MEDICAL DEVICES
New UK medical device regulation spells potential trial concerns for some IVD players
Forthcoming UK medical device regulations have an uncertain date but draw some praise along with caution, says Jennifer Smith-Parker.
T
he anticipation of new medical device- related regulations in the UK has led to some concerns that additional pre-
market clinical or post-market surveillance data would be overly burdensome. As GlobalData found, the additional data
challenge for smaller in vitro diagnostics (IVD) manufacturers whose market is essentially only in the EU, says Andrew S Thompson, PhD, director of therapy research & analysis at GlobalData. However, the requirement for additional clinical data is not that big a shock to most device manufacturers, says Eamonn McGowran, associate director for regulatory affairs at Boyds consultants. The UK’s exit from the EU has meant the area is not beholden to the new European Medical Device Regulation (MDR), which has replaced the current Medical Devices Directive (MDD). UK law still relies on the less-rigorous MDD as the basis for medical device marketing rules. Thus, neither the MDR nor companion rules like the In Vitro Diagnostics Regulation (IVDR) will have a direct effect on the availability of medical devices in the UK.
The EU MDR and IVDR regulations became effective in May 2017 but to allow time for companies to acclimate to the new requirements, the regulations became applicable over a transition period. The MDR had originally provided a three-year transition period (becoming operational in May 2020), however, due to COVID-19 full application of the MDR was extended to 26 May 2021. Similarly, the IVDR became fully applicable
transition period.
IVD sector adjusting to the regulation, the Europeans published a proposal to postpone the full application deadline.
British regulation will tighten up At some point, the UK will also likely introduce new medical device regulations, based on the which reported on the harmful effects of some medicines, interventions and devices on female health, explains Thompson. The British government is likely to continue to consult with medical device stakeholders such as manufacturers, healthcare providers and patient advocacy groups, to develop these new regulations. “The UK has always had a strong role
in device development and regulation,” McGowran says. Amendments to create the new regime are scheduled to be in force at the beginning of July 2023. This will align with the date from which the UK is due to stop accepting CE-marked medical devices in Great Britain and will require the use of the UK Conformity Assessed marking (1 July 2023). The EU MDR has brought regulatory requirements for devices to a higher standard previously used for devices has changed, explains McGowran. It would seem the UK could likewise raise the standards in its own consultation process in order to maintain own regulatory bubble,” Thompson says. Such changes will be felt across the industry.
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