2001年7月に発表されたEU医療機器等級(クラス)分類ガイドラインMEDDEV 2.4/1 rev 8.が更新、MEDDEV 2.4/1 rev 9.が発表されました。

最新ガイドライン→ MEDDEV_2.4_1_Rev.9.pdf 

The present MEDDEV is part of a set of guidelines relating to questions of application of EU Directives on medical devices. They are not legally binding. Only theEuropean Court of Justice can give an authoritative interpretation of Community Law.
This MEDDEV contains guidance for the application of the classification rules for medical devices as set out in Annex IX of Directive 93/42/EEC1, as amended. It is for the national Competent Authorities and national Courts to take legally binding decisions on a case-by-case basis.