UKCA marking with BSI
Certification process for UK regulation

DISCLAIMER:
Contents and process of this brochure refer only to new UKCA applicants not holding any CE Certificates with BSI.

UKCA Certification processThis guide will take you through our certification process starting from your application to BSI, to UKCA
Certificate issuing to your company.

Manufacturer
applies to BSI

Proposal

Following an initial discussion with our local commercial team, you will be given access tothe pre-application process through a digital interface. This provides us with the information
we need about your company and products to deliver you with an accurate proposal. Yourapplication should include the information detailed in the appropriate Annex of the UK
Regulation based on your chosen conformity assessment route.
BSI will generate a proposal based on the information you submitted through the digital
preapplication portal. Once accepted, the signed proposal will form the basis of thecontractual agreement between your organization and BSI. On receipt of the signed proposal,
BSI will assign you a dedicated team, including the Technical Specialist(s) responsible for thedocumentation reviews, a Scheme Manager to oversee certification activities, and a support
team who will coordinate your certification. This team will remain your point of contact for allof your currentand any future regulatory and certification needs.

Application andcontract review

QMSAssessment

Your Scheme Manager will review your application and resulting contract for completeness,requesting any additional information required to ensure that we assign appropriately
qualified Assessors to complete your initial certification.
A specialist Quality Management System (QMS) Auditor will be assigned to assess yoursystem to the QMS requirements of the Regulation through a two-stage assessment:
Stage 1 will review the completeness of your QMS, and Stage 2 will review the effective
implementation of your QMS and its compliance to the UK Regulation.** For devices that are sterile or end-user sterilized, additional assessment by our expert Microbiologists will be required.

TechnicalDocumentation

The Technical Specialist(s) with the relevant product expertise will be assigned to conduct
your Product Assessment. The exact details will be based on your device classification andthe appropriate conformity assessment route. Your Technical Specialist(s) will review thecompleteness and content of your documentation, including any additional documents or test
results that provide evidence of conformity to the Regulation. They will ask rounds of questions
where any gaps are identified. Your product(s) may be subject to additional assessment byspecialist reviewers or consultation with the MHRA.

Final Certification
Review

Once the QMS and Product Assessments have confirmed compliance to the applicablerequirements, your Scheme Manager will conduct a final review of the activities undertaken
and, if satisfied that the requirements are met, will prepare a certification recommendation.
They will then submit the information for final BSI Certification Decision.

CertificationDecision

BSI certification is subject to a final internal approval process, consisting of a Technical andRegulatory Compliance check and a Quality and Internal Compliance check. This allows
verification of, and consistency in, BSI certification recommendations. These final reviews are
conducted by BSI staff with the appropriate technical and compliance competence.

Certificate
IssuedUKCA marking with BSI

Once approved, your certificates will be issued electronically to your organization.
Note: As a UK Approved Body, BSI cannot offer consultancy advice, only auditing services.

2

UKCA Certification: step by stepYour application
Your application for UKCA Certification must include
the following information as per the appropriate
Conformity Assessment Annex of the UK Regulation.
This information will be reviewed as part of theQMS
and Technical Documentation audits:•Details of the legal manufacturer, including
name, registered business address and themanufacturing sites covered by the QMS•

Details of the UK Responsible Person, including
name and registered business address (ifapplicable), and details of any subcontractors•Product details including name, classification
and rationale, accessories, description, intended
use and market history (if available) for device
or device group covered by the QMS•

Applicable UK legislation and standards and any
test results demonstrating conformity•

Draft Declaration of Conformity for the device
model covered by the scope of the certification•Information of any application to another UK
Approved Body for certification of the samedevice(s), including application for certificationof a QMS covering this device. If you have notapplied to another UK Approved Body, pleasestate this explicitly in writing•The QMS documentation, including thedocuments and procedures that describe how
the manufacturer will fulfil the QMS
requirements of the UK Regulation, and how
they will apply them to maintain an effective
and adequate QMS•

Evidence of conformity to the EssentialRequirements•

Risk management processes, including benefitrisk analysis•

Information on the design and manufactureof the devices, including product and software
verification and validation processes,
biocompatibility testing, stability, shelf-lifeand product lifetime

UKCA marking with BSI•

The Clinical/Performance Evaluation plan andany procedures to maintain it, taking into
account state of the art•

The documents detailing the manufacturer’s
Post-Market Surveillance (PMS) and Post-Market
Clinical Follow-up (PMCF) procedures (ifapplicable), including details on how themanufacturers will meet the requirements of
the UK Legislation, and the procedures thatmaintain the PMS and PMCF systems•

Information on how the manufacturer will meet
any vigilance requirements, and explanation of
how these procedures will be implemented•

User information including IFU and labelling•

Evidence of conformity to the requirements forany special processesYour devices may be subject
to additional assessment from:
A microbiologist
A clinician
A statistician
A toxicologist
A medicinal product expert
An animal/human derivative expert
A software expert
An MRI compatibility expert
The MRHA

Get in touch
Whether you are starting the certification
process, looking to transfer or need to discuss
your options, we can guide you through theprocess.

Request a quote3

Product Assessment

Submission requirements

Technical Documentation review andsampling plans

Language of Technical Documentation

The requirements for Technical Documentation
review will vary based on the certificate type:•For devices assessed under a Quality Systembased Annex, the Technical File will be subject tosampling. Your BSI team will request the File tobe sampled•

For devices assessed under a Product SpecificAnnex, each device will be subject to a DesignDossier review

Note: There may be some additional assessments required
based on your product type and its classification, as advised byyour BSI team.

Your supply chain
The UK Regulation details requirements forsuppliers, subcontractors, UK Responsible Personand other economic operators in your supply chain,including importers and distributors. It’s important
to note that:•Contracts and agreements with these partiesare required as demonstration of control of yoursupply chain•

All critical subcontractors are required to hold valid
ISO 13485 or MDSAP certification issued by an UK
Approved Body or one of its recognised ordesignated subsidiaries. Some crucial suppliers
may require appropriate certification based on thenature of the materials provided. If this is not thecase, the critical subcontractor or crucial supplier
may be subject to a verification audit by BSI•

BSI may carry out Unannounced Audits at thelegal manufacturer locations, or their criticalsubcontractors and crucial suppliers

BSI resources•FAQs UKCA for
Medical Devices
and IVDs•

UKCA Marking•

Whitepapers

Additional resources•

UK Regulation

UKCA marking with BSI•

All submitted Technical Documentation and test
results must be in the English language. Exceptions
may be allowed in the case of voluntary change ofApproved Body (Transfer from another Approved
Body to BSI). Please contact the BSI AccountManager or your BSI Scheme Manager for further
details in case of Transfers.

Language of QMS Documentation
QMS Documentation may be in a local language.
However, BSI’s ability to support local languages issubject to auditor availability with the required
language and technology skills and hence may havean impact on the audit planning. Additional time
may be added to the audits if translation is required
during the audit. Please contact the BSI AccountManager or your BSI Scheme Manager for further
details.

Submission method

Documents should be submitted via the secure BSIElectronic Client Portal.

Documentation to be submitted
Make sure you include the Technical Documentation,
the required elements of your QMS, and the signed,
approved proposal when first submitting
documentation to BSI. Signatures should bepresent where required.

Document format
The preferred document format is a paginated,bookmarked PDF utilizing Optical Character
Recognition (OCR, searchable format).

Post certification activities
Once you are UKCA certified, BSI will continueto
assess you through regular audits, including:•QMS surveillance audits•

Technical audits for your UKCA certification•Microbiology assessments, if applicable•Unannounced audits

MHRA website
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