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UKCA Mark Certification

If you are a foreign manufacturer looking to know about the UKCA Mark certification Timeline, Consultants, and everything else that will help you obtain it, then you are on the right page.Cert 3 Global is always available to help you with the certification process, to help you achieve your goal of exporting to the UK Faster!
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UKCA MARKING

1)What is UKCA Marking?
If you want to sell your medical devices legally in the UK, then post Brexit (Britain’s Exit From the European Union) and according to the latest MHRA (Medicines and Health Products Regulatory Agency) Guidelines(Sept 18, 2019) , You require a UKCA Marking Certificate.

2)Where is the UKCA Applicable?
It is specifically for products placed on the market in the United Kingdom(including Scotland, England, Wales and Northern Ireland)

3)Difference between UKCA and CE?
The basic difference between the two are they are applicable in different locations from each other. CE marking is required to sell medical devices in the EU(European Union), Northern Ireland, and in some cases EEA(European Economic Area). Whereas UKCA Marking is applicable in the UK Market (including Scotland, England, Wales, and Northern Ireland) Both the markings are a sign that devices meet Necessary legal requirements and provide assurance to the Consumers of their safety, legality, and trust in using those products to their respective Citizens.

4) UKCA EXPERTS – CERT 3 GLOBAL
 We at CERT-3 Global help manufacturers obtain UKCA marking to sell their devices in the UK and assist in the end to end Evaluation Process which is done by an approved UK Body. Our team of experienced medical consultants and writers has helped a lot of manufacturers to seamlessly transition from CE marking to UKCA. You can “Request For Proposal” or Contact our office to know more and we are happy to help you.

UKCA TIMELINE

  • In order to facilitate uninterrupted trade and compliance, existing CE-marked devices are permissible to be sold until December 31, 2024. However, new products entering the UK market for the first time after January 1, 2023, must bear a valid UKCA mark.
  • The distinction between UKCA and CE certification boils down to administrative details. This signifies that UKCA mandates information in English and permits UK Approved Bodies to issue UKCA Mark certificates, unlike the previous Notified Bodies.
  • Despite these changes, the product range, technical requirements (including basic requirements and standards), and conformity assessment procedures remain unchanged.
  • CE-marked devices remain permissible for sale in the UK until June 30, 2023. However, as of July 1, all (IVD)In Vitro Diagnostic and medical devices must bear the UKCA mark to be legally marketed in the UK.
  • Regarding goods imported into Northern Ireland, UK manufacturers must designate an authorized European representative. CE marking remains mandatory in Northern Ireland, and compliance with EU MDR and EU IVDR regulations is still required.

UKCA CERTIFICATION CONSULTANTS

1)Creating Technical Documentation For Medical devices is not an individual’s task but requires a team of experts to work on it. At Cert-3 Global,we are a team of experts who specialize in preparation of Such highly technical documents.
2)Cert-3 Global assists in All technical Processes right from risk analysis, designing, safety evaluation, and conducting critical assessments. We strive continuously to provide top-notch technical documentation to our Clients. We are always there to help you create your Technical Documentation. Feel Free to reach out to us directly for assistance in creating your technical documentation.

  • Confirmation of device models and scope of UKCA certification
  • Identification of in vitro and medical device risk classes
  • Identification and finalization of testing standards and device standards
  • Identification of CE marking assessment path
  • Systematic ordering and organization of technical documentation/registrations
  • Coordination with OC during documentation review
  • Clinical Assessment Report on SPM, PMCF & PSUR
  • Risk Analysis
  • Medical Device Quality Management System Implementation
  • UDI Support
  • GMDN Confirmation

UKCA Technical File

Navigating the complexities of medical device technical documentation for UKCA branding can be daunting, especially for those in quality assurance and regulatory roles. Properly segmenting files based on purpose, application, and GMDN code is crucial for efficient processing.

Each document plays a significant role in ensuring the safety of a particular device.Mixing different products with varying purposes, classes, materials, or designs is strictly prohibited.

Here are the key Aspects to Consider:
  • Device purpose and instructions for use
  • Location of use
  • New or significantly changed design
  • State of the art
  • Incorporation of various directives/regulations
  • Evaluation of accessories, components, and software/firmware

UKCA APPROVED BODY

– Notified Bodies in the UK will have their accreditation withdrawn on 31 December 2020 and their CE marking will no longer be accepted for the marketing of medical devices and (IVDs) In vitro diagnostic devices on the UK market.
– After 31 December 2020 UK-based Notified Bodies will automatically become UK Conformity Assessment Bodies and their CE certificates will expire.
– Aquestion frequently asked by EU manufacturers : “Whether a CE Marking Certificate issued by an EU Notified Body will be accepted by a UKCA-approved body and used to issue a UKCA Certificate for the same medical device ?”
– The answer is that if the EU Notified Bodies are willing to share information with UKAB at the certificate holder’s request, UKAB can provide a UKCA certification without having to go through the whole process again.
– Cooperation between EBA and UKAB is essential. Therefore, we evaluate opportunities individually and instruct the producers accordingly. It is recalled that the conformity assessment includes an audit of the manufacturer’s quality management system and an examination of the technical documentation of the products that, according to certain criteria, must be CE marked. Therefore, if your EU Notified Body does not work with UKAB, further on-site audits and technical documentation reviews are required and manufacturers have to pay high fees for this process.
  • Identify the policies and standards that apply to you.
  • Re-check prerequisites
  • Conduct pre-clinical, safety and performance studies where applicable
  • Prepare technical dossier and declaration of conformity
  • Technical material to be submitted to a Conformity Assessment Body (UK CAB)
  • The on-site inspection was followed by a review of the technical documentation.

UKCA CERTIFICATION PROCESS

Allow the UKRP (UK Responsible Person) to guide you through the details of medical and IVD rules, covering all device classes and types. They manage any extra feedback from the UK MHRA and make sure communication is clear and complete. To tackle these challenges effectively, it takes more than just regulatory knowledge – it requires a blend of regulatory acumen, technical prowess, and scientific understanding. Beware of appointing a UK importer as your UK responsible person, as it may blur the lines between commercial interests and regulatory duties, which is not recommended.

The Team CERT-3 Global is a competent and reliable partner to become your UKRP (United Kingdom Resource Person). We possess the relevant experience and expertise to assist you end-to-end in this process. Feel Free to reach out to us (Phone Number Given Below) or You can “Send a Proposal”, and we will get back to you.

MHRA Registration

Before any medical device or in vitro diagnostic device can be introduced to the UK market, it must undergo registration with the Medicines and Healthcare Products Regulatory Agency (MHRA). Compliance with the Medical Devices Regulations 2002 (UK MDR 2002) is mandatory for devices placed on the market and registered with the MHRA.

Notification to MHRA is mandatory before placing devices on the UK market. Registration is required for manufacturers, sellers, renters, or lenders of:
  • Class I, IIa, IIb, or III devices (manufactured, refurbished, or re-labeled)
  • System or procedure packs containing medical devices
  • Custom-made devices
  • In vitro diagnostics (IVDs) undergoing performance evaluation or manufactured.

Important for Non-UK Manufacturers: Non-UK manufacturers must appoint a UK Responsible Person for registering items in the UK market from January 1, 2022. Failure to register devices will render them ineligible for legal sale in the United Kingdom.