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
MHRA Announces Dedicated New Team to Support the International Community in Tackling Antimicrobial Resistance MHRA's specialized team to support the international community combat the growing threat of antimicrobial resistance (AMR). MHRA Announces Dedicated New Team to Support the International Community in Tackling Antimicrobial Resistance
49th Notified Body Designated Under the EU MDR Austria-based Notified Body ‘QMD Services GmbH’ has been notified as the 49th Notified Body under the MDR. 49th Notified Body Designated Under the EU MDR
MHRA – Enforcing the Medical Devices Regulations MHRA has published an updated version of ‘Medical devices: the regulations and how we enforce them’ to reflect changes to the legislation relating to MHRA’s investigatory and enforcement powers. MHRA – Enforcing the Medical Devices Regulations
BIVDA Webinar – An Introduction to the Procurement Act 2023 MHRA has published the recording of the webinar on the established medicines licensing process, which took place in April 2024. BIVDA Webinar – An Introduction to the Procurement Act 2023
Preliminary Assessment Review (PAR) and Preliminary Re-assessment Review (PRAR) Form Template for EU MDR and IVDR published Several MDCG guidance documents have been published on the Commission website (MDCG 2024-6, MDCG 2024-7, MDCG 2024-8, MDCG 2024-9). These concern the Preliminary assessment review (PAR) and Preliminary re-assessment review (PRAR) form templates for the EU MDR and IVDR. Preliminary Assessment Review (PAR) and Preliminary Re-assessment Review (PRAR) Form Template for EU MDR and IVDR published
48th Notified Body Designated Under the EU MDR Türkiye-based Notified Body ‘Kiwa Belgelendirme Hizmetleri A.Ş.’ has been notified as the 48th Notified Body under the MDR 48th Notified Body Designated Under the EU MDR
