Emergo重点摘要： 欧洲与英国谈判人员达成了一项交易 过渡期到2020年12月31日为止。额外的21个月 MDR将在英国适用；IVDR很可能也将如此。 英国和欧盟之间的一份双边协议将让两地之间的医疗器械可以自由流通，但是这在政治上是否行得通尚不得而知

EMERGO SUMMARY OF KEY POINTS: European and UK negotiators strike a deal Transitional period until 31 December 2020: 21 months extra The MDR will apply in the UK; it is likely this will also happen for the IVDR A mutual agreement would enable movement of medical devices between the UK and EU, but whether this is politically achievable remains unknown

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.

How the UK REP role may affect UK market access following a no-deal Brexit

En raison du Brexit et de questions telles que l'application du RIM et du RDIV, LRQA arrête des activités d'organisme notifié.

Issues including MDR and IVDR implementation, Brexit led to LRQA’s withdrawal as NB

Par Stewart Eisenhart LES POINTS PRINCIPAUX PAR EMERGO by UL : La TGA australienne a élaboré des plans pour atténuer l'impact du Brexit sur le marché australien des dispositifs médicaux. La TGA continuera à reconnaître les évaluations de conformité des organismes notifiés basés au Royaume-Uni pour les listes et les applications ARTG existantes et nouvelles. Les effets à court terme d'un éventuel Brexit souple ou bien sans accord devraient être minimisés par les mesures de la TGA telles que décrites.

EMERGO BY UL SUMMARY OF KEY POINTS: The Australian TGA has drawn up plans to blunt the impact of Brexit on the country’s medical device market. TGA will continue recognizing conformity assessments from UK-based Notified Bodies for existing and new ARTG listings and applications. Short-term effects of a potential orderly or no-deal Brexit should be minimized by TGA measures as described.

Par Ronald Boumans À un mois du Brexit Day, les entreprises de matériel médical actives...