UL LLC, UL Solutions
medical regulatory services
Program requirements

LET’S GO

© 2024 UL LLC. All rights reserved.

At of the date of issuance of this document,
UL LLC is accredited by the following
accreditation bodies for its medical
and regulatory certification services.
The scope of accreditation can beobtained directly from the website of theaccreditation body, and this information
may be used by registered customers tofulfill supplier qualification of UL LLC.

United Kingdom Accreditation Service
ISO 13485 and ISO 9001
https://www.ukas.com
UKAS is a member of the International Accreditation Forum(IAF) Multilateral Recognition Arrangement
https://iaf.nu/

Medical Device Single Audit Program
Recognized Auditing Organization
https://www.fda.gov/medical-devices/cdrh-internationalprograms/medical-device-single-audit-program-mdsap

UK Conformity Assessed Approved Body
https://www.gov.uk/government/publications/medicaldevices-uk-approved-bodies

UL.com/Solutions

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Table of contents
1.0

Scope

4

2.0 Applicable documents

5

3.0 Terms and definitions

6

4.0 UL Solutions quality management
system program requirements

5.0 Compliance with UL Solutions
program requirements

14

6.0 UL Solutions medical
regulatory services

16

6.1

8

4.1 General

8

4.2 The customer shall:

9

Prior to the on-site visit

16

6.2 Audits

16

6.3 Nonconformities

18

6.4 Issuing certifications

19

6.5 Maintenance of certification

19
19

4.3 As a certificate holder under
UL Solutions’ MDSAP, thecustomer shall:

10

6.6 Suspension or withdrawalof certificates

4.4 As a certificate holder under
UL Solutions’ UKCA program,the customer shall:

6.7 Complaints

19

11

6.8 Complaints about UL Solutions
certified customers

21

4.5 UL Solutions shall:

13

6.9 Disputes and appeals

21

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7.0

UL Solutions’ regulatory programs 24
7.1

Medical Devices
Single Audit Program

7.2 UKCA program

24
24

Appendix A — Conditions for useof an accreditation body mark26

A.1 Requirements for useof the UKAS mark26

A.2 Requirements for useof the UKCA marking

27

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1.0 Scope
1.1
Program requirements provided by UL Solutions
medical regulatory services, hereafter referred to as“UL Solutions,” are designed to support customers’
compliance with the services listed below in accordancewith contracted certifications:• ISO Management System Certification Services
for ISO 13485 and ISO 9001
• Medical Devices Single Audit Program (MDSAP)Management System Certification Services• UK Conformity Assessed (UKCA) certification
under the Medical Devices Regulations 2002 UK
Approved Body Services
1.2
These program requirements supplement the Global
Services Agreement (GSA) program’s specific services
terms and conditions, which can be viewed here.

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1.3
The objective of these program requirements is toprovide, by evaluation and applicable audits — i.e.,
registration audits, surveillance audits, recertification
audits — conformity assessments and independent
verification of a customer’s quality management system’s(QMS) capability to consistently provide products and/or
services that conform to given specifications.
1.4
This document identifies and describes the requirementsfor our certification services, including the use of ourMarks, and ongoing activities to maintain certification.
1.5
By following these program requirements, customers

allow UL Solutions to support the relevant certification
programs. Additional applicable regulatory requirements
also apply that may not be defined in this document.

1.6
UL Solutions certified customers must adhere torequirements of this document and applicableregulatory requirements as a condition of certification.
The requirements stated in this document are expected
to be implemented within the customer’s QMS and areconsidered auditable criteria.
1.7
These requirements may be modified or supplemented
by UL Solutions at any time. For the most up-to-dateversion of UL Solutions’ medical regulatory services
program requirements (Customer Support GuidanceULID-000703), please check the UL Solutions website
at Quality Management System (QMS) Audit Service | UL
or contact your UL Solutions representative.

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2.0 Applicable documents• ISO 9000:2015, Quality Management
Systems – Fundamentals and Vocabulary• ISO 9001:2015, Quality Management
Systems – Requirements• ISO 9004:2018, Quality Management Systems –Quality of an Organization – Guidance to Achieve
Sustained Success• ISO 17021-1:2017, Conformity Assessment –Requirements for Bodies Providing Audit and Certificationof Management Systems, Part 1: Requirements• ISO 19011:2018, Guidelines for Auditing
Management Systems• ISO 13485:2016, Medical Devices – Quality Management
Systems – Requirements for Regulatory Purposes• MDSAP audit model – MDSAP AU P0002• UL Solutions Global Services Agreement, Program-Specific
Service Terms and other certification contracts between
UL Solutions and the customer

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3.0 Terms and definitions
3.1 Quality management standards
The standards for quality systems published by theInternational Organization for Standardization (ISO); thecertificate of registration may also denote conformancewith equivalent series standards such as European Norm
(EN), American National Standards Institute (ANSI) andCanadian Standards Association (CSA) standards.
3.2 Quality management system
The organizational structure, responsibilities, procedures,processes and resources for implementing a quality
management system
3.3 Customer
The party that is responsible for the product, process orservice and can ensure that quality assurance is exercised;
this definition may apply to manufacturers, distributors,
importers, assemblers, service organizations, etc. A customerthat is granted certification by UL Solutions is a legal
entity — an incorporated or unincorporated body — thathas been issued a certificate. This customer subscribes
to UL Solutions medical regulatory services and istherefore responsible for complying with UL Solutions

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requirements and for UL Solutions invoices associatedwith the certification and associated audits.
3.4 Management representative
A member of the customer’s management who represents
the evaluated facility and is responsible for the customer’s
QMS as it pertains to the relevant products and/or
services covered in the customer’s scope of registration

3.7 SiteAny physical location that is associated with design
and/or production of the product3.8 Off-site
Any physical location that provides QMS activities
other than design and/or production, i.e., warehousing,customer service, etc.

3.5 Certification
A decision by UL Solutions that a customer’s QMS meetsthe requirements of a specific management system standard
and UL Solutions program requirements; a certificate isissued to the customer to indicate acceptance into the
UL Solutions medical regulatory services program.

3.9 Certificate
A document recognizing that the scope and QMS
implemented by the customer and audited by UL Solutions
is in accordance with a specific management systemstandard and UL Solutions program requirements; allcertificates are issued electronically by UL Solutions.

3.6 Certificate scope
A certificate scope describes the type of activities,
products and services as applicable at each physicalsite without being misleading or ambiguous. The scope
describes the relevant process, product and/or service
areas that are provided under the customer’s quality
system. Proposed certificate scopes are agreed on prior
to the certification audit. All sites and off-sites must be
included in the applicable certificate scope for QMSs.

3.10 Certification audit
The initial evaluation performed by UL Solutions todetermine the compliance of the customer’s QMS
with the applicable standard(s) and/or regulations;certification audit activity consists of a Stage 1
Readiness Audit and a Stage 2 Certification Audit.

