UKCA certification refers to the certification standards that need to be met when selling medical devices in the UK market. According to British regulations, starting from January 1, 2023, medical devices sold to the UK must comply with UKCA certification requirements, replacing the previous CE certification. Obtaining UKCA certification requires compliance with the regulations and standards of the British government and relevant agencies, and the corresponding application and review process.
What is UK Conformity Assessment (UKCA) certification?
UKCA certification is a compliance procedure for medical devices to gain market access in the United Kingdom (UK). In the UK, the introduction of the UKCA mark replaced the previous CE mark. This certification is important to ensure that your medical device complies with the requirements of the UK Medical Device Regulation (UK MDR).
Which medical devices require UKCA certification?
In principle, all medical devices with higher classification levels to be sold in the UK market need to obtain UKCA certification. This includes newly launched products and already approved products.
Medical devices that require UKCA certification include but are not limited to: compression therapy equipment, defibrillators, infusion pumps, pacemakers, medical laser equipment, X-ray equipment, etc. However, specific requirements may vary based on factors such as the classification and purpose of the device. It is recommended that you consult a professional certification agency or relevant department to obtain more accurate information.
Who should I look for for UKCA certification?
To obtain UKCA certification for medical devices, manufacturers need to entrust a third-party organization called the UK Approved Body to conduct compliance assessment and certification that meets UKCA requirements.
What steps are required for UKCA certification?
The UKCA certification process includes product classification, technical document review, quality system assessment and final certification. All relevant requirements must be met to demonstrate compliance.
Determine product scope: Determine whether your product requires UKCA certification and the required scope of certification.
Preparation of documentation and testing: Prepare product technical documentation and conduct necessary testing and evaluation of the product to ensure compliance with relevant EU technical standards.
Entrust a certification body: Choose a UK-accredited certification body and entrust them to evaluate and certify your products.
Conduct an evaluation: The certification body will conduct an evaluation of the product, including a review of documentation and possible on-site evaluation.
Issuance of certificate: If the product meets the requirements, the certification body will issue a UKCA certification.
What time points do you need to pay attention to for UKCA certification?
The British government has implemented transitional arrangements for UKCA certification. For medical devices, this deadline was extended again in July 2023. The validity period depends on the medical device classification and the EU certificate type.
This means that medical device manufacturers can place their products on the UK market using both UKCA and CE markings before the specified date. It is recommended to apply for UKCA certification as early as possible to ensure timely market access and avoid delays.
Post time: Dec-28-2023