EU Authorised Representative Services & CE Marking
Get expert support for EU market access with structured guidance on CE marking, technical documentation, regulatory strategy, and ongoing compliance obligations. Elexes helps medical device manufacturers reduce delays, strengthen submission readiness, and navigate EU MDR requirements with confidence from initial assessment through post-market responsibilities.
Our EU Authorised Representative Services
Comprehensive regulatory support for CE marking, EU MDR compliance, and European market access.
CE Marking Support
End-to-end support for CE marking, including classification, conformity assessment route selection, technical file review, Declaration of Conformity preparation, and Notified Body coordination.
EU MDR Documentation
Expert help structuring, authoring, and reviewing Annex II and III technical documentation, including GSPR mapping, risk management, clinical evidence, and post-market records.
Gap Assessment
Structured EU MDR gap assessments benchmark your existing documentation, quality processes, and evidence against current regulatory requirements with prioritized remediation actions.
Regulatory Strategy
Tailored EU regulatory strategy covering device classification, conformity assessment pathways, standards mapping, submission sequencing, and Notified Body engagement planning.
Clinical Evidence
Support for CER development, PMCF adequacy reviews, and clinical evidence strategy to strengthen safety and performance justification under EU MDR.
Labeling Compliance
Detailed review of labeling and IFU content for EU MDR compliance, including UDI obligations, symbol usage, language requirements, and market-ready documentation.
End-to-End Compliance
Confident EU Market Access Starts Here
Elexes helps manufacturers move from regulatory uncertainty to a defensible CE marking pathway with practical, expert-led support. From EU MDR strategy and technical documentation to gap remediation, clinical evidence, and post-market alignment, the team builds submission-ready systems that stand up to Notified Body scrutiny while reducing costly rework, delays, and compliance risk.
Trusted By Manufacturers
Success Stories
See how manufacturers strengthen compliance and accelerate market access with Elexes support.
“Excellent communication, diligent work. There is a strong quality background and QMS norms expertise.”
Samip Shah
“Professional and easy to work with! They have been instrumental in getting CE Marking for our products in the quickest way. They created clinical evaluations and risk assessment reports and provided advice on testing and manufacturing.”
Daniel Kinsey
“Accurate and amazing! Their regulatory-compliant fact sheets for multiple products enabled us to sell domestically and internationally without issues. Their work had an impressive turnaround time.”
Elizabeth W
“Highly recommended! They excelled at regulatory projects, and document control, and grasped our product’s nuances quickly.”
Michal Depa
“Excellent communication, diligent work. There is a strong quality background and QMS norms expertise.”
Samip Shah
“Professional and easy to work with! They have been instrumental in getting CE Marking for our products in the quickest way. They created clinical evaluations and risk assessment reports and provided advice on testing and manufacturing.”
Daniel Kinsey
“Accurate and amazing! Their regulatory-compliant fact sheets for multiple products enabled us to sell domestically and internationally without issues. Their work had an impressive turnaround time.”
Elizabeth W
“Highly recommended! They excelled at regulatory projects, and document control, and grasped our product’s nuances quickly.”
Michal Depa
“Excellent communication, diligent work. There is a strong quality background and QMS norms expertise.”
Samip Shah
“Professional and easy to work with! They have been instrumental in getting CE Marking for our products in the quickest way. They created clinical evaluations and risk assessment reports and provided advice on testing and manufacturing.”
Daniel Kinsey
“Accurate and amazing! Their regulatory-compliant fact sheets for multiple products enabled us to sell domestically and internationally without issues. Their work had an impressive turnaround time.”
Elizabeth W
“Highly recommended! They excelled at regulatory projects, and document control, and grasped our product’s nuances quickly.”
Michal Depa
The Elexes Difference
Why Choose Elexes?
Manufacturers rely on Elexes for disciplined regulatory execution and measurable compliance outcomes.
Deep Expertise
50+ years of collective regulatory experience across EU MDR, FDA, ISO 13485, and global frameworks.
Proven Results
250+ successful projects across 200+ product types with a 90% audit clearance rate.
End-to-End Support
From strategy and documentation to approvals, launch, and post-market compliance under one partner.
