UK government responds to medical devices consultation with new plans to strengthen the regulation of medical devices

The UK government has responded to the medical devices consultation (the original consultation is half way down the page) held between September and November 2021, with new plans to strengthen the regulation of medical devices in the UK.

Following the UKs exit from the European Union (EU), it has a unique opportunity to improve how medical devices and in vitro diagnostic medical devices (IVDs) are regulated in the United
Kingdom (UK). Powers in the Medicines and Medical Devices Act (2021) allow the UK to amend the Medical Devices Regulations 2002 which currently regulate medical devices in the UK, except in Northern Ireland which largely follows the EU medical devices regulatory system.

The new UK medical device regulatory framework will be built on the following five pillars:

  • Strengthening MHRA power to act to keep patients safe
  • Making the UK a focus for innovation, the best place to develop and introduce innovative medical devices
  • Addressing health inequalities and mitigating biases throughout medical device product lifecycles
  • Proportionate regulation which supports businesses through access routes that build on synergies with both EU and wider global standards
  • Setting world leading standards – Building the UKCA mark as a global exemplar

The response document is a hefty 155 pages. It is divided into 16 chapters. Generally, within each chapter, there are the following three sub-sections:

  • Proposals as put forward in the original consultation
  • Feedback and analysis from the consultation
  • Government response – This sets out how the MHRA proposes to move forward

For anyone not wishing to read the entire response document, there is the scope to read the response to each individual section here.

Below is a very limited and inexhaustive snapshot of the government responses.

Products without an intended medical purpose
  • It remains the government’s intention to proceed with the proposal to expand the scope of the UK medical devices regulations to include the list of product types outlined in a-g of section 2.3 of the consultation text. It is not intended to expand the scope to diagnostic tests without a medical purpose at this time but we will keep this under consideration.
  • In addition, in light of the positive consultation response, the government intends to require manufacturers of the products covered by this section will register them with the MHRA.
Essential requirements for medical devices

A significant number of responses to the consultation requested close alignment with the GSPRs set out in the EU MDR and IVDR, to avoid confusion and potentially duplicative or divergent requirements and to facilitate the ongoing supply of devices to the UK market. In light of this, the MHRA intends to broadly reflect the GSPRs in the UK regulations, tailored to the domestic context.

Manufacturer obligations – measures for recompense

The government intends to introduce a requirement for manufacturers to have measures in place (for example, sufficient financial coverage) for providing recompense to those impacted by adverse incidents with medical devices on the UK market.

Quality Management Systems (QMS)
  • The intention remains to proceed with the proposal to introduce the detailed requirements for QMS that address the aspects outlined in the consultation. In addition, the government recognises that there is a desire to have QMS requirements that are proportionate to the risk class of the medical device.
  • The government intends to require all medical device manufacturers, including manufacturers of Class I devices, custom-made devices and general in vitro diagnostic medical devices (IVDs) to apply an appropriate QMS. This requirement will also apply to health institutions.
UK Responsible Persons
  • The government intends to proceed with the proposal to clarify that the UKRP is legally liable (responsible or answerable in law) for defective medical devices on the same basis as the manufacturer, subject to further consideration on how this would operate in practice.
  • it remains the government’s intention to proceed with the proposal to include in the UK medical devices regulations:
    • a requirement for manufacturers and UKRPs to draw up a legal contract, subject to further consideration on how this would operate in practice.
    • a requirement for manufacturers to draw up a changeover agreement when changing their UKRP subject to further consideration on how this would operate in practice.
Obligations of importers and distributors

The government intends to:

  • adjust its position and to clarify in the regulations that fulfilment service providers (FSPs) will fall within the scope of the definitions and need to meet the requirements of ‘importers’ or ‘distributors’ depending on their role in the supply chain. It is considered that this approach will help mitigate the risks of duplication, while improving device traceability, supporting compliance activity and ensuring the safe supply of medical devices to the UK market.
  • proceed with the proposal to require economic operators to inform the MHRA if they are aware of any issues that will interrupt supply or cause a shortage of medical devices on the UK market.
Identification within the supply chain

The government intends to bring in requirements for distributors and importers to cooperate with manufacturers, UKRPs, and public and private sector healthcare professionals and institutions, to achieve an appropriate level of traceability for medical devices.

It also intends to bring in requirements for economic operators to identify and record the following information:

  1. any economic operator to whom they have directly supplied a medical device
  2. any economic operator who has directly supplied them with a medical device
  3. any public or private sector health institution or healthcare professional to which they have directly supplied a medical device

The government considers these traceability requirements are important and should apply regardless of medical device type.

Source: MHRA