Industry focus may currently be directed towards the EU with the application date of the EU MDR now under a month away, but in this article we take a look at the current regulatory landscape in the UK and consider some issues companies placing devices on the GB market should be considering.
In the EU, from 26 May 2021 the EU MDR applies, replacing the MDD. The IVDR will take effect (and replace the IVDD) on 26 May 2022. For ease of reference, we refer to the MDR and the IVDR as the Regulations.
In Great Britain, the UK MDR 2002 applies. The EU MDR and IVDR will not apply in GB and the government is likely to implement its own specific medical device legislation using the powers granted to the health secretary under the Medicines and Medical Devices Act 2021.
In previous articles we set out the pathways to approval for medical devices in the UK from 1 January 2021. In short, until 30 June 2023 there are two routes to the GB market for devices: CE marks or UKCA marks. Firstly, CE marked devices (either under the existing Directives or the new Regulations) may continue to be placed on the GB market. Secondly, devices will be able to be placed on the market if they bear a UK Conformity Assessment (UKCA) mark.
UKCA marks will be assessed by bodies designated by the MHRA as UK Approved Bodies. The MHRA has designated the three legacy UK Notified Bodies as UK Approved Bodies:
- BSI Assurance UK Ltd – for general medical devices, active implantable medical devices and in-vitro diagnostics medical devices.
- SGS United Kingdom Limited – for general medical devices and in-vitro diagnostics medical devices.
- UL International (UK) Ltd – for one category of in-vitro diagnostic medical device (a trisomy 21 test).
These three bodies were automatically designated as UK Approved Bodies under UK MDR 2002 as they were existing UK Notified Bodies designated under the old Directives. The MHRA intends to publish a list of UK Approved Bodies in a new UK database, equivalent to the EU’s NANDO database.
As of 26 May 2021, the MHRA confirmed to Bristows that it has not received any formal applications to become UK Approved Bodies for medical devices but they have had “significant expressions of interest”. While the MHRA is not able to share any information about prospective or received applications, the MHRA is considering what information the MHRA might be able to share in future.
As highlighted in previous articles, the low number of Notified Bodies in the EU has created a critical bottleneck. Companies have been met with severe delays seeking conformity assessments from Notified Bodies for CE marks under the Regulations. We are willing to go out on a limb and say that these three UK Approved Bodies will not be able to meet the UK demand for UKCA marks.
From 1 July 2023, it will be mandatory for devices to be affixed with a UKCA mark in order to be placed on the GB market in virtually all cases (unless the manufacturer relies on the unfettered access rote).
Next steps for companies
Companies who wish to commercialise devices in the GB should prepare as early as possible to ensure there is sufficient time for their chosen UK Approved Body to process their submissions and address any concerns.
Companies who hope that their existing EU Notified Body will be able to issue them with UKCA marks should ask those EU Notified Bodies when they plan to submit applications to the MHRA and when they expect to be appointed.
As we have seen over the last four years since the MDR and IVDR were adopted, kicking the can down the road can generate significant anxiety (and cost).