The Post-Brexit era
At the end of the Brexit transition period, the UK Medical Devices Regulations 2002 (UK MDR) were amended to create the UK’s own UK Conformity Assessed (UKCA) regulatory framework for medical devices from 1 January 2021. The UK MDR were also amended at that time so that CE markings (the EU certification standard) would still be accepted for medical devices in Great Britain until 30 June 2023. This so-called “standstill period” was provided to allow time to transition to the UKCA regime for medical devices, giving manufacturers the choice to either comply with the UKCA regime or with the CE regime.
The extension to the standstill
The standstill period is being extended today to 30 June 2028 or 30 June 2030, depending on the type of device in question:
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medical devices that comply with the EU Medical Devices Directive (EU MDD) or EU Active Implantable Medical Devices Directive (EU AIMDD) and which have a valid declaration and CE mark can be placed on the Great Britain market until 30 June 2028;
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IVDs that comply with the EU IVD Directive can be placed on the Great Britain market until 30 June 2030 (or the expiry of the certificate, if earlier);
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medical devices that comply with the EU MDR and IVDs that comply with the EU IVDR can be placed on the Great Britain market until 30 June 2030 (or the expiry of the certificate, if earlier).
The underlying reasons for these extensions are partly due to the complexity of creating a new domestic regulatory regime, which have been compounded by the need to ensure there are an adequate number of Approved Bodies in existence, in order to issue UKCA markings.
The consequence of this is that manufacturers will, as the legislation currently stands, have a much longer period in which certain medical devices that comply with the EU medical devices and IVD legislation can be placed on the market in Great Britain. The UKCA route to market continues to exist as an alternative.
Interestingly, the standstill period is not extended for all custom-made devices - compliance with the EU MDD or the EU AIMDD no longer confers an ability to place such devices on the Great Britain market. Similarly, the standstill period is also not extended in relation to devices that are provided for clinical investigations and performance evaluations.
Next Steps
Enshrining the status quo in legislation for several more years provides a degree of stability for industry as regards how CE-marked medical devices are to be treated in Great Britain.
However, the timeline for the domestic reform programme is still not clear cut. We expect the post-market surveillance reforms to be introduced at some point this year with a commencement date in the summer of 2024. We will provide further similar updates to this, as the picture becomes clearer.
In the meantime, the Medicines and Healthcare products Regulatory Agency (MHRA) are continuing with a programme of guidance aimed at filling some of the space in this area until such time as the legislative reform takes effect. For example, in April this year, MHRA produced guidance setting out its approach to software and artificial intelligence as a medical device (SaMD and AIaMD). Although this does not have the force of law, it is helpful in setting out how the MHRA, as the regulator, approaches the topic. For example it provides examples of software that the MHRA considers meet the definition of a medical device and therefore require a UKCA marking.
If you require advice on the current legislative requirements, or the guidance being issued by the MHRA, in relation to your organisation’s specific product(s), please contact the authors, or the Hogan Lovells attorneys with whom you regularly work.
Authored by Jane Summerfield and Owen Robinson.