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3.11 Surveillance audit
An audit performed by UL Solutions to determine acustomer’s continued compliance with the applicablestandard and the requirements listed in this document
following certification; these audits are typically scheduled
three (3) to six (6) months in advance of an audit due date set
in relation to the certification audit activity and certification
cycle. Audit agendas are provided at least two (2) weeks prior
to the audit start date. UL Solutions also reserves the rightto perform unannounced and/or short-notice for-cause
surveillance audits to investigate complaints, changes,
concerns or as follow-up on suspended certificates.
3.12 Recertification audit
The evaluation performed by UL Solutions to confirm
compliance of the customer’s QMS with the applicablestandard and the requirements in this document at theend of the customer’s certificate cycle; a recertification
audit is also known as a triennial audit.

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3.13 Recertification assessment
The evaluation performed by UL Solutions to confirm
compliance under the UKCA program at the endof the customer’s UKCA certificate cycle

3.16 UL Solutions Management System Enhanced MarkThe UL Solutions Management System Enhanced Markis displayed on UL Solutions-issued management system
program certificates only.

3.14 UL Solutions
UL LLC, UL Solutions medical regulatory services
and its affiliates

3.17 UL Solutions Management System Promotional Badge
Customers may use the UL Solutions Management System
Promotional Badge in accordance with UL Solutions
certification agreements to promote their facility registration.

3.15 UL Product iQ®

An online certification directory containing a list of
the customers that are issued certificates of registration
by UL Solutions to at least one of the QMS standards;
descriptions define a customer’s name, address,
scope of registration and the certificate issue date.
This information is available electronically on the
UL Solutions website at www.UL.com or in the ProductiQ database. A login account may need to be createdto access information on the Product iQ site.

Information and marketing guidelines are available from theMarks and Label Hub. No use on products/product packaging.
No other use of marks/badges is permitted.

UL Solutions Management Systems
Promotional Badge example
Marks and Label Hub | UL Solutions

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4.0 UL Solutions Management System
Certification Services Program requirements
4.1 General
4.1.1 UL Solutions is the sole authority by which
UL Solutions certificates may be issued.
4.1.2 Customers capable of demonstrating a legitimate
business that complies with these program requirements
shall be entitled to a certificate that remains the propertyof UL Solutions. All UL Solutions certificates are provided
electronically and must be destroyed upon termination.
4.1.3 All customers certified under UL Solutions’ scopeof accreditation will have one or more accreditationbody marks appear with the UL Solutions Management
System Enhanced Mark on their certificate.
4.1.4 A separate certificate is issued for eachprogram following application and successful
evaluation to confirm compliance.

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4.1.5 Certificates are renewed in accordance with theexpiry date indicated on the certificate unless cancellation,suspension or withdrawal occurs. If a customer does
not intend to renew an issued and active certificate,
notification must be sent to UL Solutions in writing detailingsuch intentions no later than 60 days prior to certificate
expiry renewal.
4.1.6 A customer’s right to use certificates issued
by UL Solutions is not transferable to any other person,
customer or corporation without UL Solutions’written authorization.
4.1.7 The customer agrees to comply with all applicablelaws, statutes and regulations, e.g., state, region, province,
country, etc.
4.1.8 The customer shall report incidents to respective
regulatory authorities in line with the local country’s laws
and regulations.

4.1.9 UL Solutions is required to be notified of the reported
incident where the device is CE certified under any
UL Solutions partner notified body as applicable.
4.1.10 Where incidents occur to products covered
outside of CE certification, the customer is required only
to inform UL Solutions of any incidents leading to productrecalls, advisory notices and where the incident leads
to a significant change in processes. This includes
products covered under the UKCA marking.
4.1.11 Should a UL Solutions representative identify
items that are not in compliance with this document or
the applicable standard and other applicable criteria,
the customer shall either correct such items or cancel
registration and immediately refrain from any further
reference to UL Solutions and the certification program.

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4.1.12 If it is reported that the customer’s QMS for goods
or services under the applicable certificate scope is notin compliance with this document or applicable standards,
the customer shall cooperate with and assist UL Solutions
in obtaining the relevant information. This includes sharing
any information the customer acquires concerning thereported noncompliance and reporting to UL Solutions
concerning corrective actions taken to address
any noncompliance within an agreed period of time.
4.2 The customer shall:
4.2.1 Comply with UL Solutions program
requirements at all times.
4.2.2 Maintain and document a QMS in accordancewith the requirements of the applicable standard(s)and make available copies of that documented QMS(or any parts thereof) upon UL Solutions’ request.
4.2.3 Notify UL Solutions in writing of significant changes
to the management system. Please use the Manufacturers’Significant Change Notification Form, Form-ULID-000717(formerly 00-MB-F0853), available upon request.

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Significant changes requiring notification to
UL Solutions include:• Increases/decreases in staff that exceed 20%
of total headcount reported during previous audit• Change of management representative or primary or
secondary contacts, and any changes to contact details• Change of legal entity name
• Change of address of sites or off-sites listed on
certificate(s); addition/removal of sites or off-sites• Expansions or reductions to certificate scope(s)• New manufacturing technologies used
• Significant changes to existing manufacturing processes• Significant changes to outsourced processes (whole
product design, greater than 75% of product manufacturing,
software design and development, sterilization)
For all items above, notification shall be provided at least 10
weeks in advance of the date the change becomes effectiveor the start of that activity. UL Solutions shall evaluate
whether additional audit activity is necessary for verifying
certification conformance in relation to any changes.

All such notifications shall be made by email toInform.Regulatory@UL.com using the Manufacturer’s
Significant Change Notification Form (Form-ULID-000717).
4.2.4 Discontinue any use of the UL Solutions Management

System Promotional Badge that is unacceptable to
UL Solutions and any form or statement of reference that in
the opinion of UL Solutions might be misleading. The customer
shall not use certification in such a manner as to bring into
disrepute or cause loss of public trust to UL Solutions,its affiliates, representatives or the certification system.
4.2.5 Ensure that any purchased finished products, processesor services covered under the customer’s certificate scopecomply with the assessed capability of the program by
UL Solutions. If any finished products, processes or services
are produced or provided external to the customer’s QMS, theexternal producer or provider may also be evaluated during
the certification process. This may require an on-site audit of
the external producer or provider by the UL Solutions Audit
team. In cases where products described in the certificate
scope are not traceable to a QMS certification that isrecognized by UL Solutions, the customer shall establish
and operate a procedure for notifying the prospective
customer that the items in question have not been produced
or provided within UL Solutions’ certification program.

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4.2.6 Give the representatives of UL Solutions and any
observers (including but not limited to accreditation body
representatives, regulatory body representatives, other
UL enterprise observers and UL Solutions trainees)
appropriate access during normal working hours forthe purpose of examining systems, processes,
methods of test and records.
4.2.7 Extend all necessary privileges and assistance to
UL Solutions representatives and observers, including healthand safety conditions, so the representatives may properly
perform their function under UL Solutions’ certificationor surveillance audit service, and make all written material
utilizing the UL Solutions Management System Promotional
Badge and other means of displaying UL Solutions certification
available for audit by a UL Solutions representative.
4.2.8 Nominate a management representative andone or more deputies authorized to act in the main
nominee’s absence (and replacement nominees as may
be necessary) who shall be responsible for all matters inconnection with the requirements of the certification.

