The MHRA’s predecessor, the MDA, was a driving force in the creation of the GMDN in the 1990s and has used it on a voluntary basis ever since. In 2018 the MHRA implemented the compulsory use of GMDN for all low risk device registrations, as required by the existing European single-market directives. Following the vote for Brexit a decision was made by the UK Government not to adopt the new EU regulations for medical device safety (MDR/IVDR) and instead create a ‘dynamic, fit for the future regulatory system capable of adjusting for future innovation’.
The UK framework will continue to recognise the existing EU CE marking directives for an extended period to allow manufacturers to transition to the new UK regulations, which are still being developed. The MHRA has already announced the requirement for manufacturers to enter all their product descriptions into the Device Online Registration System (DORS) from 1st January 2021 to give them a complete view of the devices for sale on the UK market. This database will be accessible to the public to meet the growing need of stakeholders to find more accurate information about the devices they use and supports recommendations from the recent Cumberlege review on effective medical device regulation.
Regulatory divergence is undesirable as it introduces additional or duplicated business processes and therefore usually increased cost, as well as creating more possibilities for divergent interpretation which may translate into increased risks for patients. But in this example, it is the European Commission that has decided to ignore the IMDRF Guidance on the use of GMDN in their preference for the Italian ‘Classificazione Nazionale Dispositivi medici’ (CND) to support their new regulatory framework (MDR/IVDR).
Most other IMDRF members, including USA, Canada, Australia, Brazil and Russia, all use the GMDN, which should allow them to aggregate data and benefit from their shared experience from large population studies, just like we do with medicine and vaccine trials. The MHRA may apply for the UK to be an independent member of IMDRF in the future, thereby facilitating access to the larger group of countries that have already harmonised their regulations covering device identification. This could allow more efficient comparison of clinical data for a new design of hip joint implanted in a patient in Oxford with one used in a patient in Melbourne. This pooling of results is expected to reduce the time needed to introduce new medical technology, while keeping the highest standards of safety.
Meanwhile in the EU, the new and complex EUDAMED device database will be in a testing phase until at least May 2022 and some manufacturers will be reluctant to submit data until then or as we have seen in the US FDA GUDID system, towards the end of the following 18-month submission window. It therefore means the accurate identification of devices using EUDAMED won’t be available to fully support patient safety in Europe until nearly in 2024.
Fortunately, from next year the use of the GMDN as part of a UK-wide Medical Device Information System (MDIS) will provide a national resource for hospitals and patients and suppliers with a better way to identify and manage the medical technology they use. As we all know, better data makes better decisions.
More information can be found at https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk