Stethoscope on the Cardiogram

UKCA MARKING

and

UK RESPONSIBLE PERSON 

Requirements

New rules for January 2021

​From 1 January 2021 the Medicines and Healthcare products Regulatory Agency (MHRA) will take on the responsibilities for the UK medical devices market that are currently undertaken through the EU system. Detailed guidance can be found on the UK government website.

When the UK leaves the European Union on 31 December 2020 medical devices placed on the UK market will be required to use the new UK product marking, the UKCA (UK Conformity Assessed) mark. Furthermore, all manufacturers based outside of the UK will require a “responsible person“ based in the UK. Psephos can assist you with both your UKCA marking and/or fulfilling your responsible person role - contact us today.

What is UKCA?

 

The UKCA (UK Conformity Assessed) marking is a new UK product marking that will be used for goods being placed on the market in Great Britain (England, Wales and Scotland). It covers most goods which previously required the CE marking.

Medical devices being placed on the Northern Ireland market have different requirements. Please speak to us should you have that requirement.

What are the key requirements?

 

From 1 January 2021, there will be a number of changes to how medical devices are placed on the market in Great Britain. These are:

  • CE marking will continue to be used and recognised until 30 June 2023

  • Certificates issued by European Economic Area (EEA)-based Notified Bodies will continue to be valid for the Great Britain market until 30 June 2023

  • A new route to market and product marking will be available for manufacturers wishing to place a device on the Great Britain market from 1 January 2021

  • From 1 January 2021, all medical devices and in vitro diagnostic medical devices (IVDs) placed on the UK market will need to be registered with the MHRA. There will be a grace period for registering:

    • 4 months for Class IIIs and Class IIb implantables, and all active implantable medical devices

    • 8 months for other Class IIb and all Class IIa devices

    • 12 months for Class I devices

  • If you are a manufacturer based outside the UK and wish to place a device on the UK market, you will need to establish a UK Responsible Person who will take responsibility for the product in the UK. Psephos can assist you with fulfilling your responsible person role - contact us today.

 

Responsible person role

 

To place a device on the Great Britain market, manufacturers based outside the UK will need to designate a UK Responsible Person that is established in the UK.

The UK Responsible Person will act on behalf of the outside-UK manufacturer to carry out specified tasks in relation to the manufacturer’s obligations. This includes registering with the MHRA before the manufacturer’s devices can be placed on the UK market.

The responsibilities of the UK Responsible Person will be set out in the UK MDR 2002 (in the form in which they exist on 1 January 2021). In summary, the UK Responsible Person must:

  • Ensure that the declaration of conformity and technical documentation have been drawn up and an appropriate conformity assessment procedure has been carried out by the manufacturer.

  • Keep available a copy of the technical documentation, a copy of the declaration of conformity and copies of relevant certificates

  • Provide the MHRA with all the information and documentation requested

  • Forward to the manufacturer any request by the MHRA for samples, or access to a device, and ensure that the MHRA receives the samples or has been given access to the device.

  • Cooperate with the MHRA on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices.

  • Immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated.

  • Terminate the legal relationship with the manufacturer if the manufacturer acts contrary to its obligations under these Regulations and inform the MHRA and, if applicable, the relevant notified body of that termination.

How Psephos Biomedica can help?

 

At Psephos, our team of experienced consultants can guide you through the steps to gaining UK conformity and fulfilling your UK Responsible Person role. Contact us today to discuss further.

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