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4.2.9 Refrain from using any report or certificate issued
as the result of a UL Solutions audit to indicate that a
product is Listed, Classified or Recognized by UL Solutions,or as the basis of any oral or written representation
to suggest that any product or system has been or is
Listed, Classified or Recognized by UL Solutions.
4.2.10 Refrain from releasing any information referencing
UL Solutions’ audit acceptance, certification and/or
certification of the facility before it is established andconfirmed in writing by UL Solutions.
4.2.11 Make available to UL Solutions, when requested,
the records of all complaints and corrective action taken,
in accordance with the requirements of the QMS standards
or other normative documents.
4.3 As a certificate holder under UL Solutions’
MDSAP Management System Certification
Services, the customer shall:
4.3.1 Receive an audit report specific to each site
under the QMS.
4.3.2 Agree that the audit report generated is shared to all
jurisdictions participating in the MDSAP where the customer
has market access. Additionally, the customer agrees that
regulatory authorities may share all documents and records

related to the audits with other regulatory authorities
that have formal established confidentiality agreements
between governments to cover provisions for protecting
proprietary information and trade secret information.
4.3.3 Agree that the audit findings generated fromany audit will be shared among all jurisdictions where
the customer has market access in the MDSAP.
4.3.4 Agree to the nonconformity grading system per
the International Medical Device Regulators Forum(IMDRF) Global Harmonization Task Force (GHTF) Study
Group 3 (SG3), document GHTF/SG3/N19:2012.
4.3.5 Agree to the composition of the Audit team per therequirements of IMDRF/MDSAP WG/N3 Final:2016 (Edition 2).
4.3.6 Agree that the MDSAP does not absolve the customerof potential unannounced audits by a regulatory authority(U.S. Food and Drug Administration (FDA), Health Canada,Agência Nacional de Vigilância Sanitária (ANVISA),
Therapeutic Goods Administration (TGA), Pharmaceuticals
Medical Devices Agency (PMDA), etc.) as determined
per the requirements of GHTF/SG3/N19:2012 for one ormore nonconformity(s) graded as a 5, or more than two
nonconformities graded as a 4.

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An unannounced audit will minimally require two auditors
for one day on site.
If specific information provides reasons to suspect serious
nonconformities of the devices or if a regulatory bodyrequests that UL Solutions conduct an unannounced audit,
the audit shall focus on the specific information of the serious
nonconformities or request of the regulatory authority.
The unannounced audits may occur at the customer premises
or the premises of the contracted critical suppliers. If avisa is needed to visit the country where the customer islocated, the contractual arrangements shall contain, as anannex, an invitation to visit the customer or the contracted
critical supplier at any time and an invitation that leaves
the date of visit open. The contractual arrangements shallalso contain, as an annex, similar invitations issued by
the critical suppliers. The contractual arrangements shallauthorize the auditing organization to end the contract assoon as permanent unannounced access to the premisesof the customer or the contracted critical suppliers are
no longer assured. The contractual arrangements shallfurthermore cover the measures to be taken by the auditingorganization to ensure the security of their auditors,
and shall provide for financial compensation for theunannounced audits, including security arrangements.

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4.3.7 Agree that all documentation associated with thecurrent certification cycle and valid certificates may beshared with the next auditing organization (registrar) uponrequest, should the customer end the relationship for the
MDSAP and/or manufacturing site(s) with UL Solutions.
4.4 As a UKCA certificate holder under UL Solutions’
UK Approved Body Services in compliance with theMedical Devices Regulations 2002, the customer shall:
4.4.1 Implement and maintain a quality system to ensure
conformity with the applicable directives and regulations.
4.4.2 Immediately notify the Medicines and
Healthcare Products Regulatory Agency (MHRA)
and UL Solutions of any incident involving productsafety or noncompliance with the applicable directive
and/or regulation. Information on the investigations,corrective actions taken and the final reportmust be provided.
4.4.3 Submit notifications to Inform.Regulatory@UL.com.
4.4.4 Retain documentation and reports relating to the
products covered by UL Solutions UKCA certification forthe design life of the product and in any case not less than
five years after the last product has been manufactured.
This specifically includes but is not limited to technicaldocumentation, declarations of conformity, U.K. approved
body certificates and decisions. These documents are
required to be available to the MHRA for the periodof time stated.

4.4.5 Establish processes to ensure availability of relevant
personnel to support unannounced audits of the customer’sfacilities and/or any critical subcontractors/suppliers.
Notifications of facility shutdowns or changes in shift patterns
potentially affecting the execution of an unannounced
audit shall be sent to Inform.Regulatory@UL.com.
4.4.6 Establish appropriate arrangements with suppliers
to ensure that UL Solutions auditors will gain access to thefacilities in a timely manner to conduct an unannounced audit.
4.4.7 Promptly inform the UL Solutions approved bodyof any significant changes where:• For product changes, the change would affectconformity with the essential requirements and/or
the conditions prescribed for the intended use of thedevice. The customer shall inform the approved bodythat issued the UKCA design examination certificate ofany significant change made to the approved design(including manufacture and final inspection).
• For changes to the quality system, either the change
would affect compliance of the devices covered by thequality system with the essential requirements or theapproved type/design, or the change means additions
to the product range covered by the quality system. The
customer shall inform the approved body that approved
the quality system of any plan for substantial changes
to the quality system or the product range covered.

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4.4.8 For product changes, the matters that are consideredwhen deciding whether changes are significant include
the following:• Does the change introduce a new device, device variant,or new hazards which have not been previously addressed?
• Does the change adversely affect the risk associatedwith existing hazards?
• Does the change alter the design or details of an
existing device regarding overall design solutions or
significant changes to the manufacture or supply of

essential components of the device, and/or affectcompliance with the essential requirements given in
the device master record submitted to UL Solutions?

