Team Elexes 
Need help with CE marking for your product? Contact Elexes today for a free consultation!
Comprehensive CE Marking Services for EU Compliance
If you're looking to launch your product in the European market, obtaining the CE mark is your first crucial step. At Elexes, we offer end-to-end CE marking services tailored to medical devices, in-vitro diagnostics (IVDs), SaMDs, and more. With a team of EU regulatory experts, we streamline your product’s path to EU compliance, saving you time, resources, and unnecessary rework.
Whether you're a startup launching your first device or a global enterprise seeking re-certification under EU MDR/IVDR, we ensure your product meets all applicable directives and regulations to lawfully bear the CE mark.
If your product falls under the medical device regulation, our EU MDR consulting services can help you ensure seamless CE compliance.
Why CE Marking Matters
The CE mark is more than just a label—it signifies that your product complies with EU health, safety, and environmental protection legislation. It is mandatory for numerous products to be legally sold in the European Economic Area (EEA), and also enhances global marketability and consumer trust.
CE marking is particularly critical for:
⦿ Medical Devices (Class I, IIa, IIb, III)
⦿ In-Vitro Diagnostics (per EU IVDR)
⦿ Consumer electronics and machinery
⦿ Personal protective equipment (PPE)
Our CE Marking Services
Regulatory Strategy & EU Compliance Assessment
We evaluate your product category and offer a personalized roadmap based on the applicable EU directives or regulations (such as MDR 2017/745 or IVDR 2017/746).
Technical Documentation & File Preparation
Our team develops and/or reviews your Technical File or Design Dossier, ensuring it meets the requirements under Annexes of relevant CE directives.
Clinical Evaluation & Performance Evaluation
For medical and IVD devices, we help draft or review Clinical Evaluation Reports (CERs) and Performance Evaluation Reports (PERs) in line with MDCG guidance.
Notified Body Support
We guide you in selecting the right Notified Body, manage communications, and help you respond to their feedback during conformity assessment procedures.
Declaration of Conformity & Labeling Review
We draft or review your EU Declaration of Conformity and validate product labeling and Instructions for Use (IFUs) for EU compliance.
Post-Market Surveillance & Vigilance Support
Elexes supports Post-Market Surveillance (PMS) Plans, Periodic Safety Update Reports (PSURs), and trend reporting, essential under MDR and IVDR.
Who Needs CE Certification?
Our CE marking services are ideal for:
⦿ Manufacturers seeking EU market entry
⦿ OEMs and private labelers with EU distribution plans
⦿ Companies needing to transition from AIMDD/MDD/IVDD to MDR/IVDR
⦿ Organizations looking to maintain ongoing CE compliance
CE Marking – Your Gateway to the European Market
CE marking is not just a one-time exercise—it’s a lifecycle commitment. From the initial gap analysis to post-market compliance, Elexes stays by your side at every phase of the process and all this at very affordable pricing and offerings.
FAQs
Frequently Asked Questions!
CE marking indicates that a product complies with EU safety, health, and environmental protection requirements.
Manufacturers aiming to sell products within the European Economic Area (EEA) require CE marking to demonstrate compliance.
Elexes provides end-to-end support, including regulatory strategy, technical documentation, and liaison with Notified Bodies.
Compliance Assurance
Stay compliant with industry regulations and standards.
Cost-effective
Achieve regulatory success with Elexes, all within your budget.
Why choose
Elexes for medical device regulatory & compliance services?
Quick Turn around
Experience timely results with our efficient services.
Confidentiality guaranteed
We offer 100% confidentiality understanding how critical the data is for you.
Elexes offer complete range of regulatory and compliance expertise, ensuring full-support in product development and post-market compliance. Get everything under one roof for your medical device!
Our New Product Approval Service Corner
We offer different services that will help you not only keep your product well in boundaries of regulations but also speed up the entire approval process. Some of these services are -
Associated Regulatory Authorities.
We’ve More
Than 256+ Global
Clients
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Clients Testimonials
Amazing Feedback About Our Services
Tom Birney
CEO Masterlink, Arizona
“
Elexes gave us immense support. Their Knowledge and thoroughness were excellent. I look for all of these qualities in consulting firms
“
Diane Bryant
CEO Novasignal, Los Angeles
“Prompt and competent! Elexes should be your next regulatory consultant. Their timeline-based project plan expedited the process.
“
Daniel Kinsey
President ViDava, Florida
“Professional and easy to work with! They expedited CE Marking for our products and also created clinical evaluations, risk assessments, and provided testing/manufacturing advice.
“
Linda Pan
Sr. Exe Treedental, Hong Kong
“Having Elexes as our import-export expert was a great choice. Elexes' team answered all our questions and guided us through every step.
“
Joshua Mink
Manager Outset Medical, California
“Highly recommend Elexes! They always meet commitments and follow through on action items.
“
Michal Depa
CTO Jana Care, Massachusetts
“Highly recommended! They excelled at regulatory projects, and document control, and grasped our product's nuances quickly.
“
Philip McFerran
MD Blackrock Pharma, England
“Kudos to the Elexes team! They're always proactive and have provided invaluable support to us with import, labels, and registrations.
“
Samip Shah
VP Regulatory AliveCor, California
“Excellent communication, diligent work. There is a strong quality background and QMS norms expertise.
“
Elizabeth W
Owner Liz Inc., Arizona
“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.
“
Kurt Sysock
CEO Radformation, New York
“Elexes is a go-to for all FDA regulatory and quality systems work. They outperformed every expectation!
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