We have previously discussed the changes to the regulation of medical devices both in the UK and the European Union in our May 2020 blog post here. This post provides an update on the UK Medicines and Medical Devices Bill (the UK Bill), post-Brexit transition period guidance in the UK on the regulation of medical devices, and the impact of the upcoming EU Medical Devices Regulation and the EU in vitro Diagnostic Medical Devices Regulation (the EU Regulations).
Regulating medical devices in the UK from 1 January 2021 – Post-Brexit transition period guidance from the MHRA
The UK Government has now issued guidance “Regulating medical devices from 1 January 2021”on the regulation of medical devices in the UK , following the end of the Brexit transition period.
From 1 January 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) will take on the responsibility for the regulation of UK medical devices. The guidance applies to Great Britain (England, Wales and Scotland), but different rules will apply to Northern Ireland after the transition period.
There will be a number of changes to how medical devices are placed on the Great Britain market, for example:
- CE marking and certificates issued by EU-recognised Notified Bodies will continue to be recognised in Great Britain but only until 30 June 2023. A CE mark is a logo that is placed on medical devices to show they conform to the requirements in the relevant EU directives. A ‘Notified Body’ refers to an organisation that has been designated to assess whether manufacturers and their medical devices meet certain requirements and can receive the CE mark. There are currently over 50 EU Notified Bodies that can certify to the medical devices regulations – however, according to the current list, this only includes two that are based in the UK.
- From 1 January 2021, a new mark will be introduced in the UK – the UKCA (UK Conformity Assessed) – and it will be required on all devices placed on the Great Britain market from 1 July 2023.
- From 1 January 2021, the EU will no longer recognise UK Notified Bodies, and they will not be able to issue CE certificates. UK Notified Bodies will become ‘UK Approved Bodies’, and only these bodies will be able to conduct conformity assessments in relation to the UKCA mark.
- For manufacturers seeking to place a medical device on the Great Britain market from 1 January 2021, a new route to market and product marking will be available. This new route requires registration of all medical devices, including in vitro diagnostic medical devices (IVDs) and active implantable medical devices, by the MHRA. There will be a cascading grace period for registration of devices, depending on what class they fall under, ranging from registration by 1 May 2021 to 1 January 2022.
- All manufacturers of medical devices will first need to register with the MHRA. For manufacturers based outside the UK, a single UK Responsible Person will need to be appointed. This person will take responsibility for the product in the UK, rather than the manufacturer.
- Once a medical device has been placed on the UK market, the manufacturer will continue to be required to submit vigilance reports to the MHRA when certain incidents occur in the UK that involve their device, and must take appropriate safety action when required.
In relation to placing medical devices on the EU market for UK-based manufacturers, from 1 January 2021, these devices will still need to comply with the relevant EU legislation and be affixed with CE marking. The UKCA marking discussed above will not be recognised on the EU market – however, both CE and UKCA marking can be placed on the same product provided that each are clearly visible. Furthermore, after the end of the transition period, medical devices can only be placed on the EU market if they have been assessed by an EU-recognised Notified Body (although those placed on the EU market before 1 January 2021 can remain, even if they were assessed by a UK-based Notified Body).
The UK Bill
The UK Bill is still progressing through the parliamentary process. It is currently at the report stage before the House of Lords, which gives the MPs an opportunity to consider and discuss further amendments that have been proposed to the UK Bill. The next stage will be a third reading at the House of Lords, followed by the consideration of amendments by the House of Commons. Once the UK Bill is agreed, it will receive royal assent.
The UK Bill provides critical delegated powers to enable the regulatory regimes for human medicines, clinical trials of human medicines, veterinary medicines and medical devices to be updated. It also consolidates the enforcement regime for medical devices, and provides the Secretary of State with the ability to impose civil sanctions as an alternative to criminal prosecution.
Explanatory Notes for the UK Bill were released on 24 June 2020 and they can be accessed here. The notes, which are not endorsed by Parliament, provide some practical background to the UK Bill and its policy considerations. While the UK Bill will enable the regulatory regimes to be flexible and adaptive to new technologies and changes in practice, little guidance has been provided as to what changes will be implemented in the future. In relation to medical devices, the Explanatory Notes foreshadow that these may include the introduction of provisions such as:
- Only allowing the registration of manufacturers or authorised representatives that have a place of business in the UK and that are placing the lowest risk devices on the UK market (as discussed above);
- Specifying what information should be included on the label and / or packaging of a device, and what should be included in instructions for use that accompany the device;
- Requiring the recording of information in relation to the safety and efficacy of medical devices (including information as to whether or not devices comply with relevant requirements); and
- Permitting the relaxing of certain regulatory requirements in circumstances where there is a need to protect the public from a threat of serious harm to health, which would include, for example, the Covid-19 pandemic.
The EU Regulations
The EU Regulations comprise the EU regulation on Medical Devices (Regulation 2017/745) and the EU regulation on in vitro diagnostic medical devices (Regulation 2017/746). The EU Regulations will fully apply in EU Member States from 26 May 2021 (for the medical devices regulation) and 26 May 2022 (for the in vitro diagnostic medical devices regulation). As these regulations will not take effect until after the transition period, they will not automatically apply in Great Britain, and the provisions contained within the EU Regulations will not be transposed into law and will not be implemented in Great Britain.
The intention is that the UK Bill will set out the regime for the regulation of medical devices, rather than the EU Regulations. The UK Government has made it clear that it will take into consideration international standards and global harmonisation in the development of the future system, without necessarily being bound to adopt any particular foreign regulation.
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