End of year message from BSI 

2020 has been a challenging year for all of us. Despite the global COVID-19 pandemic, we stayed true to our values and mission of ensuring patient safety and bringing innovation timely to market. Hear from Dr Manuela Gazzard, Group Director, Regulatory Services, BSI about her thoughts on 2020 and the year ahead.                                                    Watch Video >

[2021년 1월 12일 웹세미나] UKCA for Medical devices and IVDs, are you ready? (영어로 진행)

Join BSI’s Dr Jayanth Katta, Head of UK Approved Body, Regulatory Services, to hear the latest updates on Brexit and the new UK Conformity Assessed (UKCA) mark for medical devices. The Medicines and Healthcare products Regulatory Agency (MHRA) has published new guidance on GOV.UK, please review the material directly.

This webinar will introduce BSI’s plans as a UK Approved Body and confirm the next steps for manufacturers to ensure continued access to United Kingdom market from January 2021. This is the second BSI webinar on UKCA; if you would like to listen back to the first, it can be found here. 

Please join us for this critical update around UKCA for Medical devices and IVDs on Tuesday 12 January 2021: 
웹세미나 신청은 하기 버튼을 클릭해주시기 바랍니다. 본 세미나는 영어로 진행 예정이니 참조 부탁드립니다. 

2021년 1월 12일 (오후 6.00 – 7.00 한국시간) – Register for webinar

​​​​​​​​​​​* 웹세미나 관련 문의는 본 메일에 회신 혹은 하기로 문의 부탁드립니다. 
  – BSI마케팅팀: 02. 6271. 4014/4073 (minjo.kim@bsigroup.com, songmi.heo@bsigroup.com)
* 의료기기 지침/규정 관련 인증은 하기로 문의 부탁드립니다. 
   – RS팀: 02. 6271. 4021 (hyunjung.koo@bsigroup.com) 

​​​​ IVDR and MDR Article 16: Cases in which obligations of manufacturers apply to importers, distributors or other persons

Importers and Distributors who carry out activities such as repackaging a device or translate labelling will require certification under Article 16 of IVDR and MDR. If this applies to you, then you will need certification by the date of application, 26 May 2021 under MDR and 26 May 2022 under IVDR.  

We encourage you to read Article 16 in full, and we would like to highlight the wording from the regulations:

Within the same period of 28 days, the distributor or importer shall submit to the competent authority a certificate, issued by a notified body designated for the type of devices that are subject to activities mentioned in points (a) and (b) of paragraph 2, attesting that the quality management system of the distributor or importer complies with the requirements laid down in paragraph 3.We are awaiting clarification from the European Commission for the exact requirements for the Article 16 certificate. However, the timelines are short, and we wanted to ensure you have considered the implications of this article. We will communicate with you again in January to ask for your feedback around the volume of Article 16 certificates BSI should expect to receive before the date of applications.

Listen back to our most recent webinars       

Clinical evaluation under the MDR – do you understand the requirements? Richard Holborow, Global Head of Clinical Compliance

ISO 20916 IVD – Clinical  performance studies Dr Marco Rost,  Training Lead Regulatory Service (IVD)

Our useful resources from 2020

We are committed to providing you with access to information that helps you stay up to date with all of our available services, the latest regulatory changes, and guidance on completing your applications for conformity assessment under the IVDR and MDR. These are some of the most popular resources from the last year we thought might be useful for you:

Brochures

• Active Medical Devices brochure
• AIMD Medical Devices brochure
• MDR Best Practices Guidelines and MDR Conformity Assessment Routes Guide​​​​​
• IVDR Best Practices Guidelines and IVDR Conformity Assessment Routes Guide
• Your IVDR application to BSI
• Your IVDR Transition Toolkit​​​​​​ 

Webinars
Our webinars focused on a range of topics in 2020, from clinical evaluation under the MDR and performance evaluation under the IVDR, to IVDR conformity assessment routes and symbols to be used on labelling for your medical device. All of our webinars are available on our website, where you can listen back on these and other topics.

Whitepapers
These provided thought leadership on current industry trends, including medical device clinical investigations under the MDR, risk management for medical devices and software as a medical device. Visit our website for more information.

We are committed to providing you with access to information that helps you stay up to date with all of our available services, the latest regulatory changes, and guidance on completing your applications for conformity assessment under the IVDR and MDR. These are some of the most popular resources from the last year we thought might be useful for you:

Have you read the latest Compliance Navigator blog posts

If you’d like to stay up to date with the latest regulatory, technological and standards-related developments within the medical devices sector, then subscribe to the Compliance Navigator blog. Written by industry experts, blog posts are published once every two weeks.
Read blog posts >

We trust you have a safe and happy holiday from all of us at BSI