June 13th 2019 Lloyd’s Register Quality Assurance (LRQA) announced its withdrawal as Notified Body under the current Medical Device and IVD Directives and that it will not apply for designation under the Medical Device Regulations (MDR) and IVD Regulations (IVDR).
LRQA has informed their clients of this decision and has requested them to choose an alternative notified body. Clients have been given a 90-day notice period. LRQA made it clear that they will cease all notified body services at the end of this 90-day period, regardless of whether the transfers have been completed or not.
LRQA will continue to provide ISO 13485 and Medical Device Single Audit Program (MDSAP) third party certification and medical devices-related training to clients both in the UK and worldwide.
What does this mean to you?
If you were working with LRQA as your notified body you will need to take immediate action to appoint a new notified body for your products to ensure that you can continue placing your devices on the European market.
Under the upcoming MDR and IVDR it means that it is one less notified body to handle the increased number of applications.
Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.
