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
PAGB Introduction to CBD Workshop The next PAGB Introduction to CBD workshop will be held via Microsoft Teams on Wednesday 5 June from 10am – 1pm. PAGB Introduction to CBD Workshop
MHRA Board Members and Committee Lists Updated The MHRA has updated the board members and committee list on their website. MHRA Board Members and Committee Lists Updated
MDCG Guidance – Appropriate Surveillance Regarding the Transitional Provisions Under Article 120 – 2nd Revision The second revision of the MDCG 2022-4: Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the EU MDR with regard to devices covered by certificates according to the MDD or the AIMDD has been published. MDCG Guidance – Appropriate Surveillance Regarding the Transitional Provisions Under Article 120 – 2nd Revision
EMA Q&A Document on Article 117 – 4th Revised Version Published EMA has published the fourth revised version of its questions & answers document on Article 117 MDR (practical considerations concerning combination products). EMA Q&A Document on Article 117 – 4th Revised Version Published
MHRA – International Recognition of Medical Devices MHRA has published a statement of policy intent for recognition by the UK of approvals of medical devices from international regulators. MHRA – International Recognition of Medical Devices
Smarter Regulation Update DBT has published two policy papers "Smarter Regulation: Delivering a regulatory environment for innovation, investment and growth" and "Smarter Regulation: One Year On – May 2024". Smarter Regulation Update
