OLS Survey on HealthTech Industry OLS Survey on HealthTech Industry The Office for Life Sciences has commissioned a... OLS Survey on HealthTech Industry
Harmonised Standards for MDR and IVDR Published Harmonised Standards for MDR and IVDR Published The European Commission has published a list of references of harmonised European standards... Harmonised Standards for MDR and IVDR Published
39th Notified Body has been designated under the EU MDR Cyprus based Notified Body ‘G.F.I. Health Technology Certification Ltd` has been notified as the 39th Notified Body under the MDR... 39th Notified Body has been designated under the EU MDR
Future Medical Device Regulations Update – July 2023 Future Medical Device Regulations Update – July 2023 The Government has now put in place measures to provide that CE... Future Medical Device Regulations Update – July 2023
MDCG Position Paper on the Application of Art. 97 MDR – Addendum Published MDCG Position Paper on the Application of Art. 97 MDR – Addendum Published The Commission has published an addendum to... MDCG Position Paper on the Application of Art. 97 MDR – Addendum Published
PFAS – ECHA Restriction Proposal PFAS – ECHA Restriction Proposal The European Chemicals Agency (ECHA) restriction proposal for per- and polyfluoroalkyl substances... PFAS – ECHA Restriction Proposal
UK Medical Device Regulation – Update for Class I UK Medical Device Regulation – Update for Class I MHRA has formally updated their guidance on the website to provide... UK Medical Device Regulation – Update for Class I
EUDAMED – Production Release 2.11 EUDAMED – Production Release 2.11 EUDAMED is the IT system developed by the European Commission to implement... EUDAMED – Production Release 2.11
Professor Dame Angela McLean’s Review on Pro-innovation Regulation for Life Sciences and the Government Response Professor Dame Angela McLean’s Review on Pro-innovation Regulation for Life Sciences and the Government Response On 26 May HM Treasury... Professor Dame Angela McLean’s Review on Pro-innovation Regulation for Life Sciences and the Government Response
New Life Sciences Vision – Government Announcements New Life Sciences Vision – Government Announcements The Government has made a series of announcements to boost the life sciences... New Life Sciences Vision – Government Announcements
MHRA Guidance – Latest Updates MHRA Guidance – Latest Updates MHRA has shared a list of latest medical devices guidance updates highlighting, subject to parliamentary... MHRA Guidance – Latest Updates
Submitting Adverse Incidents to Medical Devices to MHRA – Enhancements to the MORE Portal Submitting Adverse Incidents to Medical Devices to MHRA – Enhancements to the MORE Portal MHRA has announced some upcoming changes... Submitting Adverse Incidents to Medical Devices to MHRA – Enhancements to the MORE Portal
