28th Notified Body has been designated under the EU MDR Slovenia-based notified body ‘SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY – SIQ’ has been notified as the 28th Notified Body under... 28th Notified Body has been designated under the EU MDR
MHRA Board Meeting – 19 April 2022 MHRA (Medicines and Healthcare products Regulatory Agency) Board Meeting – 19 April 2022 The MHRA Board will meet in public... MHRA Board Meeting – 19 April 2022
MDCG Guidance on Safety and Clinical Performance – Revised Version Published MDCG Guidance on Safety and Clinical Performance – Revised Version Published The Regulation (EU) 2017/745 on medical devices requires manufacturers to... MDCG Guidance on Safety and Clinical Performance – Revised Version Published
EU MDR Implementation – Designation of Notified Bodies EU MDR Implementation – Designation of Notified Bodies The European Commission has published an overview of the applications for designation... EU MDR Implementation – Designation of Notified Bodies
Plastic Packaging Tax – Updates Plastic Packaging Tax – Updates In preparation for the new Plastic Packaging Tax (PPT), which will take effect from 1... Plastic Packaging Tax – Updates
One Substance One Assessment – European Commission Consultation One Substance One Assessment – European Commission Consultation The European Commission has launched a call for evidence... One Substance One Assessment – European Commission Consultation
Switzerland Economic Operators – Swiss Single Registration Number Switzerland Economic Operators – Swiss Single Registration Number Swissmedic, the Swiss Agency for Therapeutic Products, has published an update regarding... Switzerland Economic Operators – Swiss Single Registration Number
EMA Reinforced Role for Emergency Situations EMA Reinforced Role for Emergency Situations The Regulation (EU) 2022/123 of the European Parliament and of the... EMA Reinforced Role for Emergency Situations
Commission Publishes Updated List of 2022 MDCG meetings Commission Publishes Updated List of 2022 MDCG meetings The European Commission has updated the list of planned MDCG and subgroup... Commission Publishes Updated List of 2022 MDCG meetings
HMA 106th Meeting Highlights – November 2021 HMA 106th Meeting Highlights – November 2021 The Heads of Medicines Agencies (HMA) has published the highlights from their 106th... HMA 106th Meeting Highlights – November 2021
MHRA – Common Registration Errors MHRA – Common Registration Errors The MHRA has shared a list of common errors/issues identified by the Registrations team, which... MHRA – Common Registration Errors
MDCG Guidance Published – Appropriate Surveillance Regarding the Transitional Provisions Under Article 120 of the EU MDR MDCG Guidance Published – Appropriate Surveillance Regarding the Transitional Provisions Under Article 120 of the EU MDR The Medical Device Coordination... MDCG Guidance Published – Appropriate Surveillance Regarding the Transitional Provisions Under Article 120 of the EU MDR
