Important Regulatory Update
Please be advised that the MatOrtho Quality Management System is now certified by the British Standards Institution (BSI).
The MatOrtho ISO 13485 and CE marking certificates were previously issued by LRQA. Since September 2019, when LRQA withdrew their Notified Body service, the UK regulator MHRA has allowed MatOrtho to continue to sell approved products as CE Marked devices under MHRA oversight. This permission allows MatOrtho to transfer to a new Notified Body. The transfer process has been more complex than would normally be the case due to uncertainty over the timings of Brexit and the changes in EU regulations from the Medical Device Directive (MDD) to the Medical Devices Regulations (MDR).
As the first part in transferring to a new Notified Body, MatOrtho has transferred the ISO 13485:2016 Quality Management System to the BSI. Our new ISO 13485:2016 certificate MD 731697 can be obtained via your company representative.
MatOrtho continues to work with BSI on the CE Marking transfer and the MHRA oversight remains in place.
BSI is the Notified Body for most of the largest global orthopaedic device companies. BSI Notified Body Number 2797 in The Netherlands in the EU is already designated for MDD and MDR. It is expected that MatOrtho will appoint an Authorised Representative based in the EU by 31st December 2020 when the transition period ends, the UK having already left the EU.