Notified Body Capacity; Serious Deterioration And Risk To UK Patients And Manufacturers Update
Dear member,
Following my recent communication to you, regarding notified body capacity after the withdrawal of Lloyd’s Register Quality Assurance Ltd. (LRQA) from the medical devices space, I wanted to update you on our work.
Our number one priority is to have a clear roadmap for companies as we transition to the new Medical Device Regulation (MDR), which must include mitigation against the acute shortage of notified body capacity. We have also highlighted that the situation will be exacerbated as we get closer to the transition period for IVDR, when a large number of diagnostic companies will be using notified bodies for the first time. This will be an important part of the work of our Diagnostic Group.
To help our stakeholders better understand the implications of this crisis, we are compiling a list of case studies and I am grateful for the support of those of you who have contributed so far. We are always keen to hear further examples of the issues you face.
Our Regulatory Director, Phil Brown, is in close contact with the Medicines and Healthcare Products Agency (MHRA), which continues to monitor the situation carefully. It is important that members who are experiencing difficulties in their communications with LRQA, or any other notified body, contact MHRA directly using the email address devices.support@mhra.gov.uk. If you do not receive a timely or appropriate response, please inform me such that I can escalate as appropriate.
We have a large number of stakeholders, including Royal Colleges, NHS organisations and Embassies alerted to the situation, and an internal crisis team updating me personally on a daily basis.
Last week we highlighted the European joint letter that will be sent to national Ministers expressing our concerns. We seek as many signatures as possible before the deadline of Thursday 18th July, 12:00pm. To support this, please provide your name, job title and electronic signature to: richard.phillips@abhi.org.uk
If you need any further assistance of clarification please do not hesitate to contact me. I will continue to keep you updated.