Flexible Delivery
Project-based, part-time, or embedded regulatory support without adding permanent internal headcount.
Meet The Elexes Team
Experienced specialists guiding complex regulatory pathways.
Elexes is a trusted medical device regulatory consulting partner supporting manufacturers through complex approval and compliance requirements across global markets. The company has built its reputation by helping medical device businesses prepare stronger submissions, reduce avoidable regulatory setbacks, and maintain compliance beyond initial approval. With 50+ years of collective experience, the team supports clients across CE marking, FDA, Health Canada, TGA, quality systems, and post-market obligations. Elexes has completed 250+ successful projects across 200+ product types and supports a broad mix of startups, scaling manufacturers, and established global companies. Its approach combines regulatory depth, practical execution, and transparent collaboration to help clients move from uncertainty to defensible market access.
250+ ProjectsSuccessful regulatory and compliance engagements delivered200+ Product TypesExperience across diverse medical device categories90% Audit ClearanceStrong inspection and audit readiness outcomes
Frequently Asked Questions
What does an EU Authorised Representative do?
An EU Authorised Representative acts on behalf of a non-EU medical device manufacturer for specific regulatory obligations under EU MDR. This can include maintaining required documentation availability, supporting communications with competent authorities, and helping ensure the manufacturer meets ongoing compliance responsibilities tied to CE-marked products placed on the EU market.
What is included in CE marking support?
CE marking support typically includes device classification, conformity assessment route selection, EU MDR regulatory strategy, technical documentation review or authoring, GSPR checklist support, risk management alignment, labeling review, clinical evidence planning, and preparation for Notified Body engagement. The goal is to create a complete, defensible compliance package that supports lawful EU market access.
How long does the CE marking process take?
The timeline depends on device class, documentation maturity, clinical evidence strength, and Notified Body availability. Lower-risk devices with strong existing files may move faster, while higher-risk devices often require more extensive remediation, clinical work, and review cycles. A readiness assessment early in the process helps identify gaps, set realistic milestones, and avoid preventable delays.
Do I need EU MDR technical documentation before approaching a Notified Body?
Yes, manufacturers should have well-structured technical documentation substantially prepared before formal Notified Body engagement. Reviewers expect complete and traceable evidence covering device description, GSPRs, risk management, verification and validation, clinical evaluation, labeling, and post-market planning. Incomplete files often trigger deficiencies, extra review rounds, and longer approval timelines.
Can you help if we are transitioning from MDD to EU MDR?
Yes. Transition support typically includes gap assessment against EU MDR requirements, remediation planning, technical file upgrades, CER and PMCF strengthening, labeling updates, and alignment of post-market systems. Because EU MDR expectations are broader and more rigorous than legacy MDD requirements, structured transition planning is essential to maintain market continuity and reduce compliance risk.
What documents are usually reviewed for CE marking readiness?
A readiness review commonly covers classification rationale, technical documentation, GSPR checklist, risk management file, clinical evaluation materials, verification and validation evidence, labeling and IFU, quality system alignment, and post-market surveillance records. The review checks completeness, consistency, traceability, and whether the documentation is organized to withstand Notified Body scrutiny.
Can Elexes support clinical evidence and CER development?
Yes. Elexes supports clinical evidence strategy, CER authoring and review, PMCF adequacy assessment, and alignment between clinical evidence, risk management, and GSPR compliance. This is especially important under EU MDR, where clinical justification is heavily scrutinized and weak evidence packages can delay CE marking or create major remediation burdens.
Do you provide ongoing compliance support after CE marking?
Yes. Ongoing support can include change impact assessments, complaint and PMS governance, documentation updates, labeling reviews, regulatory correspondence support, and broader RAQA operational assistance. Post-market compliance is a continuing obligation under EU MDR, so maintaining documentation and surveillance systems after certification is critical for long-term market access.
Still Need Regulatory Guidance?
Speak with our experts about your CE marking pathway.
Certified & Trusted
Awards and Recognition
ISO 13485
Medical device quality system expertise
MDSAP
Multi-market audit readiness support
IEC 62304
Software lifecycle compliance capability
