MDCG Standards Working Group – 13 June 2024 The European Commission has published the official minutes from the MDCG Standards Working Group that took place on 13 June 2024. MDCG Standards Working Group – 13 June 2024
Information Session on EU MDR/IVDR for International Regulators On 4 July 2024 the European Commission hosted an information session on EU MDR/IVDR for international regulators, the slides and recording from this event have been published. Information Session on EU MDR/IVDR for International Regulators
EMA-AESGP Bilateral – April 2024 – Highlights Published The European Medicines Agency (EMA) has published the highlights from the fifth EMA-AESGP bilateral meeting held on 29 April 2024. EMA-AESGP Bilateral – April 2024 – Highlights Published
Team NB Position Paper – Transfer Agreement for Surveillance of Legacy Devices – Version 2 Team NB has published an updated version of its position paper on the transfer agreement for surveillance of legacy devices. Team NB Position Paper – Transfer Agreement for Surveillance of Legacy Devices – Version 2
Commission MDR/IVDR Virtual Information Session The European Commission will host a virtual information session to present the current status of the targeted evaluation of MDR/IVDR on Thursday, 12 September 2024. Commission MDR/IVDR Virtual Information Session
MDCG 2021-5 Rev.1 – July 2024 Guidance on Standardisation for Medical Devices The Medical Device Coordination Group (MDCG) has endorsed the newly revised version of MDCG 2021-5 Guidance on standardisation for medical devices. MDCG 2021-5 Rev.1 – July 2024 Guidance on Standardisation for Medical Devices
Commission Publishes Updated List of 2024 MDCG Meetings The Commission has published an updated version of planned meeting dates of the MDCG and subgroups for 2024. Commission Publishes Updated List of 2024 MDCG Meetings
TOPRA Symposium TOPRA is hosting their annual Symposium in Rotterdam, at the Postillion Hotel WTC, between 30 September and 2 October 2024. TOPRA Symposium
SCHEER Guidelines on Benefit-risk Assessment of Phthalates in Certain Medical Devices The European Commission and its Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) have published an update of the SCHEER guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates, which are carcinogenic, mutagenic, toxic to reproduction or have endocrine-disrupting properties. SCHEER Guidelines on Benefit-risk Assessment of Phthalates in Certain Medical Devices
MDCG-2022-13: Designation, Re-assessment and Notification of Conformity Assessment Bodies and Notified Bodies The revised version of 2022-13 MDCG Guidance on Designation, re-assessment and notification of conformity assessment bodies and notified bodies has been published on the Commission website. MDCG-2022-13: Designation, Re-assessment and Notification of Conformity Assessment Bodies and Notified Bodies
EMA Variation Guideline Revision – Stakeholder Consultation The European Medicines Agency (EMA) has launched a stakeholder consultation on the revised European Commission guidelines on variations categories and procedures. EMA Variation Guideline Revision – Stakeholder Consultation
PAGB Food Supplements Regulatory Workshop The next PAGB Food Supplements Regulatory workshop will be held via Microsoft Teams on Thursday 4 July from 10am – 4pm. PAGB Food Supplements Regulatory Workshop