• Does the change alter the intended purpose, indications
for use, or method of use of the device?
• Does the change mean that the device will havedifferent end users, or be used in a different manner,or for a different purpose?
• Does the change impact the performance claims of thedevice or require new clinical or other performance studies
to support continued compliance with requirements?
• Are there major changes to the manufacture of thedevice, for example: change of manufacturing site,
new manufacturing technologies, major changes to the
manufacturing processes that require significant
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validation to establish equivalence, or changes to
product release procedures and/or specifications?
4.4.9 For quality system changes, the mattersthat are considered when deciding whether changes
are significant include the following:• Does the change alter the manufacturing technologies?
• Does the change affect the product conformity route?
• Does the change affect the continued complianceof the quality system with the relevant harmonized
standards against which it has been approved?
• Does the change affect the arrangements for ensuringcontinued compliance with the requirements ofthe directive, e.g., verification, validation, etc.?
• Does the change require that manufacturing
processes and controls are revalidated?
4.4.10 A notification of any significant change in thedesign/device as well as in the quality system will include,
as necessary:• A brief description of the modifications compared to theapproved design/device or the approved quality system• The reason for the changes/modifications• In the case of design/device changes, a statementon the relevance to its compliance with theessential requirements of the directive
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4.5 UL Solutions shall:
4.5.1 Issue an electronic certificate to the customer
valid for an appropriate period of time (no morethan three to five years maximum, depending on the
program) as determined by applicable requirements
and the final review certification decision.
4.5.2 Send an auditor or audit team to the customer
at its discretion — not less than once per year — to allsites in which the customer is manufacturing goods,
operating processes or offering a service for which it iscertified for the purpose of verifying that the obligations
imposed by the certificate are being carried out.
4.5.3 Conduct annual surveillance audits to monitor thematurity and continued effectiveness of the QMS, including
the audit of management review, complaint handling,internal audits, corrective action, preventive action,effectiveness of meeting quality objectives, continual
improvement (where applicable), conformity of regulatory
requirements and use of marks (including accreditationbody marks) and other references to certification.

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4.5.4 Refrain from disclosing any information concerning
the customer that is of a confidential nature without
the customer’s prior authorization in writing other thaninformation that has been made publicly accessible by
the customer. Information about a particular product or
supplier shall not be disclosed to a third party without
the written consent of the supplier, except as required byregulatory authorities for matters of regulatory complianceor protection of public health. Where law requires
information to be disclosed to a third party, UL Solutions
shall inform the supplier of the information provided.
4.5.5 Ensure the safe handling of all confidential
information by using secure facilities and systems for the
storage and transmission of documents and records.
4.5.6 Conduct audits and maintain registration withthe highest levels of impartiality, evaluating only thefacts presented against the requirements of the audit
criteria without regard to any other interest.

4.5.7 Demonstrate responsibility for ensuring that all
relevant and applicable information, scientific principles
and ethical standards in determining the acceptabilityof information are upheld in all dealings with customers,
accreditation bodies, regulatory authorities andother stakeholders.
4.5.8 Ensure that persons conducting audits havedemonstrated competence for the activities they
are evaluating.
4.5.9 Provide transparency regarding audits and methodology
to customers with certificates or that are seeking certification.
4.5.10 Notify the customer at its discretion of customer
complaints relating to the compliance of its product,
process or service with the specified requirements.
4.5.11 Direct its representative(s) to exercise due care incomplying with any safety regulations that may be applicablegenerally to the customer’s facility personnel who are
implementing the QMS.

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5.0 Compliance with UL Solutions program requirements
5.1
If a customer is temporarily unable to comply withthese program requirements, UL Solutions may require
the customer to discontinue use of the UL Solutions
Management System Promotional Badge and any claim tocertification under a certificate suspension as describedin Section 6.7. In this event, customers must notify theirend customers of the suspension until the conditionsof certification are achieved again or pending the resultof an appeal as described under Section 6.10.

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5.2
If the customer fails to comply with these program
requirements, UL Solutions may, subject to the provisions
in Section 6.7, as appropriate:• Withdraw the certificate.
• Refuse to issue or renew the certificate.
• Change/limit the certificate scope.
• Notify vendors, regulatory authorities and potential usersof improper or unauthorized use of the UL Mark or badge
or improper or unauthorized reference to UL Solutions.

5.3
UL Solutions may, at its discretion and subject to theprovisions in Section 6.7, withdraw or refuse to issue or
renew a certificate if the customer becomes subject tobankruptcy laws or makes any arrangements or composition
with its creditors; enters into liquidation, whether
compulsory or voluntary (but not including liquidation
for the purpose of reconstruction); has a receiver of its
business appointed; or is convicted of an offense tending
to discredit the customer’s reputation and good faith
as a trader. Such decisions and the grounds for themshall be communicated to the customer in writing.

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5.4
In the event that UL Solutions makes changes to
its program requirements that affect the certificationof customers, UL Solutions shall:• Specify an effective date for the changes that shall allow
sufficient time for customers to amend their quality system.
• Formally notify all customers affected by the newrequirements of the effective date of the change andnew action required of them.
• Where appropriate, afford the opportunity for customers
to submit comments on the proposed changes.

5.5
The customer shall take any required action by the
specified effective date. If the agreed action is not foundto be acceptable, certificate suspension or withdrawal
may occur (see Section 6.7). If a special audit of thesystem is necessary to evaluate the customer’s system
due to the revised requirements, the customer shallbe responsible for the cost of the evaluation.

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6.0 UL Solutions medical regulatory services
6.1 Prior to the on-site visit:
6.1.1 UL Solutions shall provide the customer notificationof an audit, which advises scheduled dates, assigned Audit
team and cost details for the audit. Any concerns regardingor significant changes impacting the audit arrangements
must be raised to UL Solutions within two weeks of anaudit notification; otherwise, UL Solutions will proceed tobook the arrangements as specified. Customers requiring apurchase order for invoicing should also provide a purchaseorder document in response to an audit notification.
6.1.2 If there are significant changes, the customer shallprovide information to UL Solutions about those changes
by completing the Manufacturer’s Significant Change
Form (ULID-000717) (see Section 4.2.3) and responding to
the questions listed in the audit notification for planning
the audit. Upon receipt of information concerning thechange, UL Solutions shall evaluate and confirm any
adjustment to the scheduled activity. Any applicable

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forms must be completed and returned to UL Solutions
prior to commencement of the scheduled on-site visit.
6.1.3 The customer shall accept any quote for the audit,
which may include additional costs to verify changes
that have been communicated by the customer.
6.1.4 UL Solutions shall provide confirmation of the audit
arrangements to the customer concerning the finalized
visit dates and name(s) of the assigned Audit team.
Background information may be provided for each memberof the Audit team upon request.
6.2 Audits
6.2.1 Pre-assessment audit, i.e., gap assessment:
A pre-assessment audit of each facility can be performedin accordance with the requirements of the program.
At the conclusion of the evaluation, the UL Solutions
representative(s) shall summarize the audit results and provide
the facility representatives with a report of the Audit team’s
findings/gaps. In this report, UL Solutions will not draw any

conclusions as to the eligibility of the evaluated facility
for certification under UL Solutions’ certification programs.
The number of pre-assessment audits conducted at one
facility may not exceed two. UL Solutions cannot offer preassessment audits for customers with existing certifications.
6.2.2 Pre-audit planning
UL Solutions representatives shall enhance a customer’s
understanding of the QMS standard and explain themechanics and structure of the certification program.
Discussions may include topics such as global quality
standardization activities and the advantages provided by
UL Solutions accreditations. Other customer-specifictopics such as certificate scope, selection of facilities
to be registered, organizational structure and proposedschedules for audit can also be discussed.

