UK regulator offers conditional grace period for medical device companies...
Title: UK regulator offers conditional grace period for medical device companies changing Notified Bodies
View ArticleChallenges for successful medical device clinical monitoring
Title: Challenges for successful medical device clinical monitoringByline: Dietmar Falke, PhD
View ArticleMDR Watch: New Joint Implementation plan as multiple challenges to Regulation...
Title: MDR Watch: New Joint Implementation plan as multiple challenges to Regulation compliance arise
View Article欧州議会がMDR適用期限の延期を公式に支持表明
欧州議会がMDR適用期限の延期を公式に支持表明(原案記載分：2020年4月22日） 欧州議会は、今後の引き続き予想される大きな動きの中で、医療機器規則の適用日を医療当局、政府および業界がCOVID-19の緊急事態と取り組むため、1年間延期するという欧州委員会の提案を採択しました。Read more
View ArticleEuropean Commissioners loosen some MDD, AIMDD designation renewal...
European Commissioners loosen some MDD, AIMDD designation renewal requirements for Notified BodiesEuropean Notified Body designation renewals eased ahead of new MDR date of applicationRead more
View ArticleMDR Second Corrigendum: Grace period for some self-certified Class I medical...
MDR Second Corrigendum: Grace period for some self-certified Class I medical devices On December 3rd, 2019 the European Parliament adopted the second corrigendum of the MeRead more
View ArticleMDR watch: Compliance deadline for upclassified Class I medical devices...
MDR watch: Compliance deadline for upclassified Class I medical devices pushed to 2024?Proposed changes to European MDR would extend deadlines for some Class I devices to 2024Read more
View ArticleMedica 2019 report: MDR readiness checklist ahead of May 2020 deadline
Medica 2019 report: MDR readiness checklist ahead of May 2020 deadlineWith the European Medical Devices Regulation (MDR) compliance a dominant topic at the Medica 2019Read more
View ArticleLe GCDM européen prend en compte les questions de certification des...
Le GCDM européen prend en compte les questions de certification des dispositifs médicaux existants et le RDMNouveau document directeur sur la certification des dispositifs existants dans le cadre de la...
View ArticleEuropean regulators update Q&A resource for Notified Body requirements ahead...
European regulators update Q&A resource for Notified Body requirements ahead of MDRUpdated resource from European Medical Device Coordinating Group (MDCG) on Notified Body requirements under MDR,...
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