UKCA Mark Certification Experts

At Cert3Global, we are providing efficient and affordable solutions to all the medical device manufacturers and exporters who are seeking UKCA Mark certification. Our team of medical writers and consultants have extensive knowledge as well as experience in assisting such manufacturers with the seamless transition from CE to UKCA Marking, that will help in handling new applications.

Understanding UKCA Marking

UKCA Marking with Cert3Global acts as a reliable indicator that a medical device complies with the relevant regulations in the country. Guidelines issued by the Medicines and Health Care products Regulatory Agency (MHRA) of the United Kingdom on September 18, 2019, brought forth new regulations to govern medical devices post-Brexit. However, it is important to note that the UKCA Marking is not recognized within the EEA, EU, as well as in Northern Ireland. To sell products in these markets, the CE marking will be a very crucial requirement. Exporters, their authorized person, and manufacturers will have the responsibility of affixing the UKCA marking on the products, following a similar principle as the CE marking but specifically for the UK market.

We at Cert3Global helps manufacturers in obtaining the UKCA Marking for medical devices sold in the UK. This will be a necessary third-party evaluation procedure conducted by a UK Approved Body. This process mirrors the evaluation used in the European Union for CE Marking, where an EU authorized Notified Body assesses compliance.

UKCA Certification and MHRA Registration Timeline

In order to enable free trade without eavesdropping, existing CE-marked devices are permitted until December 31, 2021. However, new products entering the UK market for the first time after 1 January 2021 must carry a valid UKCA mark.

The difference between UKCA and CE certification is administrative. This reflects the fact that the UKCA requires information in English and that UK Approved Bodies are allowed to issue UKCA Mark certificates, unlike previously Notified Bodies. The product range, the technical requirements (basic requirements, standards) and the conformity assessment procedures remain the same.

CE marked devices can still be sold in the UK until 30 June 2023, but from 1 July all in vitro diagnostic and medical devices must carry the UKCA mark to be marketed in the UK. Bringing goods into Northern Ireland: UK manufacturers must appoint an authorized European representative for bringing goods into the EU or Northern Ireland. CE marking is required in Northern Ireland and EU MDR and EU IVDR regulations apply.

UKCA CERTIFICATION CONSULTANTS

No one can be called a master at creating technical documentation for medical devices. A group of experienced professionals in CE marking of EU medical devices, covering key technical areas such as risk analysis, validations, design, durability, usability, biological evaluation, safety, chemical properties and clinical evaluation are designated as experts, making us one Team called I3CGLOBAL. You can contact us directly to create the 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

It is common for members of quality assurance and regulatory bodies to find the required amount of medical device technical documentation for devices intended for the UKCA brand. Proper segmentation of technical files by purpose, application, and GMDN code is essential for fast file processing.

Please note that the technical documentation or documentation of the medical device applies only to the device to determine its safety and performance. This means that you cannot mix and match products with different purpose, different class, different construction material or even different design.

• Device Purpose and instructions for use
• Location of use
• New design or significant change in design
• State of the art
• Addition of various directives/regulations
• Evaluation of accessories, components and software/firmware

UK Conformity Assessment Bodies

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 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.

A question frequently asked by EU manufacturers is 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.

The UK Responsible Person for Medical Devices and IVD

The excellent UKRP guides you through the medical and IVD regulations for all classes and types of device, assists you with further comments from the UK MHRA and communicates effectively and comprehensively.

All of this requires exceptional regulatory, technological and scientific skills, as well as the necessary manpower. The I3CGLOBAL team has the experience and qualifications to serve as the ideal UK Responsible Person. It is not a good idea to appoint a UK importer as the UK responsible person to separate UK commercial and regulatory interests.

Medical Device and Invitro Diagnostics MHRA Registration

From 1 January 2021, all medical devices and in vitro diagnostics must be registered with the MHRA before being placed on the UK market. Instead, the registration of medical devices is graded according to the risk class of the devices. devices and the GMDN code

The UK MDR 2002 requires you to notify the MHRA before placing your device on the market in the United Kingdom. If you or your business sells, rents, or lends, you must register.

• Class I, IIa, IIb, or III devices you have manufactured
• Class I, IIa, IIb, or III devices you have refurbished or re-labeled
• Any system or procedure pack containing at least one medical device
• Custom-made devices
• IVDs you have manufactured
• IVDs undergoing performance evaluation