UKCA 및 CE마크 주요 업데이트- 향후 영국의 의료기기 및 체외진단규정

MHRA에서 EU Transition Period가 완료되는 2021년 1월부터 의료기기와 체외진단기기를 규제하는 방법을 설명하는 새로운 가이던스를 GOV.UK에 발행했습니다. 현재 BSI는 MHRA 가이던스에 대해 명확성을 확보하기 위해 세부사항을 검토 중입니다. 주요 사항은 아래 내용과 같습니다.

주요 내용 살펴보기

새롭게 도입되는 MDR 및 IVDR 규정은 영국에서 시행되지 않습니다. 이 규정들은 각각 2021년 5월 26일과 2022년 5월 26일부터 EU 회원국에 완전히 적용이 될 것이고, Transition period가 종료될 때까지 발효되지 않을 것입니다. 다만, MDD/AIMDD/IVDD 지침은 2021년에도 영국에서 지속적으로 적용됩니다.
영국 시장 진출에는 새로운 적합성 마크인 UKCA 마크를 도입합니다. UKCA 마크는 2021년 1월 1일부터 영국 시장에 출시 될 의료기기를 포함한 특정 상품에 사용되는 새로운 영국 제품 마크입니다.
2023년 6월 30 까지 CE 마크를 계속 인정합니다. UKCA 마크는 2021년 1월 1일부터 제조업체가 사용할 수 있지만, 2023년 6월 30일까지는 CE 마크를 허용할 것입니다. 이를 통해, 업계에서는 영국 시장에 진출할 수 있는 시간과 새로운 요구사항에 적응할 수 있는 시간을 확보하여, Transition period 이후에도 환자들에게 지속적으로 안전한 장치를 제공할 수 있습니다.

BSI와 같이 기존 MDD/AIMDD/IVDD 지침 하에 UK 인증기관들은 UKCA에 대해 별도 기관 지정 없이, 자동으로 기관 지정될 예정이라고 합니다. BSI UK NB(0086)도 이에 해당하며, BSI UK NB(0086)은 영국에 대한 적합성 평가를 제공하는 UKCA Approved Body으로 일할 예정입니다.

CE마크에 관한 규정은 의료기기와 다른 대부분의 산업군 제품의 일정은 다르니, 참고 해주시기 바랍니다. 추후 업데이트 되는 내용은 또 다시 공유하겠습니다.

Important update: UKCA and future UK regulation of medical devices and in vitro diagnostics

9 September 2020

BSI would like to share with you a critical announcement regarding the new UK Conformity Assessed (UKCA) mark for medical devices. The Medicines and Healthcare products Regulatory Agency (MHRA) published new guidance on GOV.UK, which sets out how medical devices and IVDs will be regulated after the transition period with the EU has ended (from 1 January 2021). We are currently working through the details and preparing questions for the MHRA to gain clarity in several areas; at this time, we would like to highlight the publication and urge you to familiarize yourself the details.

The MHRA has noted three key aspects in particular; for the full details, please refer to the GOV.UK website:

The EU Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) will not be implemented in Great Britain. As you may be aware, these Regulations will fully apply in EU Member States from 26 May 2021 and 26 May 2022 respectively and will not take effect until after the transition period has ended. They will not therefore be retained EU law as described by the EU Withdrawal Agreement Act.
The Directive 90/385/EEC on active implantable medical devices, Directive 93/42/EEC on medical devices and Directive 98/79/EC on in vitro diagnostic medical devices will continue to apply in Great Britain from 1 January 2021.
We will introduce a new UK route to market and mark of conformity for devices. The UKCA mark is a new UK product marking that will be used for certain goods, including medical devices, being placed on the Great Britain market from 1 January 2021. Our guidance provides further information on how to UKCA mark your devices.
We will continue to recognise the CE marking until 30 June 2023. Although the UKCA mark will be available for manufacturers to use from 1 January 2021, we will continue to accept CE marked devices until 30 June 2023. This will allow time for the UK route to market to embed and for industry to adapt to these new requirements, ensuring a continued supply of safe devices to UK patients after the transition period.

BSI notes that existing UK notified bodies with designations under the MDD, IVDD or AIMDD will have their designations rolled over automatically, without having to undergo a new designation process. This automatic rollover includes BSI’s UK Notified Body (0086), and we would like to confirm our intention to work as a UKCA Approved Body completing conformity assessments for the UK.

I will be running a webinar to provide you with an update and more details on this guidance on Tuesday 29 September 2020. I am pleased to be joined by Senior Vice President, Gary Slack, to discuss BSI’s strategic approach to the new regulation and how we will implement this alongside our EU Notified Body role. Please join the webinar to hear the latest information.

We will continue to monitor for further developments and will keep our webpage current. Please keep in mind that this is new information and we will be reviewing and updating our procedures to ensure we can react in the required timelines to support clients. Our priority is to maintain patient safety.

Please note for all your European market access needs, BSI’s Notified Body in the Netherlands (2797) continues to provide full-scope medical device and in vitro diagnostic conformity assessments for all EU directives and regulations.

We thank you for your support with this additional regulatory transformation.

Dr Jayanth Katta

Senior Regulatory Lead, BSI Notified Body

글로벌 웹세미나 9/29 10pm (영어 진행)

BSI update on the new UKCA and future UK regulation for Medical Devices and IVDs

● 제목: New UKCA and future UK regulation for medical devices and IVDs

● 일시: 29 September 2020 10:00 PM KST(한국 시간)

● 내용:
1. The introduction of the new UK route to market and the mark of conformity for devices.
2. The transition period for products already CE marked, following confirmation of recognition of the CE mark until 30 June 2023.
3. The implications of Great Britain not implementing the EU Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR). 4. Outline of how the requirements will impact manufacturers in the UK and EU.