Team NB Publishes Position Papers on Off Label Use and Cyber Security Team NB Publishes Position Papers on Off Label Use and Cyber Security Team-NB has published the following two position papers:... Team NB Publishes Position Papers on Off Label Use and Cyber Security
Team-NB Position Papers Published – Submission of TD + Transfer Agreement Team-NB Position Papers Published – Submission of TD + Transfer Agreement Team NB has published several position papers in relation... Team-NB Position Papers Published – Submission of TD + Transfer Agreement
Team NB Position Paper on Transitional Period for the Implementation of MDCG Guidance Team NB Position Paper on Transitional Period for the Implementation of MDCG Guidance Team NB has published a position paper... Team NB Position Paper on Transitional Period for the Implementation of MDCG Guidance
EMA Workshop on Patient Experience Data in Medicines Development and Regulatory Decision-making EMA Workshop on Patient Experience Data in Medicines Development and Regulatory Decision-making The European Medicines Agency (EMA) has... EMA Workshop on Patient Experience Data in Medicines Development and Regulatory Decision-making
Team NB Position Paper on Hybrid Audits Team NB Position Paper on Hybrid Audits Team NB has published a position paper on the application of hybrid audits... Team NB Position Paper on Hybrid Audits
Commission Proposal on Single Market Emergency Instrument Published Commission Proposal on Single Market Emergency Instrument Published The European Commission has tabled a legal proposal establishing... Commission Proposal on Single Market Emergency Instrument Published
33rd Notified Body has been designated under the EU MDR Poland-based Notified Body ‘POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.’ has been notified as the 33rd Notified Body under the EU... 33rd Notified Body has been designated under the EU MDR
DHSC Webinar Replay – Equity in Medical Devices: Independent Review Call for Evidence DHSC Webinar Replay – Equity in Medical Devices: Independent Review Call for Evidence DHSC held a webinar on Wednesday 7... DHSC Webinar Replay – Equity in Medical Devices: Independent Review Call for Evidence
MHRA Webinar – Changes to the Submission Routes for Reporting Medical Device Adverse Incidents MHRA Webinar – Changes to the Submission Routes for Reporting Medical Device Adverse Incidents Following the postponement of the ‘Changes... MHRA Webinar – Changes to the Submission Routes for Reporting Medical Device Adverse Incidents
EU IVDR Implementation – Final MDCG Guidance on Appropriate Surveillance Regarding the Transitional Provisions under Article 110(3) Published EU IVDR Implementation – Final MDCG Guidance on Appropriate Surveillance Regarding the Transitional Provisions under Article 110(3) Published The European... EU IVDR Implementation – Final MDCG Guidance on Appropriate Surveillance Regarding the Transitional Provisions under Article 110(3) Published
MHRA Updates Software Applications (Apps) Guidance MHRA updates its guidance on software applications (apps) MHRA has updated its guidance on when software applications are considered to... MHRA Updates Software Applications (Apps) Guidance
EU IVDR Implementation – MDCG Guidance Providing Clarification on First Certification of Type of Device Revised Version Published EU IVDR Implementation – MDCG Guidance Providing Clarification on First Certification of Type of Device Revised Version Published A revised... EU IVDR Implementation – MDCG Guidance Providing Clarification on First Certification of Type of Device Revised Version Published
