体外診断医療機器規制 (IVDR) (2017/746) の共同実施および準備計画

2021年6月7日に、「Joint implementation and preparedness plan for Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)」が発出されました。

2020 年 9 月の時点でのIVDRの実施の優先順位を再評価し、EU加盟国と欧州委員会の共同計画を示したホワイトペーパーです。
本文書には適用日(2022年5月26日)までにIVDR運用システムを整備するための具体的な優先行動が含まれています。

詳細は上記リンクからご確認ください。

邦訳はこちらをご覧ください。(株式会社オフィスヴィレッジのHPに移ります。)

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