Sustainable finance

This subtopic contains the following documents:

Practice Notes

  1. Climate change and sustainability issues for the EU financial sector—analyses the key risks that climate change poses to the EU financial sector

  2. The EU sustainability-related disclosure regulation (EU SFDR)—essentials—analyses the scope and requirements of the EU

To view the latest version of this document and thousands of others like it, sign-in with LexisNexis or register for a free trial.

Powered by Lexis+®
Latest EU Law News

MedTech Europe publishes Reflection Paper calling on reform of diagnostic device sampling for certification

MedTech Europe has published a Reflection Paper calling on the Medical Device Coordination Group (MDCG) to adopt a risk-based, rather than quota-based, sampling approach for Class B and Class C devices to reduce the burden stemming from duplicative sampling and focus the resources of the system on higher risk devices.​ The industry body emphasises that in vitro diagnostic (IVD) device manufacturers have increased technical documentation and administrative burden under the Regulation (EU) 2017/746 (IVDR). Notified Bodies dedicate most of their time in sampling lower risk Class B and Class C devices, rather than highest risk Class D devices. Class B and C diagnostics together make up over 90% of the EU IVD market. The Paper notes that the average number of samples taken under IVDR is more than double that under the Medical Devices Regulation (MDR), due to broader scope codes and more grouping categories for IVDs. ​MedTech Europe in this Paper argues that the current system leads to repetitive sampling of the same devices, particularly for SMEs with limited portfolios, offering little added value in terms of safety or performance assurance. The Paper argues that the mandated 15% sampling rate for technical documentation per certification cycle is disproportionate, especially when compared to the 100% review requirement for the highest-risk Class D devices. This quota-based system imposes a significant financial and operational burden on manufacturers, with average costs per technical file review nearing €38,000. ​MedTech Europe proposes a shift to a risk-based sampling model. This seems to take a page from the UK which just had the UK Government respond to a public consultation in support of future regulation that will create a more proportionate risk-based approach to diagnostic device certification that would, in particular, mean that certification of Class B IVDs for the Great Britain market would require UKCA self-declaration and ISO 13485 quality management system (QMS) certification. MedTech Europe proposes to eliminate automatic quotas for Class B devices during surveillance, reducing sampling for Class C devices to 5%, and applying a maximum of 5% sampling during initial certification for devices with stable post-market surveillance. Simulations in the paper show that such an approach would significantly reduce the total cost burden on the sector without compromising safety. The paper calls for the MDCG to revise its guidance to reflect this more proportionate, risk-based strategy

View EU Law by content type :

Popular documents