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Preparing for UKCA Certification?

Essential Steps for Medical Device Manufacturers and Distributors
27 Dec 2022

There are approximately 600,000 medical devices available on the UK market1. From 1 July 2024, medical devices sold in the UK market must bear the UKCA mark to indicate that they conform with UK regulations. Devices will not be permitted to be sold in the UK market if the UK Conformity Assessed (UKCA) mark is not obtained by July 1, 2024, and the CE mark alone will not be recognized.

It’s time to act before it is too late!

Here is a glimpse of what exactly is UKCA mark, who should apply, the transition period and timelines, the benefits of obtaining a UKCA mark, and our offerings.

What is the UKCA mark for medical devices?

The UKCA mark is a new product conformity marking that will be mandatory for the products that are presently covered under regulations and directives for CE marking, to get market access in Great Britain i.e., England, Wales, and Scotland (excluding Northern Ireland). UKCA mark refers to the manufacturer’s declaration that the product fulfils all the required regulations and standards, which include safety, health, and environmental protection requirements.

From January 2021, all medical devices are mandated to be registered with MHRA and transition of the existing CE marking to UKCA mark by July 2024.

After Brexit and the withdrawal of the United Kingdom from the European Union on 31st January 2020, the UK set its own trade policies. The UKCA mark is one of the results of the new trade policies and was introduced on 01 January 2021. Medical device manufacturers can use the UKCA mark for medical devices from 01 January 2021. However, medical devices with EU CE marking will be recognized and can be marketed in the UK till 01 July 2024.

Medical devices including in vitro diagnostic medical devices (IVDs), custom-made devices, and systems or procedure packs must be registered with the Medicines and Healthcare Products Regulatory Agency (MHRA) from 01 January 2021, whether CE marked or UKCA marked, before being placed on the Great Britain market. The MHRA has stated that the UKCA mark "will provide continued assurance to patients and clinicians that the medical devices they use are safe and fit for purpose". MHRA, which is responsible for regulating the UK medical devices market, is associated with implementing vigilance, sampling, reporting activities, managing incidents, and surveillance of medical devices in the UK market. If the legal manufacturer of the medical devices is based outside the UK, a UK Responsible Person (UKRP) must be appointed, who will act on behalf of the manufacturer to carry out specified tasks, such as registration, and ensure that the declaration of conformity and technical documentation is up-to-date.

The UKCA mark will have three conformity assessment routes, depending on the class of medical device:

1.
Self-declaration by the manufacturer
2.
Notified body certification
3.
Clinical evaluation by an authorized person

Gain trust with your customers by reiterating that you meet the highest standards associated with the UKCA mark

As a medical device manufacturer in the United Kingdom, it is mandatory to obtain a UK Conformity Assessed(UKCA) mark for your products. Obtaining the UKCA marking for your devices indicates that your devices have met the highest standards and are accessible to be marketed in UK region.

Obtaining a UKCA mark is a systematic process, but it is well worth it in the end.

The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating the UK medical devices market.

  • Manufacturers who aim at placing their medical devices in the Great Britain market should initially register with MHRA​

    If the manufacturer is not established in the UK, a UKRP should be appointed by the manufacturer to register with MHRA and to act on their behalf​

    In Great Britain, medical devices must conform to the UK MDR 2002, the EU MDR, or the EU IVDR in order to be registered with the MHRA ​

    Medical devices with a CE mark obtained under the EU MDD, EU AIMDD or EU IVDD regulations will be accepted in the Great Britain market until 01 July 2024, provided their certificates remain valid for the EU market under the transitional arrangements in the EU MDR and EU IVD

Key points to be noted by the manufacturers in order to use the UKCA mark include:

1.
Determine if the UKCA mark is required: The UKCA mark is only required for products that are placed on the market in England, Scotland, or Wales
2.
Check if the product requires approval: Some products, such as those that are subject to safety standards or medical devices, will require approval from an authorized body before the UKCA mark can be used
3.
Identify the relevant standards: Products must comply with any relevant British or European standards in order to use the UKCA mark
4.
Apply the UKCA mark: Once the above key points are verified and the required documents are in place, manufacturers can apply the UKCA mark to their products​

Technical documentation plays a key role in the smooth flow of the process. Record keeping by the manufacturers is a must, which refers to the document that demonstrates that your product is in line with the regulatory requirements. This record-keeping in general includes details on product design, manufacturing, address of the manufacturer, any storage facilities, and many other relevant documents.

Labeling of your product:

It is mandated that the medical devices placed on the Great Britain Market must have a UKCA mark from 01 July 2024. However, if the device has a valid CE marking, then re-labeling with the UKCA mark is not required until 01 July 2024 for placement on the Great Britain market. During the transition period, these devices can have both the CE and UKCA mark on the labeling, and dual marking will be accepted on the Great Britain market after 01 July 2024. Additionally, the name and address of the UKRP where applicable should be included on product labeling or the outer packaging, or the instructions for use in the scenario where the UKCA mark has been affixed and the legal manufacturer is outside the UK.

Why Indegene?

We provide comprehensive quality and regulatory services for global medical device manufacturers. Our team of experienced professionals who have supported in over 150 products and 10+ IVDs is here to help you navigate the complex regulatory landscape with ease, ensuring that your medical device meets all necessary safety and performance standards thereby aiding in an early and successful market launch.

If you are transitioning from CE mark to UKCA mark, our team of experts can support you with the gap assessment and compilation of clinical and technical documentation/declaration of conformity required to ensure safety and performance of your medical device.

For more information on the UKCA mark and the conformity assessment routes talk to us.

References

1.
https://www.gov.uk/government/publications/medicines-and-medical-devices-bill-overarching-documents/factsheet-medical-devices-overview

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