a blog about how you can get recertified for the UKCA and the process.

Before jumping to the process directly, first let us know what is UKCA Marking,
The United Kingdom Conformity Assessment (UKCA Mark) is the UK equivalent of the EU CE Marking. This Mark is a valid indicator that a medical device conforms to relevant UK Regulations. The United kingdom conformity assessment marking is mandatory for medical devices sold in Great Britain (England, Wales, and Scotland) post Brexit.

A third-party evaluation procedure by a UK Approved Body is required for UKCA Mark of medical devices sold in the UK. This procedure is comparable to that used in the European Union for CE Marking, in which the EU authorized Notified Body assesses the compliance. The MHRA has stated that UKCA Marking will be based on the IVD, MDD and AIMD Directives until June 30, 2023, rather than the EU MDR 745/2017 and EU IVDR 746/2017.

UKCA and Role of Consultants

To get you UKCA Marking, you will need to hire professionals that covers all the technical areas such as risk analysis, validations, design, shelf-life, usability, biological evaluation, safety, chemical characteristics, and clinical evaluation, the consultant that covers and has expertise in all these areas will help you to get the UKCA Marking easily.

Responsibilities of Consultants :

• Confirmation device models and scope of UKCA Mark Certification
• Identification of Medical and Invitro device risk class
• Identification and finalization of test standards and device specific standards
• Identification of assessment route of CE Marking
• Systematically organize and arrange Technical Documentation / Files
• Coordination with CB during review
• Clinical Evaluation Report documentation covering PMS, PMCF & PSUR
• Risk Analysis
• Medical Device Quality Management System Implementation
• UDI support
• GMDN confirmation
• Consultants would also be responsible for preparing technical file.

Technical File Includes,

• Device Intended use and Indication of use
• Site of application
• Design change or major constructional changes
• State of the art
• Addition of multiple directives/ regulation
• Evaluation of accessories, components and software/firmware

The Best Consultant for getting UKCA Marking is I3C Global Services, It is a leading partner of small, medium and large scale healthcare manufacturer all over the world, headquarters in India and Bangalore.

Now, we know basics about UKCA Marking and Consultants, So let's discuss the process of Certification of UKCA.

Process Of UKCA Certification:

The following are typical UKCA Conformity Assessment Steps:

1. Identify the directives and standards that apply to you.
2. double-check the prerequisites
3. If relevant, conduct pre-clinical, safety, and performance investigations
4. Prepare a technical file and a compliance statement
5. The technical material should be submitted to the Conformity Assessment Body (UK CAB)
6. The onsite inspection was followed by a review of the technical files.

UKCA has always been perceived as one of the top certification bodies in the world. And it is not without any reason. Now when you talk about UKCA certification, please keep in mind that they only offer valid certifications to consultants who have undergone training from certified professional body and can perform to their standards. The performance evaluation is designed by UKCA based on certain specification and then evaluated by the accredited assessor who is occasionally monitored by UKCA for his/her consistency. And it becomes very important to hire a consultant while applying for the UKCA Marking process.

Please visit here at:- European Authorized Representative