How BREXIT affects the export of medical devices to the UK?
From 1 January 2021, the United Kingdom is out of the customs union ,the single market of the European Union and ceased to be bound by EU law. Until the last few days, it was unclear how the UK’s cooperation with the rest of the European Union would ultimately look. The Brexit deal creates regulatory barriers to trade in medical devices between the UK and the European Union.
In this article we provide a summary of the key requirements for the introduction of medical devices into the UK market (England, Wales and Scotland):
- The CE marking will be recognised by the UK until 30 June 2023. Therefore, certificates issued by Notified Bodies recognised by the EU will be valid until the end of that date.
- UK Notified Bodies are no longer qualified as EU Notified Bodies and are no longer able to issue CE certificates. From 1 January 2021 these bodies have become approved UK bodies.
- Different requirements apply in Northern Ireland compared to those in Great Britain (England, Wales and Scotland).
- From 1 January 2021, all medical devices and in vitro diagnostic medical devices to be placed on the UK market should be registered with the UK Competent Authority (MHRA), which is the equivalent of the Polish URPLWMiPB. Transitional periods have been introduced to this rule.
| Classification | Final date for registration in MHRA |
|---|---|
| Medical devices class III | 1 May 2021 |
| Implantable medical devices class IIb | |
| Active implantable medical devices | |
| In vitro diagnostic medical devices (IVD), list A | |
| Medical devices class IIa and IIb (not implantable) | 1 September 2021 |
| In vitro diagnostic medical devices, list B | |
| Self-Test in vitro diagnostic medical devices (IVDs) | |
| Medical devices class I | 1 January 2022 |
| Custom-made medical devices | |
| General IVDs (out of the list) |
Who can register medical devices in MHRA?
If you are a manufacturer from the territory outside the UK and want to place a medical device or in vitro diagnostic medical device on the Great Britain market, you are oblidged to appoint a UK Responsible Person (UKRP). The UK Responsible is the actor who will take all the responsibility for the product in the territory of Great Britain. The UK Responsible Person (UKRP) must have a registered place of business in the UK.
What are the key responsibilities of UK Responsible Person (UKRP)?
- ensure that the TD is available and updated in a timely manner,
- ensure the conformity assessment of the device has been concluded,
- ensure the preparation of the Declaration of Conformity (DoC),
- have all the information about the device and prepare the details and samples of the medical device requested by the MHRA. In case of non-availability of samples, the UKRP may coordinate with the manufacturer to ensure that the samples are presented.
What are the labelling requirements for medical devices in the UK?
Manufacturers must comply with the relevant product labelling and conformity assessment requirements for medical devices as well as in vitro diagnostic medical devices. Where applicable, the number of the Notified or Approved Body (UK Approved Body) must appear on the label.
If a device already has a valid CE marking, there is no obligation to re-label the device with the UKCA mark until 1 July 2023 in order to place it on the UK market. Products can have both markings present on the label before 1 July 2023 and the dual marking will continue to be accepted in the UK market after 1 July 2023. Where a product already has a valid CE marking, it is not required to re-label the product with the UKCA mark until 1 July 2023. However, the name and address of the responsible person in the UK, must be displayed on the UKCA-marked product label.