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
MDCG Guidance Published – Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 MDCG Guidance Published – Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746... MDCG Guidance Published – Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746
26th Notified Body has been designated under the EU MDR Germany-based notified body ‘TÜV NORD CERT GmbH’ has been notified as the 26th Notified Body under the EU MDR The... 26th Notified Body has been designated under the EU MDR
MHRA – Medical Devices Guidance Update – UKRP MHRA – Medical Devices Guidance Update – UKRP The MHRA guidance on registering medical devices to place on the market... MHRA – Medical Devices Guidance Update – UKRP