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6.2.3 Certification audit activity
The certification audit activity is scheduled when a facility
is determined to be eligible for audit. The certification audit
activity is conducted in two stages:• Stage 1 Readiness Audit – Allows the UL Solutions
Audit team to evaluate the customer’s readiness andpreparedness for the Stage 2 Certification Audit; theUL Solutions Audit team shall also obtain information
regarding the scope of the subject QMS, site operations,processes, regulatory requirements and associated risks
to provide a focus for planning for the Stage 2 Certification
Audit, including allocation of resources. Depending on thecomplexity of the QMS, the Stage 1 Readiness Audit may be
conducted on site or off site. However, the customer may
elect to have the Stage 1 Readiness Audit conducted on site.
• Stage 2 Certification Audit – The UL Solutions Audit
team shall evaluate the effective implementation of thesubject QMS. The Stage 2 Certification Audit shall cover
all processes included in the scope of the QMS andshall be conducted at the customer’s site(s). The Stage 2
Certification Audit must be conducted within six monthsof the completion of the Stage 1 Readiness Audit for theconclusions of the Stage 1 Readiness Audit to remain valid.
Certification cannot be granted with open major
nonconformities. A full re-audit of the affected areas
will be required before certification can be granted.

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6.2.4 Surveillance audit
A surveillance audit shall assess key processes of thesubject QMS to provide confidence to the UL Solutions
Audit team that the QMS continues to fulfill requirements andobjectives. Surveillance audits are conducted on a biannual
or annual frequency. The lead auditor may recommend thatthe customer be placed on biannual visits based on several
factors including type and number of nonconformities andimmature QMS. The first annual surveillance audit following
certification shall be conducted within 12 months of the last
day of the Stage 2 Certification Audit. The second annual
surveillance audit shall be performed approximately 12months thereafter. For customers on biannual surveillance,
audits shall be conducted approximately every six months.
6.2.5 Recertification audit
Recertification shall include the continued performanceof the entire QMS over the previous cycle of surveillance
audits and examine its continued ability to meet the certificate
scope. Recertification audits shall be conducted at thecustomer’s site(s) on a three-year cycle. Recertification audits
are planned sufficiently in advance (usually three months
prior to the certificate expiry date) to enable recertification
to occur without interruption of the customer’s certification.
6.2.6 Special audit
A special audit is an additional evaluation to determine
continued conformance to findings against requirementsthat were determined to be significant and that required

corrective action. An audit team shall be scheduled
to perform a special audit in addition to the regularscheduled surveillance audits to verify the implementationof major corrective actions. Clauses audited during a
special audit shall be determined based on the audit
finding, field data, complaints, customer requests,
major organizational or system changes, etc. Special
audits may not be considered as part of surveillance orrecertification audits or for deferment of such audits.
6.2.7 Scope expansion audits
A scope expansion audit is scheduled when a UL Solutions
customer requests to expand their certificate scope toinclude other standards, operations, etc., or to assess achange of physical location. Scope expansion audits
can be scheduled in conjunction with a surveillance audit
or separate from the surveillance audit schedule. A scope
expansion audit normally results in additional audit time.
6.2.8 Alternate audit types
During extraordinary circumstances and/or wheretravel is restricted (which can include individual
auditor restrictions to travel), UL Solutions may deliver
the audit remotely or semi-remotely (as a hybridor blended audit). All deviations from normal audit
processes must be approved by UL Solutions.

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6.3 Nonconformities
6.3.1 Nonconformities fall under two categories: major
and minor. UL Solutions uses definitions for major and minor
nonconformities adopted from the Global Harmonization
Task Force. For MDSAP nonconformities, see Section 4.3.4.

• The existence of products that clearly do not comply
with the customer’s specifications and/or the regulatory
requirements due to defective elements in the quality system• Failure to inform UL Solutions of significant
changes (see Section 4.2.3)

A major nonconformity is:• Repeated nonconformities from previous audits• Any unjustifiable exclusion or failure to address
an applicable requirement in the medical device
regulations such as the Medical Devices Directive or
In Vitro Diagnostic Devices Directive, Medical Devices

6.3.2 Major nonconformities, MDSAP Grade 5 and multiple
MDSAP Grade 4 nonconformities must be responded to within
fifteen (15) calendar days from the last day of the audit where
the nonconformity was raised.

Regulation or In Vitro Diagnostic Devices Regulation• Failure to implement an applicable elementof the quality systems standard• An excessive number of minor nonconformities against
an element of the regulatory requirements for quality
systems that indicates a trend or absence of control• Failure to implement appropriate corrective andpreventative action when an investigation of postmarket data indicates a pattern of product defects• Products that are put onto the market that cause
undue risk to patients and/or users when the device
is used according to the customer’s instructions

UL.com/Solutions• A major nonconformity will result in a special audit toverify effective implementation of the corrective actions.
The special audit must be completed within ninety (90) daysof the last day of the audit where the major MDSAP Grade
5 or multiple MDSAP Grade 4 nonconformities were raised.
• The major nonconformity must be resolved prior to theissuance or re-issuance of the applicable certificate(s).
• Following the review of the major nonconformity
and the customer’s response, the reviewer will provide
a letter notification for the special audit. A quote will
be issued for the special audit to cover the time needed
to review the information and records required to closeout the nonconformity. The special audit may be
conducted remotely.

• Customers must provide evidence to UL Solutionsof implementation of the remediation actions toaddress the major nonconformity within thirty (30)
calendar days of the last day of the audit.

• Evidence of implementation of the remediation
actions to address MDSAP Grade 4 and/or Grade 5
nonconformities must be provided to UL Solutions within
thirty (30) calendar days of the last day of the audit.
6.3.3 Minor nonconformities are defined as
quality system nonconformities that judgment
and experience indicate are not likely to:• Result in the failure of the quality system• Reduce the quality system’s ability toassure controlled processes• Result in the probable shipmentof nonconforming product6.3.4 Minor nonconformities must be responded
to within fifteen (15) calendar days of the last day of
the audit where the nonconformity was raised.
6.3.5 All minor nonconformities must be resolved withinsixty (60) calendar days of issuance. Customers must
provide to UL Solutions evidence of the implementation of
the corrections and corrective actions within 60 calendar
days of issuance. UL Solutions will initiate a cost limit

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increase to the audit project to cover the time to conduct
the evaluation of the evidence submitted. The amountof time to be quoted for this project will depend on thenumber and nature of the nonconformities raised.
6.4 Conformity assessments (UKCA)
These will be conducted in line with the relevant regulations.
6.5 Issuing certifications
6.5.1 At the completion of each audit, the UL Solutions Audit
team shall provide the customer’s management representativewith any nonconformities or itemized discrepancies identified
during the audit. Time limits for responses to nonconformities
are determined by UL Solutions. The Audit team shall also
provide a recommendation as to the customer’s eligibility
for certification, continued certification or recertification.
6.5.2 The Audit team’s recommendation, provided at theend of the audit, and the entire audit package are subject toreview for the certification decision. Upon concurrence of
the Audit team and reviewers, the audit result and certification
decision shall be finalized. An appeals process is available
to the customer should there be a disagreement with thecertification decision.
6.5.3 Certification is granted only if the facility evaluatedfully complies with the requirements of the selected standard.
The management representative must respond to any

