“Navigate your way through the regulatory grey.” That was the tagline for the 2019 Regulatory...

First European Notified Body designated to issue CE Marking under IVDR announced

EMERGO BY UL SUMMARY OF KEY POINTS: The European Medical Device Coordination Group (MDCG) plans to use Italy’s CND codes as the basis for the Eudamed device database nomenclature. CND codes will be mapped to Global Medical Device Nomenclature (GMDN) for ease of use. Using CND nomenclature provides public access to medical device codes within Eudamed.

Although questions of when (and even if) Brexit occurs remain open, UK and European markets...

Emergo关键点摘要： MDR、IVDR的实施仍在按计划进行中。 第一批指定的公告机构可能会在2018年底前公布。 Eudamed如期推进。 英国脱欧是一个值得关注的问题，但英国所有的公告机构似乎都在采取适当的应对行动。

このニュースのポイント： MDR、IVDRの実施は計画通り進行しています。 指定される最初の公認機関は、2018年末までに発表される可能性があります。 Eudamed（欧州医療機器データベース）は計画通りに進んでいます。 Brexit（英EU離脱）は懸念事項ですが、英国を拠点とするすべての公認機関が適切な措置を取っているようです。

EMERGO SUMMARY OF KEY POINTS: Second update IN 2018 of the Manual on Borderline and Classification. Five new cases added, providing useful illustrations of how the definition of a medical device and the classification rules should be understood. For the MDR there could be some significant differences.

このニュースのポイント： 2018年に、ボーダーラインと分類に関するマニュアルの2度目の更新が行われました。 5つの新たな事例の追加により、医療機器の定義と分類規則をどのように理解すべきかというテーマに有用な例証を提供します。 MDRに関しては重要な相違点がある可能性があります。

EMERGO BY UL SUMMARY OF KEY POINTS: MHRA will take on responsibility for the UK market; The CE Mark remains valid in the UK and no label changes are foreseen for now; MDR and IVDR will be implemented in the UK in parallel with the EU Non-UK manufacturers placing devices on the UK market need to appoint a UK Responsible Person, a role similar to that of the European Authorized Representative The UK-based manufacturer or the UK Responsible Person must register the device in the UK.

EMERGO BY UL 핵심 요약: 영국 의약품 및 보건의료제품 규제청(MHRA)이 영국 시장을 담당할 예정입니다 CE 마킹은 영국 내에서 여전히 유효하며, 현재 라벨 변화는 예고된 바 없습니다 MDR 및 IVDR이 EU와 영국에서 나란히 시행될 예정입니다 영국 의료기기 시장에 진출한 영국 외 제조사는 영국 책임자를 임명해야 하며, 이는 유럽 공인 대리인의 역할과 비슷합니다 영국 기반 제조사 또는 영국 책임자는 기기를 영국에서 등록해야 합니다.