implementing Decision 2022/6 Published in EU’s Official Journal The Implementing Decision 2022/6 amending Implementing Decision... EU MDR Harmonised Standards – Implementing Decision 2022/6 Published in EU’s Official Journal
