Standard

Implementation of the future regulations

Updated 11 December 2024

1. Implementation of the future regulations

The government intends to introduce new regulations for  medical devices that prioritise patient safety, give patients access to the medical devices they need and ensure the UK remains an attractive market for medical technology innovators.
The approach to this reform was outlined in the government response to the 2021 consultation on the future regulation of medical devices in the UK. The government will ensure that there is a proportionate, phased approach to the implementation of the future regulatory framework, which supports system readiness and minimises the risk of supply disruption for UK patients.

This guidance has been updated with a Roadmap towards the future regulatory framework for medical devices (published 9 January 2024) which sets out intended timescales for delivery of the future core regulations.

The regulations will be delivered through four Statutory Instruments. It is intended that priority measures to enhance post-market surveillance will be put in place first in 2024, with core elements of the new framework expected to be in place in 2025.

2. Transitional arrangements

The government has put in place legislation that amends The Medical Device Regulations 2002 (SI 2002 No 618, as amended) (UK MDR) to extend the acceptance of CE marked medical devices on the Great Britain market. This will support the ongoing safe supply of medical devices to Great Britain and ease the transition to the future regulatory framework for medical devices.

It has introduced legislation which provides that CE marked medical devices may be placed on the Great Britain market to the following timelines:

• general 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 marking can be placed on the Great Britain market up until the sooner of expiry of certificate or 30 June 2028
• in vitro diagnostic medical devices (IVDs) compliant with the EU in vitro diagnostic medical devices directive (EU IVDD) can be placed on the Great Britain market up until the sooner of expiry of certificate or 30 June 2030, and
• general medical devices, including custom-made 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 up until the 30 June 2030.

This will enable certain CE marked medical devices to continue to be placed on the Great Britain market for longer.

The legislation provides that you can place self-declared CE marked Class I medical devices on the GB market beyond 30 June 2023 if they are:

• self-declared against EU MDR requirements (until 30 June 2030), or
• self-declared against MDD requirements before 26 May 2021 where Notified Body involvement in their assessment is not required under MDD but is under EU MDR (until 30 June 2028). This includes upclassified devices and reusable surgical instruments.

It also provides that you can place a Class I medical device which has a sterile or measuring function with a valid MDD certificate on the GB market until 30 June 2028.

Class I medical devices and general IVDs under the Directives, for which the conformity assessment under the EU MDD or EU IVDD did not require a notified body, can only be placed on the Great Britain market if the involvement of a notified body would be required under the EU MDR or IVDR (i.e., if it is an upclassified device or a reusable surgical instrument Class I device). Custom-made devices that are compliant with the EU MDD or EU AIMDD can no longer be placed on the Great Britain market.

If placing medical devices on the Great Britain market under these transitional measures, manufacturers will not be able to rely on expired certificates (unless such certificates have been otherwise deemed valid by the EU).

You can download an infographic of the timelines for placement of CE marked medical devices on the Great Britain market under the Medical Devices (Amendment) (Great Britain) Regulations 2023

We are reviewing our position on acceptance of EU MDR and EU IVDR CE certificates renewed after a strengthened future regime for medical devices is in place, taking on board stakeholder feedback. We will publish an update on this in due course. Please note that existing legislation does not prevent reliance on renewed EU MDR and EU IVDR certificates for placing medical devices on the GB market until 30 June 2030.

3. Post-Market Surveillance requirements

Further to the consultation on the future regulation of medical devices in the UK, the government also intends to introduce legislation in 2024 that will bring into force strengthened Post-Market Surveillance requirements (PMS) in Great Britain ahead of the wider future regulatory regime. This reflects the government’s priority of improving patient safety as part of the future medical device regulations.

The draft Post-Market Surveillance statutory instrument (PMS SI) was laid in Parliament on 21 October 2024.This instrument will introduce new PMS requirements for medical devices that prioritise patient safety, while still giving patients access to the safe medical devices they need and ensuring the UK remains an attractive market for medical technology innovators.  

A draft of the PMS SI was published on the World Trade Organization (WTO) website on 26 July 2023. The WTO notice included a link to the draft PMS SI, providing interested stakeholders with early notice of the intended legislative changes. The MHRA have given the response to that review careful consideration and amended the draft PMS SI accordingly in several areas to improve clarity and support manufacturers to understand their obligations. For further information on these changes please refer to the detailed response to WTO members.

The key changes within the final draft PMS SI include:

• Detail on what must be included as part of a PMS system, including the methods for collecting PMS data to support improved capturing of PMS data and harmonisation across manufacturers.
• Enhanced serious incident reporting obligations for manufacturers to support the detection of safety issues sooner.
• Clearer obligations on manufacturers to consider conducting a Field Safety Corrective Action (FSCA) to prevent or reduce the risk of a further serious incident. Accompanied by detailed requirements relating to Field Safety Notices (FSN) to better target patients and users at risk.
• More stringent requirements for manufacturers to conduct periodic reviews of their PMS data, including for implantable medical devices. This aims to support manufacturers in earlier detection of trends/signals that may have an impact on the safety of a medical device.

The draft PMS SI will be debated in Parliament and is expected to come into force in the Summer of 2025 following a 6-month implementation period. A full impact assessment and equalities impact assessment has been prepared for these regulations.

Comprehensive guidance will be published before the PMS SI comes into force to support manufacturers to understand their obligations and facilitate smooth implementation of these regulations.

4. Future core regulations

During the first half of 2024 we ran stakeholder discussions on the future core regulations to give early sight of the detailed policy, developed from the policy positions in the consultation response.

We also held a webinar which covered the intentions regarding scope, classification of general medical devices and IVDs, essential requirements and information to be provided with medical devices. See MHRA MedTech Regulatory Reform Webinar - 5 March 2024.

On 14 November 2024, we published our Consultation on Medical Devices Regulations: Routes to market and in vitro diagnostic devices. The consultation will close on 5 January 2025 and the results will inform the regulatory updates, which will introduce additional measures that must be taken before a device can be put on the market

These ‘pre-market’ regulations will:

• Introduce several improvements for implantable medical devices; up-classifying them which will result in more stringent requirements and requiring manufacturers to provide implant cards to enable patients to know which device they have had implanted.
• Ensure devices have a unique device identifier (UDI).
• Change the classification of several types of devices, specifically increasing the class of certain software as a medical device and aligning IVD classifications with those of the International Medical Device Regulators Forum.
• Strengthen the requirements for technical documentation.
• Introduce a framework for international recognition, enabling swifter access for devices already approved by comparable regulators as well as for those who have Medical Device Single Audit Program (MDSAP) certificates.
• Include new requirements for custom-made devices.
• Include new requirements for the claims manufacturers can make about their medical devices requiring them to align with their statement of intended purpose.
• Bring the essential requirements for medical devices being placed on the market in GB into greater alignment with those of the EU. This will include cybersecurity requirements for software as a medical device including for artificial intelligence.

The ‘pre-market regulations will enable greater international collaboration and practices, with more patient-centred, proportionate requirements for medical devices which are responsive to technological advances.

5. Updates to guidance

We are working with industry, Trade Associations and the wider medical devices community to support the effective implementation of the new regulations. The regulatory changes will be accompanied by guidance to support the MedTech sector in the interpretation of the new regulatory requirements.