This following would apply to members based in Northern Ireland conducting these tasks, or members distributors, performing these tasks in the EU: Article 16(4) Certification Scheme As part of BSI’s commitment to ensuring patient safety while supporting timely market access to global medical device technologies, we are pleased to inform you that we are expanding our Notified Body services to…
Ben KempOctober 1, 2024
CLSI EP47 provides guidance for planning, performing, evaluating, and documenting reagent carryover experiments and guidance for ensuring that no significant reagent carryover occurs. This document is intended for developers of in vitro diagnostic tests, regulatory organizations, and medical laboratories. Price: $180 for PDF; $200 for Print Access it here.
Ben KempSeptember 25, 2024
CLSI have published EP47 Evaluation of Reagent Carryover effects on test results 1st Ed: https://www.linkedin.com/posts/clsilabnews_ep47-standards-lablife-activity-7242219650338410496-1aG5?utm_source=share&utm_medium=member_android
Ben KempSeptember 25, 2024
Team NB, the EU Notified Body association, have published version 5.0 of their code of conduct for Notified Bodies. You can find it here.
Ben KempSeptember 24, 2024
Do you use EPO Online Filing (eOLF)? Things are changing on 30 September! From 1 October 2024, you will no longer be able to renew eOLF Smart Cards that have expired. To continue filing with the IPO via eOLF, you will need to replace your smart card with a ‘soft certificate’. From 1st January 2025, valid smart cards will no…
Ben KempSeptember 18, 2024
As part of BSI Regulatory Services, Medical Devices commitment in maintaining IVDs manufacturers up to date on the EU regulatory framework developments, we issue this communication in regard of the rollout of EU Reference Laboratories and oversight of Class D IVDs in Europe. On 5 December 2023, five EU reference laboratories (EURLs) have been designated through Commission Implementing Regulation (EU)…
Ben KempSeptember 18, 2024
Pakistan’s Competent Authority has published revised fees: S.R.O. 1324(l)12024 – Revision of Regulatory Fee Notification – Drug Regulatory Authority of Pakistan (dra.gov.pk)
Ben KempSeptember 18, 2024
Team NB have developed a position paper and template for the transfer of surveillance of legacy devices. This tripartite agreement template is regarding the transfer of responsibilities between notified bodies for certified IVD legacy devices subject to transitional arrangements, under the EU IVDR Article 110 You can find the paper here.
Ben KempSeptember 17, 2024