An MHRA statement of policy intent is designed to recognise approvals from specific foreign territories and to simplify and speed-up the regulatory process for medical devices. Thorrun Govind, solicitor (Brabners LLP), pharmacist and TV health expert, explains what this means.

Framework for medical device approvals

Under the new MHRA proposed framework for international recognition of medical devices, the government has indicated that it intends to recognise the regulatory decisions and approvals of four comparable regulator countries (CRCs) — namely Australia (Therapeutic Goods Administration), Canada (Health Canada), the European Union (National competent authorities in the member states of the EU/European Economic Area) and the US (Food and Drug Administration).

While the MHRA’s proposal currently refers to four CRCs, there seems to be scope for other countries and jurisdictions to be considered under this framework in future. The MHRA is reportedly considering recognising additional medical device approvals from Japan.

What does this mean for pharmacy?

For those operating in multiple jurisdictions, the proposed framework offers the opportunity for a more streamlined process for medical device approvals. It allows compliance with one primary regulatory regime to place products on multiple markets.

This framework should encourage innovation and support manufacturers in the CRCs to place products on the market — rather than being put off by regulatory hoops. If all goes to plan this will support a greater range of devices being available in the pharmacy and more variety for patients. This might also make pricing more competitive.

Under a new proposal, the UK Government intends to allow certain medical devices that have been approved by international regulators to be placed on the GB market without obtaining a UKCA (UK Conformity Assessed) marking or UKCA certification.

Eligibility

For medical devices to qualify under the proposed framework they must comply with the relevant legislation in the CRC and reflect the device that is authorised in the CRC with regard to all aspects such as the design, intended purpose and manufacturing process.

The label and packaging should include English language, with the label also including the name and address of the UK responsible person in addition to a physical unique identifier in accordance with the UK Medical Devices Regulations or CRC.

The medical device must comply with GB requirements for electronics compatibility, units of measurement and labelling and comply with the new post-market surveillance (PMS) requirements in the UK Medical Devices Regulations (once they’re in force).

Some medical devices listed in the proposal aren’t to be recognised, such as exempted in-house devices, custom-made devices or products granted market access in the CRC via a recognition route.

Four access routes are detailed in the proposed framework:

  1. Recognition, self-registration with MHRA.
  2. Reliance.
  3. Reliance with device-specific requirements.
  4. Reliance with abridged assessment and device-specific requirements.

Since each access route applies to different medical devices, it’s important for manufacturers to carefully consider the UK Medical Devices Regulations to establish which classification applies for their device and which access route is appropriate.

The manufacturer will be required to prepare documentation and materials, which may vary depending on which access route is followed — as will the requirements for submitting documentation. For example, self-registration with MHRA access route will require the manufacturer to prepare a declaration to an appropriate quality management system or product-specific equivalent. Alternatively, the reliance access route requires the manufacturer to submit a dossier in the International Medical Device Regulators Forum in addition to evidence of approval, a PMS plan and a PMS report or periodic safety update report.

International recognition

According to the proposed framework, a certificate of international recognition will be issued that allows medical devices to gain access to the GB market once a manufacturer has successfully complied with the relevant requirements.

This will be separate to a UKCA marking or UKCA certification, which will still be available to manufacturers that wish to access the GB market without using international recognition.

It’s important to note that market access will be granted in accordance with the validity of the certificate issued by the CRC. The medical device must be re-certified when the original certificate provided by the CRC expires or in accordance with the quality management system where the CRC — such as the USA — allows indefinite market access.

Dr Laura Squire, chief quality and access officer at the MHRA, highlighted how the MHRA’s proposal aims to benefit patients by using the knowledge, expertise and approvals of other regulatory bodies. She recognises announcement as ‘an important step forward towards a robust MedTech regulatory framework that prioritises patient safety, gives patients access to the medical devices they need and ensures the UK remains an attractive market for medical technology innovators’.

Many questions

The proposed framework lacks full detail and raises several key questions. For example, are the selected CRCs correct? What was the rationale for choosing them? How will certification work in the devolved nations?

The MHRA will also need to consider where the technical dossier will be held and how things will work if it’s only to be reviewed when things go wrong, as well as how post-marketing surveillance will fit in.

We also await information as to which bodies can issue the certificate of international recognition and whether they have enough capacity to do this. It is also likely that it will be a good few weeks before we receive any further updates from the MHRA as the new government settles in.