Skip to content
tVNS UK

Regulatory information

Regulatory status of the tVNS device in the UK, manufacturer information, UK Responsible Person, and how to report an adverse event.

Regulatory information

What this page is for

This page summarises the regulatory status of the tVNS device in the United Kingdom, identifies the manufacturer and the UK Responsible Person, and explains how to report an adverse event. It is written for patients, carers, clinicians, and anyone who wants to verify the regulatory basis on which the device is sold in the UK.

If you need more detail than this page provides, the contact page has our details.

The device

  • Device name: tVNS (transcutaneous vagus nerve stimulator)
  • Device class: Class IIa medical device
  • Indications: Epilepsy, depression, chronic migraine, and Prader-Willi syndrome (as stated by the manufacturer in the Instructions for Use)
  • Intended use: Adjunctive neuromodulation for adults aged 18 and over, used alongside standard care and under medical supervision, not as a replacement for existing treatment

Manufacturer

The tVNS device is manufactured by be-on-market GmbH (Lilienstr. 33, 91244 Reichenschwand, Germany). tVNS Technologies GmbH is the brand owner. The manufacturer holds the technical file, the quality management system certification, and the EU MDR conformity assessment for the device.

Regulatory status in Great Britain

The tVNS device is CE marked under EU Medical Device Regulation 2017/745 and is placed on the Great Britain market under the UK's transitional arrangements for medical devices.

Under those transitional arrangements, devices carrying a valid CE mark under EU MDR 2017/745 may be placed on the Great Britain market during the current transition period published by the MHRA. The MHRA has extended this transition on more than one occasion. For the current end date and any updates, the authoritative source is the MHRA at gov.uk/guidance/regulating-medical-devices-in-the-uk.

The device is registered with the MHRA for placement on the GB market. A UKCA transition will be completed in line with the manufacturer's regulatory roadmap and the applicable MHRA deadlines.

Northern Ireland

The tVNS device is CE marked under EU MDR 2017/745 and can be placed on the Northern Ireland market under the Windsor Framework.

UK Responsible Person

Under the UK Medical Devices Regulations 2002 (as amended), any non-UK manufacturer placing a medical device on the Great Britain market must appoint a UK Responsible Person (UKRP) registered with the MHRA.

Anatomical Concepts UK Ltd is the appointed UK Responsible Person for the tVNS device. That means that for regulatory purposes in Great Britain, you contact us. We act as the point of contact between the manufacturer in Germany and the MHRA, we handle regulatory correspondence and post-market surveillance obligations, and we are the first port of call if a serious incident or safety concern needs to be reported.

  • UKRP: Anatomical Concepts UK Ltd
  • MHRA registration reference: 0000038976
  • Registered address: Unit 18, Block 6, Trading Estate, Third Road, Blantyre, G72 0UP, Scotland, United Kingdom
  • Contact: support@anatomicalconcepts.com, +44 141 628 8222

Reporting an adverse event

If you or your patient has experienced an adverse event while using the tVNS device, we want to know.

  1. Contact us at Anatomical Concepts UK. Email support@anatomicalconcepts.com or call +44 141 628 8222. Include the device serial number, the date of the event, and a short description of what happened.
  2. We will submit a report to the MHRA Yellow Card scheme where appropriate, and work with the manufacturer on any corrective or preventive action.
  3. You can also report directly to the MHRA yourself at yellowcard.mhra.gov.uk. Patients, carers, and clinicians can all report Yellow Card events directly.

Serious incidents must be reported. If you are not sure whether something counts as an adverse event, please contact us and we will help you decide.

Further information

For general information about the UK regulatory framework for medical devices, the MHRA website is the authoritative source: gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency.

For questions about how this regulatory status applies to you or your patient, please contact us.

Contact Anatomical Concepts UK

tVNS is a Class IIa medical device manufactured by be-on-market GmbH, Germany, under the tVNS Technologies brand. Distributed in the UK by Anatomical Concepts UK Ltd.