Notified Body Capacity: Latest Update
Notified body capacity, and its impact on the implementation of MDR, remains a critical priority for our Association. We continue to push hard to mitigate against the risk of companies being unable to place products on the market after May 2020.
As detailed in my recent communication to you, a European joint letter was circulated among business leaders last week. 135 signatures were gathered in that period, from both multinationals and SMEs, demonstrating the shared concern across industry for this important issue. The letter has now been sent to Ministers of Health and Economy across the European Union, seeking measures to alleviate the current scenario.
We have shared this with UK government, including Baroness Blackwood, Parliamentary Under Secretary of State, who has raised the issue during recent meetings with Ministers. We continue to work with government to convey the very real risk this situation presents to the continued supply of products to patients.
I have also had discussions in Brussels, the US and with the US Embassy in London, to gather support for a resolution.
Thank you to those companies who have provided case studies to help support our engagements. These tangible examples are particularly useful in ensuring our stakeholders are fully aware of the issue. To support this effort, please complete this template and submit your case study to phil.brown@abhi.org.uk by Wednesday 31st July. Phil remains in daily contact with the MHRA and is sharing these case studies as appropriate.
I will continue to keep you updated as the situation develops.
