By Nancy Consterdine, Director of Operations, IVDeology Ltd
So, we’ve been waiting patiently for months to find out the governments view on the consultation details. We were teased with various dates, told that local elections were the reason for the delay and then finally it was released by stealth on a Sunday! It is important to remember this is not the final regulation it is the government commenting on the majority responses from the consultation which should at least give an indication of what we can expect from the final regulation in the coming months.
On initial reading it does appear that the UK MDR will be closely aligned to the EU IVDR, even if terms and descriptions do not directly reference that regulation. For us there are 5 standout items in the extensive and detailed commentary
UK Responsible Person
The UK Responsible Person requirement is established, this has been a requirement since January 2021 and the government have confirmed this will continue to be a requirement. There was whisperings that this was going to be rolled back, however this requirement has remained.
The UKRP must also have a permanent location in the UK at which they are physically located, which will exclude those currently located outside the UK but using a forwarding address. In addition to this they have directed that this function must have a Qualified Person continually and permanently at their disposal. Manufacturers are also required to have a Qualified Person in place. We’re very happy to report IVDeology UKRP Ltd qualifies going forward and will continue to support our customers in offering our friendly and flexible UKRP service!
The UK will move to a 4 level (A – D) risk-based classification system for in vitro diagnostic devices based on the IMDRF document “Principles of In Vitro Diagnostic (IVD) Medical Devices Classification” This is aligned to the EU IVDR but may see subtle differences in practice with a small number of devices moving between classifications, this includes Genetic tests and Companion Diagnostics. This requires further review and investigation.
Greater controls over “in-house” manufactured or modified devices will be introduced to the extent that the health institution must have a full Quality Management System in place, the device must follow the relevant essential requirements of the UK MDR and must register those devices with the MHRA. There has long been a need to control the use of such devices and there should be a route for these institutions to access support in building their QMS and documenting the device technical information.
We are expecting the new update to ISO15189 in the coming months so it will be interesting to see how this fits into the new regulation.
There will be a new Great Britain Registration database which will be more comprehensive than the current MHRA DORS.
The government will be exploring how this database can operate as part of a series of integrated databases for capturing and processing information submitted to the MHRA about medical devices (such as data on registration, vigilance, post-market surveillance, and market surveillance regarding medical devices). This database will capture information around UDI and will utilise the GMDN device nomenclature system.
We broadly applaud this move towards improved traceability, hoping that the process remains robust and efficient.
The Transition arrangements for devices holding a valid EU IVDR certificate or UKCA certificate will run until expiry of that certificate or for 5 years post implementation of the UKMDR, which ever is sooner.
As with the transition to the EU IVDR if there is a change to the design leading to an update of the certificate or a change to the intended purpose then the need to comply will come into force. Equally, the post market requirements of the new regulations will apply immediately on full implementation.
As already stated, this is not the new regulation, only an indication of the direction the UK government is taking from the responses and statements delivered via the consultation. It is clear that they are looking to ensure access to the UK market for safe and effective devices is controlled but not impossible to attain.
IVDeology is always happy to talk to manufacturers outside of GB and NI about their UK Responsible Person requirements, this is already a regulatory requirement that manufacturers should have in place. Equally if you are not satisfied with the service you are being provided at the moment or that your current UKRP will not meet the requirements stated in point 1 please get in touch!
If you are interested in discussing further what the new UK MDR could mean to your organisation going forward and thinking about initial preparation for transition please do get in touch at firstname.lastname@example.org or book a virtual meeting with Nancy or Stuart to discuss further.