Mindset XR Module 1: How is immersive technology for mental health regulated in the UK and EU?

UKCA marking symbol

In order to place a medical device on the market in the UK, you must meet the requirements of the regulations for that device. After this, you are awarded a certificate of conformity and the right to place that UKCA marking symbol on your device. Please note, different rules apply in Northern Ireland due to the Protocol on Ireland/Northern Ireland.

Following the Medicines and Medical Devices Act of February 2021, the UK regulatory infrastructure is covered under the following legislation:

1. The Medical Device Regulations (MDR) 2002

The MDR 2002 are the current regulations in the UK. These were amended from the EU medical device directives, which were enforced across the EU before 2021.

2. Data Protection Act 2018 (UK GDPR)

Data protection in the UK is governed by the UK GDPR, which is very similar to GDPR legislation in the EU. 

The EU regulatory infrastructure is made up of four key legalisations:

1. EU Medical Device Regulations (EU MDR) 

The new EU MDR formally came into force in 2017, with a transition period up to 2021.

2. EU GDPR regulations

Data protection is covered under the EU GDPR regulations, which came into force in 2018.

3. CE marking symbol

When you have been deemed to meet the requirements of the EU MDR, you are awarded a certificate of conformity and the right to use the CE marking symbol on your device.

4. EU Artificial Intelligence (AI) Act

The EU AI Act is a new legislation formally adopted by the European Council in May 2024, with the final act due to be published in the summer of 2024. This will come into force 20 days after publication. Specific sections of the act will be introduced as part of transitional arrangements over the following 36 months, though it is good practice to be prepared for compliance sooner. This act applies to a range of devices involving artificial intelligence, not only medical devices. It categorises devices by risk of harm on the following scale:

• 
  

  Unacceptable

• 
  

  High

• 
  

  Limited

• 
  

  Minimal

Please note: products and medical devices deemed unacceptable are banned.

The UK regulatory authorities include the following connected bodies:

UKCA > National Governance > Approved Bodies > Vendors

Let’s explore each in body more detail:

UKCA

Having a valid UKCA mark on your product demonstrates that you have met the requirements of The Medical Device Regulations (MDR) 2002. This allows you to place your device on the market in the UK.

National Governance

The Medicines and Healthcare Products Regulatory Agency (MHRA) is responsible for regulating the UK medical devices market. The MHRA also performs market surveillance of medical devices on the UK market and is able to take decisions over the marketing and supply of devices in the UK.

Approved Bodies 

Medical devices are classified by risk (find out more in module 3). Moderate and high risk devices are required to undergo a conformity assessment by a UK approved body. The MHRA is responsible for the designation and monitoring of UK approved bodies. Medical device manufacturers are responsible for engaging an appropriate approved body who will assess their medical device file documentation and issue a certificate of conformity. Once UKCA marking has been achieved, manufacturers are required to register on the MHRA Public Access Registration Database (PARD).

Expected changes to UK regulation

Following Brexit, the UK government announced that CE marked devices will continue to be accepted on the UK market until at least 2028. The UK government also recently announced proposed plans to allow international recognition of certification from certain comparable countries and regions. These include the EU, Australia, Canada and the USA. Notably the premarket 510 (k) process, from the the Food, Drug, and Cosmetic Act, was not included. It is expected that UK medical device regulations will become more in line with the EU Medical Device Regulations (MDR) by 2025.

The EU regulatory authorities include the following connected bodies:

EU Governance > National Governance > Notified Bodies > Vendors

Let’s explore each body in more detail:

EU Governance

The EU Medical Device Regulations (MDR) covers all EU member states. Any manufacturer wishing to place a medical device on the EU market must comply with these regulations. 

National Governance

Each EU member state has its own competent authority in charge of market surveillance and responsible for designation and monitoring of notified bodies.

Notified Bodies

Notified bodies are the EU equivalent to approved bodies in the UK. Competent authorities are often the Ministry of Health of the EU member state. For example, the competent authority of the Netherlands is the Ministry of Health, Welfare and Sport.

A notified body is an independent third party organisation approved by the competent authority to determine if a system or product meets applicable requirements and has the power to issue conformity certificates for CE marking. There is currently a well recognised backlog within both notified bodies and approved bodies. This often results in a 12 to 18 month delay in undergoing a conformity assessment.