The EU MDR submission process can be complex and time-consuming. Whether you're launching a new medical device or transitioning from MDD to MDR, Elexes helps you navigate MDR 2017/745 requirements with ease. Our regulatory experts ensure your Technical Documentation, Clinical Evaluation, Risk Management, and PMS plans align with EU expectations, paving a smooth path to CE marking.
With Elexes, you’ll get:
⦿ Gap analysis and regulatory strategy tailored to your device
⦿ Hands-on support with documentation preparation and updates
⦿ Communication with Notified Bodies and Authorized Representatives
⦿ Full lifecycle support post-submission
Start your EU compliance journey with a trusted MDR consulting partner.
Elexes is a global regulatory consulting firm with a proven track record in helping manufacturers secure CE marking through EU MDR submissions. Our team comprises ex-regulators, engineers, and quality professionals who understand the expectations of Notified Bodies.
We’ve helped both startups and established companies successfully complete:
⦿ First-time MDR submissions
⦿ Legacy device transitions from MDD to MDR
⦿ Class I to Class III device submissions
⦿ MDR Clinical Evaluation Report (CER) and Performance Evaluation Report (PER) support
Our support spans Class I, IIa, IIb, and III devices and includes robust preparation for audits and NB reviews.
Explore how we supported Medical Device Clinical Evaluation Report documentation for EU MDR compliance.
Our streamlined approach to EU MDR submission support ensures each step is aligned with EU regulatory expectations. Here's how we help:
Regulatory Assessment
We determine your device classification and applicable MDR annexes (Annex IX, X, XI).
Technical Documentation Preparation
We build or review your Technical File per Annex II and III, including design verification, risk management, labeling, and more.
Clinical Evaluation & PMS
Our team prepares high-quality Clinical Evaluation Reports (CERs) and Post-Market Surveillance (PMS) plans that meet MDCG and MEDDEV guidance.
Notified Body Communication
We assist in submission, response to queries, and follow-ups with Notified Bodies.
Post-Certification Support
Ongoing support with vigilance, periodic safety update reports (PSURs), and PMS updates.
Your success is our priority, from submission to sustained market presence.
Free MDR Submission Checklist for Medical Device Manufacturers
Cut through the regulatory noise with this actionable, easy-to-follow checklist designed by our MDR experts.
⦿ Covers documentation, clinical evaluation, labeling, PMS, and more
⦿ Ideal for both first-time submissions and MDD-to-MDR transitions
An MDR submission refers to the process of submitting documentation and evidence to demonstrate compliance with the EU Medical Device Regulation (MDR 2017/745 technical documentation) to obtain CE marking under MDR for a medical device.
Depending on the device class and documentation readiness, MDR submissions can take 6–12 months, especially if Notified Body involvement is required.
Any manufacturer wishing to market a medical device in the EU must submit under MDR 2017/745 unless the device qualifies for a different regulation like IVDR.
Our process begins with an in-depth consultation where we learn about your medical device, its intended use, and your specific goals. This helps us tailor our assessment to your unique needs.
Our team of experts is well-versed in global medical device regulations, including FDA submissions, CE marking, TGA requirement, Health Canada approvals, ISO, and more. We stay up-to-date with the latest changes in the regulatory landscape.
We will conduct a comprehensive review of your existing documentation, including design files, clinical data, quality management systems, and risk assessments.
Our consultants will perform a gap analysis to identify any areas where your device may fall short of compliance. This forms the basis for our recommendations.
Based on our findings, we will provide you with detailed recommendations and a roadmap for achieving compliance. This may involve revising documentation, conducting additional testing, or making necessary design changes.
Our services don't stop with just the assessment. We offer ongoing support to guide you through the compliance process, helping you address any challenges that may arise.
Elexes offers a globally recognized ISO 13485 certification consultant who is renowned to enhancing your business credibility in the medical devices industry.
Our presence across the globe ensures audits are conducted by local-language auditors, facilitating clear communication and understanding.
Our experts provide guidance and consultants to help you adhere to necessary regulations, ensuring your products meet all legal requirements and is compliant to all necessary standards.
At Elexes, we offer to assist in securing additional local certifications, enabling you to manufacture and sell medical devices in various markets across the globe.
We offer complete confidentiality to all our clients which makes us one of the most trusted regulatory and quality compliance consulting.
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 -
CEO Masterlink, Arizona
CEO Novasignal, Los Angeles
President ViDava, Florida
Sr. Exe Treedental, Hong Kong
Manager Outset Medical, California
CTO Jana Care, Massachusetts
MD Blackrock Pharma, England
VP Regulatory AliveCor, California
Owner Liz Inc., Arizona
CEO Radformation, New York
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