MHRA Deadlines 2023
UK Responsible Person for MHRA Registration of Medical Devices
June 20th 2023 marks an important milestone in the legislation that extends the standstill period for EU CE-marked medical devices in Great Britain (England, Wales, and Scotland). This legislation ensures that these devices can continue to be placed on the market while the UK transitions to its own regulatory framework for medical devices, known as the UK Conformity Assessed (UKCA) regime.
At the end of the Brexit transition period, the UK Medical Devices Regulations 2002 (UK MDR) were amended to establish the UKCA framework, effective from January 1, 2021. During this transition, CE markings, which represent EU certification standards, were still accepted for medical devices in Great Britain until June 30, 2023. This standstill period allowed manufacturers the option to comply either with the UKCA regime or the CE regime.
Today, the standstill period is being extended to either June 30, 2028, or June 30, 2030, depending on the type of device.
New MHRA timeline:
1. Medical devices compliant with the EU Medical Devices Directive (EU MDD) or EU Active Implantable Medical Devices Directive (EU AIMDD), with a valid declaration and CE mark, can be placed on the Great Britain market until June 30, 2028.
2. In vitro diagnostic medical devices (IVDs) compliant with the EU IVD Directive can be placed on the Great Britain market until June 30, 2030, or until the expiration of the certificate, if earlier.
3. Medical devices compliant with the EU Medical Devices Regulation (EU MDR) and IVDs compliant with the EU In Vitro Diagnostic Medical Devices Regulation (EU IVDR) can be placed on the Great Britain market until June 30, 2030, or until the expiration of the certificate, if earlier.
The extension of the standstill period is necessary due to the complexity of creating a new domestic regulatory regime, compounded by the need to ensure an adequate number of Approved Bodies are available to issue UKCA markings. As a result, manufacturers will have a significantly longer period to place certain medical devices that comply with EU regulations on the market in Great Britain. The UKCA route to market remains an alternative option.
It is worth noting that the standstill period is not extended for all custom-made devices, and compliance with the EU MDD or EU AIMDD no longer allows such devices to be placed on the market in Great Britain. The standstill period also does not apply to devices used for clinical investigations and performance evaluations.
By enshrining the status quo in legislation for several more years, the industry gains stability and clarity on how CE-marked medical devices will be treated in Great Britain. However, the timeline for the domestic reform program is still unclear. Reforms related to post-market surveillance are expected to be introduced sometime this year, with a commencement date in the summer of 2024. Further updates will be provided as the situation becomes clearer.
In the meantime, the Medicines and Healthcare products Regulatory Agency (MHRA) continues to release guidance to address the regulatory gaps until the legislative reforms take effect. For instance, in April of this year, the MHRA published guidance on software and artificial intelligence as medical devices (SaMD and AIaMD). While not legally binding, this guidance outlines the MHRA's approach to these topics and provides examples of software that require a UKCA marking as they meet the definition of a medical device.
AF Pharma offers comprehensive services as a UK Responsible Person (UKRP) for medical devices, providing manufacturers with the expertise and support necessary for successful MHRA registration. As a trusted partner, AF Pharma can guide manufacturers through the registration process, ensuring compliance with UK regulations and facilitating the placement of medical devices on the Great Britain market. With our in-depth knowledge of the regulatory landscape and our commitment to excellence, we are equipped to assist manufacturers in navigating the complexities of MHRA registration, streamlining the pathway to market access for their medical devices.