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nonconformities generated during the audit directly to
the UL Solutions auditor. If the nonconformities are notsatisfactorily resolved, UL Solutions shall provide an
explanation of the reasons why the response did not
resolve the nonconformity.
6.5.4 When certification is granted, UL Solutions shallissue an electronic certificate to the customer indicatingthat the customer’s quality system complies with a given
QMS standard for a specific group of products and/or
services and recognizing the customer’s certification witha validity not to exceed three (3) years. The certificate
information shall also be published in UL Solutions’
online certification directory, Product iQ.
6.5.5 When UKCA conformity is verified, a certificate
of conformance to the relevant part of UK MDR 2002
(as amended) is issued to the customer, with a validity
not to exceed five (5) years.
6.6 Maintenance of certification
6.6.1 Upon initial issuance of a certificate, a program ofsurveillance audits is established. The establishment andmaintenance of certification is contingent upon the continued
adherence to the terms and conditions of this document by
the customer. During these visits, UL Solutions shall verify
that the customer continues to comply with the requirementsof the subject QMS standard(s), other relevant program
standards as applicable and these program requirements.

6.6.2 Surveillance audit visits are conducted annually.
Annual surveillance audit(s) will cover approximately
one-third to one-half of the QMS. A recertification audit
covering all clauses of the applicable standard(s) is conducted
every third year as part of an ongoing program designed tomaintain the customer’s certificate. The recertification audit
duration will be approximately two-thirds of the time required
for a Stage 2 Certification Audit.
6.6.3 Alternate audit methods may be used only when
specifically authorized by UL Solutions in writing or
where there are special or extraordinary circumstances
beyond UL Solutions’ or the customer’s control.
6.7 Suspension or withdrawal of certificates
6.7.1 Certificates may be suspended by UL Solutions
under any of the following conditions:• The customer’s quality system no longer complies
with the requirements of the applicable QMS standard
or program requirements.
• The customer’s use of any UL Solutions symbol,
marking or statement is determined by UL Solutions
as unacceptable or misleading.
• The customer’s use of any accreditation body’s marking,symbol or statement is determined by UL Solutions and/or
the accreditation body as unacceptable or misleading.

Client/Customer Support Guidance-ULID-000703 – 17.0 | 19• The customer is delinquent in payments.
• The customer violates a signed UL Solutions agreement
during the process of (or after) achieving registration.
• The customer has exhibited a lack of commitment to
responding to nonconformities (action requests), including
continued failure to provide adequate root cause analysis,or continues to fail to meet agreed response dates.
• The customer delays or refuses the scheduling of
an audit, including delays in audit cost acceptance.
• The customer’s management system continues
to demonstrate an ineffective QMS by repetitive
nonconformities (action requests) being issued
and not resolved.
• The customer refuses to allow access to UL Solutions
auditors or accreditation body observers, regulatory
body observers or other UL Solutions observers
for scheduled or unannounced audits.
• The corrective action to address minor nonconformities
is not submitted to UL Solutions within sixty (60) calendar
days or is not sufficient to address the nonconformity.
• The remediation action for any MDSAP Grade 4
and/or Grade 5 nonconformities is not submitted to
UL Solutions within thirty (30) calendar days of the last
day or is not sufficient to address the nonconformity.

UL.com/Solutions• The quote for the supplemental project toreview the evidence submitted to correct thenonconformities is not accepted by the customer
and thus the nonconformities cannot be closed.

6.7.5 Certificates shall be discontinued for any quality
system or goods or services that, for any reason, areno longer eligible for certification.

6.7.2 While the suspension is in effect, the customer’s
certification is invalid. The customer shall refrain fromany further promotion of its certification and the UL
Solutions Management System Promotional Badge.

by signed agreements, UL Solutions shall take one or bothof the following actions:6.7.3 The customer shall resolve any issues surrounding
certificate suspension within a period of less thanninety (90) days. If the issues have not been resolved
within this time frame, UL Solutions shall withdraw thecertificate(s). The customer may also request withdrawalof certificate(s) at any time, subject to any notice period
contained in this document or other agreements.
6.7.4 UL Solutions may reduce the certificate scope
to exclude parts, services or sites that consistently
fail to meet the certification requirements for theapplicable parts of the certificate scope. UL Solutions
shall update its certification directory and certification
documents. The customer shall amend advertising andpromotional material to remove references to UL Solutions
certification or use the UL Solutions Management
System Promotional Badge only for products or services
covered by the reduced scope of certification.

6.7.6 Upon withdrawal of any rights or authority conferred• UL Solutions shall discontinue in whole or inpart UL Solutions-issued certificates of the quality
system and any goods or services covered.
• The UL Solutions representative shall have the rightto acquire possession of any written material utilizing
the UL Solutions certificate, UL Mark or badge, and anyother form or reference to UL Solutions used in connection
with any system, goods or services that are no longer
subject to registration.
6.7.7 Upon the termination or withdrawal of the certificate,
the customer shall immediately discontinue the use of the
UL Solutions Management System Promotional Badge andany reference to UL Solutions as its certification body,
including all materials that refer to certification status withUL Solutions. This does not in any way limit the actions thatUL Solutions may take in the event of the termination of
any rights or authority conferred by signed agreements.

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6.7.8 In the event of certificate suspension or withdrawal,
UL Solutions shall update the certificate informationin UL Solutions’ certification directory, Product iQ.

(30) days. If a complainant wishes to remain anonymousand does not request a response, the complaint is stillevaluated and considered for possible corrective actions.

6.8 Complaints

6.8.6 UL Solutions personnel handling complaints gather
and verify all necessary information to validate thecomplaint and conduct a thorough review of the facts
and information acquired from all available sources.

6.8.1 Customers are encouraged to provide feedback
concerning their experience with UL Solutions services
by completing the Customer Experience Survey and/or
emailing Inform.Regulatory@UL.com and/or emailing
CustomerAdvocacy@UL.com. See also Customer
Confidentiality and Complaint Process FAQ | UL Solutions.
6.8.2 Any complaints are requested to be submitted
in writing and should include specific references, asapplicable, for investigation, validation, documentation and
UL Solutions’ consideration for continuous improvement.
6.8.3 Submission, investigation and decisions madeconcerning any complaints shall not result in any
discriminatory actions against the complainant.
6.8.4 All complaints received are entered into
UL Solutions’ complaint database by our Customer
Advocacy team for tracking investigation and resolution.
6.8.5 Where possible, complaints are acknowledged within
forty-eight (48) hours, with updates and results communicatedto the complainant and, where possible, resolved within thattime frame. If additional time is required, this is explained
to the complainant and should not exceed thirty

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6.8.7 Decisions regarding complaints are made by orreviewed and approved by UL Solutions personnel notpreviously involved in the subject of the complaint
and are based on the facts and information collected,
also taking into consideration the resolutions andactions resulting from any prior similar situations.
6.8.8 Where possible, UL Solutions shall provide formal
notice of the closure of the complaint-handling process
to the complainant.
• If the complaint is determined to be invalid,
UL Solutions shall communicate the resultsof the investigation to the complainant.
• If the complaint is determined to be valid, UL Solutions
shall investigate for correction and corrective action.
• The results of the investigation and the corrective
action plan are to be communicated to the complainant,including determining (with the customer andcomplainant) whether and to what extent the subject of
the complaint and resolution shall be made public.

