35th Notified Body has been designated under the EU MDR Czech Republic-based notified body ‘INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s.’ has been notified as the 35th Notified Body under... 35th Notified Body has been designated under the EU MDR
CAMD Statement on MDR Implementation Challenges Adopted CAMD Statement on MDR Implementation Challenges Adopted in the context of the Czech Presidency of the EU Council, during its... CAMD Statement on MDR Implementation Challenges Adopted
MDR Implementation – Speech by Commissioner Kyriakides on the Revision of MDR MDR Implementation – Speech by Commissioner Kyriakides on the Revision of MDR On 24 November, Health Commissioner Stella Kyriakides gave... MDR Implementation – Speech by Commissioner Kyriakides on the Revision of MDR
MHRA Good Manufacturing and Distribution Practice Symposia 2023 MHRA Good Manufacturing and Distribution Practice Symposia 2023 Between 21 February – 22 February 2023 MHRA is hosting the Good... MHRA Good Manufacturing and Distribution Practice Symposia 2023
Revisions of MDCG Guidance Documents on Safety Reporting in Clinical Investigations Published Revisions of MDCG Guidance Documents on Safety Reporting in Clinical Investigations Published The Commission has published a revised version of... Revisions of MDCG Guidance Documents on Safety Reporting in Clinical Investigations Published
MHRA Guidance on Borderline Products Updated MHRA Guidance on Borderline Products Updated The MHRA has updated their guidance ‘Borderline products: how to tell if your product... MHRA Guidance on Borderline Products Updated
MHRA Publishes Access Consortium Good Manufacturing Practice (GMP) Statement MHRA Publishes Access Consortium Good Manufacturing Practice (GMP) Statement In alignment with the Access Consortium’s strategic objective to expand and... MHRA Publishes Access Consortium Good Manufacturing Practice (GMP) Statement
MHRA Consultation on Proposals to Increase Statutory Fees – PAGB Response MHRA Consultation on Proposals to Increase Statutory Fees – PAGB Response MHRA is seeking views on proposals for changes to... MHRA Consultation on Proposals to Increase Statutory Fees – PAGB Response
EUDAMED – Production Release 2.9 Delayed EUDAMED – Production Release 2.9 Delayed EUDAMED is the IT system developed by the European Commission to... EUDAMED – Production Release 2.9 Delayed
MHRA Webinar – Changes to E-cigarettes: Regulations for Consumer Products Guidance MHRA Webinar – Changes to E-cigarettes: Regulations for Consumer Products Guidance MHRA has updated its E-cigarettes: Regulations for Consumer Products... MHRA Webinar – Changes to E-cigarettes: Regulations for Consumer Products Guidance
MHRA Webinar Recording – Changes to the Submission Routes for Reporting Medical Device Adverse Incidents MHRA Webinar Recording – Changes to the Submission Routes for Reporting Medical Device Adverse Incidents On Tuesday 4 October 2022... MHRA Webinar Recording – Changes to the Submission Routes for Reporting Medical Device Adverse Incidents
MHRA Guidance on Pharmacovigilance Procedures Updated MHRA Guidance on Pharmacovigilance Procedures Updated The MHRA has updated their guidance on Pharmacovigilance Procedures which summarises MHRA’s approach to... MHRA Guidance on Pharmacovigilance Procedures Updated
