ECから7/13付で、医療機器認証機関Notified Bodiesのガイダンスおよび改訂が複数発出されています。
関係者および興味のある方は、下記URLsのガイダンス等をご参照ください。
lGuidance「MDCG 2020-11 Guidance on the renewal of designation and monitoring of notified bodies under Directives 90/385/EEC and 93/42/EEC to be performed in accordance with Commission Implementing Regulation (EU) 2020/666 amending Commission Implementing Regulation」
https://ec.europa.eu/docsroom/documents/41421
lAmendment「Amendment to Implementing Regulation 920/2013 on the designation of notified bodies」
https://ec.europa.eu/docsroom/documents/41402
lSurvey「Survey on availability and capacity of notified bodies to carry out conformity assessments for COVID-19 essential devices」
lSurvey「Survey: Notified bodies' availability and capacity to carry out conformity assessments for COVID-19 essential devices」～2点、ほぼ同タイトルで掲示されていますが、同URLで区別がつきません。
https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_survey-conformity-assess-covid-19.pdf
関係者および興味のある方は、下記URLsのガイダンス等をご参
lGuidance「MDCG 2020-11 Guidance on the renewal of designation and monitoring of notified bodies under Directives 90/385/EEC and 93/42/EEC to be performed in accordance with Commission Implementing Regulation (EU) 2020/666 amending Commission Implementing Regulation」
https://ec.europa.eu/docsroom/
lAmendment「Amendment to Implementing Regulation 920/2013 on the designation of notified bodies」
https://ec.europa.eu/docsroom/
lSurvey「Survey on availability and capacity of notified bodies to carry out conformity assessments for COVID-19 essential devices」
lSurvey「Survey: Notified bodies' availability and capacity to carry out conformity assessments for COVID-19 essential devices」～2点、ほぼ同タイトルで掲示されていますが、
https://ec.europa.eu/health/
執筆者について
経歴 ※このプロフィールは掲載記事執筆時点での内容となります
コメント
/
/
/
コメント