6.8.9 Upon resolution, the Customer Advocacy team
and/or the individual(s) assigned to handling the complaint
will communicate the actions taken to the complainant
within the bounds of confidentiality as described
more specifically below. Copies of documentation
addressing the complaint and its resolution are included
within UL Solutions’ corrective action system.
6.8.10 If the complainant is not satisifed with the resultsof the investigation and UL Solutions’ corrective or
preventive actions, and UL Solutions cannot come to anagreeable solution with the complainant, UL Solutions
shall inform the complainant of their right to make theircomplaint to a higher UL Solutions management level.
6.8.11 The complainant may request information on theconsideration of the complaint or on any corrective action
at any time.
6.9 Complaints about UL Solutions certified customers
6.9.1 If UL Solutions receives a complaint about acertified customer, the confidentiality of the customer’s
files and any other associated information must be
maintained in accordance with UL Solutions policy
and the signed agreement with the customer.
6.9.2 If UL Solutions receives a complaint by a certified
customer’s end customer about the customer, the complaint
shall be communicated to the customer if agreeable
to the end customer and depending on the significanceand impact on the system.
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6.9.3 Only complainants who are willing to identify
themselves to the UL Solutions certified customer will
be made aware of their complaint’s resolution, i.e., theresolution would be communicated by the UL Solutions
customer during resolution. UL Solutions shall encourage
its certified customer to work with the complainant throughtheir quality system’s complaint handling mechanism toresolve the issue. UL Solutions can follow up during thesubsequent routine surveillance audit(s) by evaluating
the certified customer’s resolution of the complaint.
6.9.4 If the investigation into the complaint leads
UL Solutions to determine that further investigationis necessary, yet without an on-site visit, it shall be
requested that the certified customer provide a
corrective action plan including root cause analysis,planned actions and timing.
6.9. If UL Solutions determines after review of thecomplaint and any other associated evidence that an
on-site visit is required, the following shall be observed:• Depending on the severity of the complaint, certain
elements/systems may have to be evaluated at
the next surveillance audit, or an immediate auditof the subscriber may need to be scheduled.

UL.com/Solutions• If a major nonconformity is found during the assessmentof the complaint, it is to be documented in the audit
report and a response by the customer shall be
required within 10 days of the last day of the audit.
6.9.6 UL Solutions shall provide monthly progress
reports to the complainant should the process takemore than one month to conclude. The complainant
may also enquire at any time the status of the complaint.
However, UL Solutions shall not release any confidential
information regarding the UL Solutions certified
customer unless otherwise stated in the document.
6.9.7 UL Solutions shall determine, together with thecertified customer and the complainant, whether
and, if so, to what extent the subject of the complaint
and its resolution shall be made public.
6.10 Disputes and appeals
6.10.1 Customers may dispute the issuance or classificationof any nonconformity issued by the UL Solutions Audit team.
Any dispute shall be raised with the lead auditor of the Audit
team first. If the customer is not satisfied, the dispute can beraised with a UL Solutions certification decision maker for
further review and decision. If an agreement still cannot bereached and the nonconformity will likely result in registration
withdrawal, the customer is invited to make a formal appeal.

6.10.2 Disputes should be submitted in English byemail or other written means to the lead auditor of the
Audit team for forwarding to a regional certification
decision maker. The disputes must be submitted
within the allowable time frame for response to thenonconformity as per Sections 6.3.2 and 6.3.4 above.
6.10.3 The UL Solutions certification decision makershall confirm receipt of the dispute. While the disputeis being assessed, no further action by the customer isrequired with regards to that specific nonconformity.
6.10.4 Appeals are generally not complaints. An appeal ismade when there is a disagreement with a UL Solutions
decision to not grant or to withdraw registration.
6.10.5 Appeals should be documented by the customer
and submitted in English to UL Solutions on company
letterhead with the signature of an executive officer.
The appeal must provide full details to support theoverturning of a recommendation not to grant or towithdraw registration. Appeals must be made within thirty(30) days of the audit where certification was refused orwithin 30 days of the notice of certification withdrawal.

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6.10.6 Upon receipt of the appeal, UL Solutions’ leadreviewer shall acknowledge their receipt of the appeal tothe appellant. An appeals panel shall then be convened
to assess the validity of the recommendation not to grantor to withdraw registration. The appeals panel shall include
additional UL Solutions auditors independent of boththe audit recommendation and the review of the audit
where a recommendation not to grant or to withdraw
registration was made.
6.10.7 Once an appeals panel is formed, it shall be verified
with the appellant to ensure that they have no objection to thecomposition of the panel. The appellant may state objections
to the composition of the appeals panel. Consequently,
the constitution of the panel may be amended accordingly
to resolve those objections. Once both sides agree to thecomposition of the panel, both UL Solutions and the appellant
agree to abide by the decision formed by the appeals panel.
6.10.8 The chair of the appeals panel shall verify that all
facts are equally presented to the individual UL Solutions
auditors on the appeals panel. Each UL Solutions
auditor shall be requested to independently weigh thecustomer’s appeal with records generated from theaudit. Additional requests for information from either
the UL Solutions Audit team or the customer shall be
requested through the chair of the appeals panel.

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6.10.9 The UL Solutions auditors shall be asked to maketheir decision in writing and to document their rationale.
The chair of the panel shall ensure that the decisions reached
are consistent with the facts as presented by the customer.
6.10.10 A majority decision of the panel assessors shallbe carried forth as the final decision of the panel.
6.10.11 The appellant may request of UL Solutions’ leadreviewer the status of any application at any time during
the appeals process or in relation to UL Solutions’corrective action, should the appeal be successful.
6.10.12 UL Solutions’ lead reviewer will provide in writing
the decision and reasoning of the panel’s final decision
to the appellant. The final decision shall be provided
within 45 days of the receipt of the written appeal.
6.10.13 The appellant is at liberty to bring the handlingof their concern to the attention of an accreditationbody if they believe the appeal has not been handledin accordance with UL Solutions’ medical regulatory
services program requirements.
6.10.14 UL Solutions shall ensure that no discriminatory
action is taken against a customer in any way for thesubmission of a dispute, appeal or complaint.

