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Medicines & Healthcare Products Regulatory Agency

MHRA Issues Guidance on Re-manufacturing Single-use Medical Devices

The Medicines & Healthcare products Regulatory Agency (MHRA) recently released a new guidance document titled “Single-use medical devices: UK guidance on re-manufacturing” published on July 5, 2016 for the purpose of making a clear distinction between re-manufactured single-use devices (SUDs) and devices that are reprocessed or fully refurbished.

取引なしのEU離脱に関するMHRAのガイダンス

EMERGO by UL このニュースのポイント

  • MHRAは英国市場を担います。
  • CEマークは英国でも有効であり、今のところラベルの変更は予見されていません。
  • MDRとIVDRは、EUと並行して英国で実施されます。
  • 英国市場に機器を配置する英国以外の製造業者は、欧州の認定代理人と同様の役割をする英国の責任者を任命する必要があります。
  • 英国を拠点とする製造業者または英国の責任者は、機器を英国に登録する必要があります。

MHRA关于无协议脱欧的指南

EMERGO BY UL关键点摘要:

  • MHRA将负责英国市场的监管;
  • CE标志在英国仍然有效,目前预计不会有变化;
  • 英国将与欧盟同步实施MDR和IVDR
  • 在英国销售器械的非英国制造商需要任命一位角色类似于欧盟授权代表的英国负责人
  • 英国制造商或英国负责人必须在英国注册器械。

노딜 브렉시트에 대한 MHRA 지침

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.

MHRA Guidance on a No-Deal Brexit

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.

UK Medical Device Regulators Introduce “Virtual Manufacturing” to Replace OBL

EMERGO SUMMARY OF KEY POINTS:

  • The UK’s Medicines & Healthcare Products Regulatory Agency (MHRA) has redefined Own Brand Labeling (OBL) manufacturers as “virtual manufacturers.”
  • UK regulators will begin requiring virtual manufacturers to hold full technical documentation of devices they sell in Great Britain starting September 1, 2017.
  • Any redacted technical documentation from virtual manufacturers due to proprietary data concerns will have to be justified to UK regulators.

MHRA Issues Guidance on Medical Device Standalone Software

On August 25, 2016, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) issued a guidance covering “Medical device stand-alone software including Apps.” The guidance is applicable to the current medical device directives 93/42/EEC and may be replaced when the new EU Medical Device Regulations are put into force.

Orientation de la MHRA en cas de Brexit sans accord

Par Ronald Boumans

LES POINTS PRINCIPAUX PAR EMERGO by UL :

  • La MHRA assumera la responsabilité du marché britannique ;
  • Le marquage CE reste valable au Royaume-Uni et aucune modification du label n'est prévue pour le moment ;
  • Le RIM et le RDIV seront mis en œuvre au Royaume-Uni en parallèle avec l'UE
  • Les fabricants non britanniques qui mettent des dispositifs sur le marché britannique doivent désigner une personne responsable au Royaume-Uni, un rôle similaire à celui du représentant autorisé européen
  • Le fabricant basé au Royaume-Uni, ou la personne responsable au R-U, doit enregistrer le dispositif au Royaume-Uni.