Service
A faster, cost-efficient route to placing your medical device on the European and UK market - without the cost or timeline of full UL/CB certification.
Designed for medical device manufacturers whose primary market is Europe and the UK, this service delivers the safety test evidence you need to support EU/UK market access – without the time, cost or scope of a full UL Mark or CB Scheme certification.
Not every medical device manufacturer targets markets outside Europe. As certification is not required to sell into the EU or UK, following the full UL Mark Certification or CB Certification process can be costlier and slower than your go-to-market plan would require. Test Evidence for EU Market Access closes that gap – giving you accredited, defensible safety evidence aligned to your real commercial needs.
This service is the right fit when:
Test Evidence for EU Market Access is an informative test report issued against the relevant EN/IEC safety standard for your medical device or laboratory equipment (for example EN/IEC 60601-1 or EN/IEC 61010-1 and its applicable collateral and particular standards). The report can be issued as an ILAC 17025 accredited report when the standard falls within our scope of accreditation (UKAS, ACCREDIA, IAS or equivalent).
Deliverable. An informative test report only. No certification marks are released.
Standards in scope. EN/IEC 60601-1 (medical equipment), EN/IEC 61010-1 (laboratory and measuring equipment) with support for applicable particular and collateral standards. Other safety standards are available, too.
Upgradeable. When you're ready to enter markets outside Europe, the service can be upgraded to full UL Mark Certification or CB Scheme certification or both – for an additional fee and on a case-by-case basis. We can include an additional service detailing the gaps between the evidence gathered for EU Market Access and the work required to upgrade to CB or UL Mark Certification, helping you understand the route to global compliance.
Where the standard falls within our scope, your report is issued under ILAC 17025 accreditation (UKAS, ACCREDIA, IAS or equivalent).
A global team of qualified medical device and laboratory equipment experts – from electrical safety and electromagnetic compatibility (EMC) engineers through cybersecurity and medical software experts to regulatory specialists.
Safety, EMC, cybersecurity and regulatory services – including QMS (ISO 13485), MDSAP, UKCA MDR/IVDR, and partnered CE MDR/IVDR - under one roof.
Your informative report is designed to be upgradeable to full UL/CB certification when you expand beyond Europe – supporting future certification needs.
Backed by UL Solutions' reputation for technical rigor, regulatory know-how and quality service delivery.
From quote to delivery, your project handler keeps you informed at every stage – with documented timelines for any information required during evaluation.
Successfully introducing on the market an advanced medical wearable device: Sidly case study.
Addressing the requirements of IEC 60601-1-2, 4th Edition and its amendment.
We conduct independent, rigorous testing and certification of medical products to help companies demonstrate safety and performance according to regulatory requirements and industry standards.
Evaluate compliance to IEC 60601, the standard for the basic safety and essential performance of medical electrical equipment.
Services for electrical equipment used in testing, measurement and laboratories.
Our deep expertise and extensive presence in Europe enable us to help medical device manufacturers with CE marking compliance for the EU market.
Comprehensive electromagnetic compatibility testing and certification.
EMC pre-compliance can help identify likely sources of testing failure during your product’s early design phases.
Medical CAP offers a comprehensive suite of advisory, testing and certification services to help companies manage cybersecurity risks and demonstrate a strong security posture to the marketplace.
Testing, evaluation and certification services for health and medical software to key industry standards: IEC 82304-1, IEC 60601-1 part 14 and IEC 62304.
Testing can begin earlier because we assume safety-critical components hold suitable approvals, rather than requiring full CB/UL evidence upfront. The project engineer can accept component declarations in some instances. Pricing may be lower because requirements are less stringent and the deliverable is an informative report rather than a certification. If issues are found, a findings letter accompanies the report - referencing the relevant clauses so you can address them.
All projects are different and many factors can affect device complexity, but turnaround times may be shorter than a full certification project, and we can offer additional resources to help complete projects in a timelier fashion via our Premium Service offering, should that be required.
A findings letter is issued with the summary report, explaining each test failure with the relevant clause references so you can understand the safety concern. If lack of evidence is the cause, the letter outlines what is needed to obtain a final pass. Addressing the findings may require a re-submission with an additional quote – but we do not re-test clauses that have already passed unless your design changes affect them.
Yes. The service is designed to be upgradeable. Provided the original report was issued without non-compliances; no repeat testing is typically required. Some additional work may be needed – for example, adding national deviations or re-assessing components against the more stringent certification requirements – which is quoted on a case-by-case basis. We aim to keep additional work to a minimum.
Yes, in many cases. Low Voltage Directive (LVD) products and Class I medical devices (non-measuring, non-sterile, or non-reusable surgical) — as well as Class A IVDs — may be eligible for self-declaration, depending on applicable requirements. A report containing non-compliant clauses may be used as part of a self-declaration provided that the manufacturer can justify the gaps in their Technical File. Even for products requiring Notified Body involvement, the manufacturer may address the gaps identified in the report and document how these gaps are closed in their Technical File.
Medical device manufacturers whose primary go-to-market is Europe and/or the UK, where formal certification is not required. It is also a strong fit for pre-compliance projects or for manufacturers who know their product is not yet ready for full certification but need testing evidence to support EU market access.
Interaction is streamlined to keep the service efficient and cost-effective – much of the day-to-day communication is handled by our Customer Engagement/Follow-Up team. You will still receive regular updates from your project handler on the status of testing and any items required during the project.