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7.0 UL Solutions’ regulatory programs
7.1 Medical Devices Single Audit Program
7.1.1 UL Solutions provides registration to ISO 13485:2016
and the MDSAP, as administered by the MDSAP regulatory
authorities (RA).
7.1.2 UL Solutions shall evaluate and register customers
to the requirements of the ISO 13485:2016 standard
and MDSAP requirements.
7.1.3 In addition to Section 4.1.15 of this document,
as a condition of registration under the MDSAP, thecustomer agrees to allow UL Solutions’ Audit team tobe observed by representatives from the MDSAP RAs
during the on-site audit at the customer’s location(s).
7.1.4 As a condition of registration under the MDSAP,
the customer agrees to allow UL Solutions to releaseto the MDSAP RAs any document that the RAs consider
necessary to determine a medical device customer’s
conformance to ISO 13485 requirements andapplicable regulations of the MDSAP member countries.

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These documents would include those that UL Solutions
or its auditors use to plan, perform or follow up on an
ISO 13485/MDSAP investigation and to record observations
or report results of an ISO 13485 QMS audit. All documents
held by RAs shall be treated in accordance with appropriate
regulations and guidelines dealing with confidential andproprietary information. The documents required will be
uploaded to the MDSAP REPS database as required under
the MDSAP to facilitate access for the participating RAs.
7.1.5 UL Solutions shall notify RAs in writing of any
change in a customer’s registration certificate status

relating to extension or reduction of scope, suspension
or withdrawal of that certificate.

7.1.6 UL Solutions shall publish a list of customers
registered by UL Solutions under the MDSAP withthe customer’s address and scope of registration in
UL Solutions’ certification directory, Product iQ.

7.2 UKCA program
7.2.1 U.K./MHRA registration:
Customers wishing to place a device on the
Great Britain market must register with the MHRA.
All medical devices, including in vitro diagnostic(IVD) devices, custom-made devices and systems orprocedure packs must be registered with the MHRA
before being placed on the Great Britain market.
Where a customer is not established in the U.K.,
they must appoint a UK Responsible Person(UKRP) to register and act on their behalf.
The UKRP acts on behalf of the non-U.K. customer
to carry out specified tasks in relation to thecustomer’s obligations. This includes registering thecustomer’s devices with the MHRA before the devices
can be placed on the Great Britain market.

7.1.7 Apart from appearing on the issued certificate,
the MDSAP logo may not be used elsewhere.

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7.2.2 Post-market surveillance and vigilance:
For medical devices (including self-declared devices)
placed on the U.K. market, the customer is required
to submit vigilance reports to the MHRA (and the
U.K. approved body if a certificate is issued) whenincidents occur in the U.K. that involve their device.
7.2.3 Labelling requirements:
Medical devices placed on the Great Britain market musthave a UKCA marking (or a CE marking, depending on
which legislation the device has been certified under).
Where relevant, the number of the approved body(or notified body) must also appear on the label.
Devices can have both the CE and UKCA markings present
on the labelling. However, the name and address of the
UKRP, where applicable, needs to be included on productlabelling, the outer packaging or the instructions foruse in cases where the UKCA marking has been affixed(including when devices have been dual-marked).

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Appendix A — Conditions for use of an accreditation body markA.1 Requirements for use of the UKAS markA.1.1 This section applies only to those customers
with written authorization from UL Solutions to
use the UKAS mark as evidenced by the UKAS
mark on their certificate of registration.
A.1.2 Only customers authorized to use the UKAS markare entitled to use the mark illustrated here.
A.1.3 Use of the UKAS mark must always be in conjunction
with UL Solutions’ relevant accreditation number: 4426.
A.1.4 The UKAS mark may be used on stationery and publicity
material or other items relevant to the customer’s ISO
certificate(s) in connection with those goods and/or
services listed on the certificate(s). Publicity material
shall not include notices, labels, documents or written
announcements affixed to or otherwise appearing on
goods or products unless the goods or products have been
manufactured under an accredited product conformity
scheme. This restriction shall also apply to primary
packaging, e.g., blister packs, and promotional products.
A.1.5 The UKAS mark shall not under any circumstances
be used directly on or closely associated with any
product, process or service in any way that may imply
that the product, process or service itself is in any way
certified or approved by UL Solutions or UKAS.

A.1.6 Accreditation marks shall not be used in such a way to
imply that UKAS accepts responsibility for activities carriedout under the scope of accreditation and/or certification.

the size may be proportionately increased. Authorized users
shall ensure that the form of the accreditation mark is legible.

A.1.7 The registered customer agrees to discontinue any

reproduce it in a single color only, which should be thepredominant ink color of the document or, in the case of
preprinted letterhead paper, the predominant color of theletterhead. Embossed, relief or die-stamped versions may
be used. The marks may be reproduced as watermarks.

use of the UKAS mark and any form of statement withreference to the authority of the registered customer to
use the UKAS mark that is unacceptable to UL Solutions orthat, in the opinion of UL Solutions, might be misleading.
A.1.8 Upon the termination of registration, forwhatever reason, the customer must discontinue
all use of the UKAS mark immediately.
A.1.9 The UKAS accreditation mark shall normally havea minimum height (excluding the accreditation number)of 20 mm. Any enlargement or reduction shall retain thesame proportions as those printed in this publication. The
mark and the accreditation number shall be considered asa single entity for purposes of enlargement or reduction.
In exceptional circumstances, which are usually dictatedby reason of space limitation or cost, the marks may be
reproduced at a reduced height, provided that, irrespectiveof the height of reproduction, the mark must, in theopinion of UL Solutions, be legible, with no infilling.

A.1.11 Authorized users of the accreditation mark shall

A.1.12 The accreditation marks shall not be displayedon vehicles, except in publicity material containing
an accreditation mark as part of a larger advertisement,
provided the mark is used in the publicity material inaccordance with the conditions stated above. The accreditation
mark shall not be displayed on buildings or flags. Marks may bedisplayed on internal walls and doors and on exhibition stands.
A.1.13 The UKAS national accreditation symbol shall always
be used in conjunction with the UL Solutions Promotional
Badge and shall be enclosed in a box as indicated below.
The UL Solutions Promotional Badge may be used without
the UKAS accreditation mark in accordance with guidelines
on the UL Solutions website (see Section 3.17).

A.1.10 When printed on an unfolded portion of stationery sized
no greater than A4, the UKAS mark shall be displayed no larger
than 30 mm high. On larger portions of unfolded stationary,4426

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A.2 Requirements for use of the UKCA marking
A.2.1 The UKCA marking must be clearly visible
and legible when affixed to the product. The UKCA
marking is at least 5 mm in height.
A.2.2 If the marking is reduced or enlarged in size,
the letters forming the UKCA marking must be
in proportion to the version set out below.

A.2.3 For devices dual-marked for CE and
UKCA, the customer must ensure the legibility
and visibility of the UKCA marking.

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UL.com/Solutions© 2024 UL LLC. All rights reserved.

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