Elexes helps you achieve full EU MDR compliance faster. From documentation to notified body preparation and submissions to post-market support, you can trust our EU MDR consultants to guide your device through Europe’s complex regulatory landscape.
Whether you're a first-time entrant to the EU market or transitioning legacy devices from MDD to MDR, our expert team tailors an EU regulatory strategy for medical devices that aligns with your product, business model, and launch timeline, ensuring no missed steps and no costly delays.
Navigating the European Union Medical Device Regulation (EU MDR 2017/745) is a complex and resource-intensive process. An experienced EU MDR consultant acts as your regulatory partner—interpreting the regulation, identifying applicable requirements for your device, preparing comprehensive technical documentation, and facilitating a successful CE Mark submission via a Notified Body.
At Elexes, we provide strategic and hands-on EU MDR and IVDR consulting services for all classes of medical devices and IVDs. We help you establish compliance and achieve accelerated market entry.
You’ll benefit from Elexes’ EU MDR Consultant services if you’re:
⦿ A start-up, planning to introduce its device in the EU countries for the first time
⦿ A legacy device manufacturer, transitioning from MDD to MDR
⦿ Facing Notified Body review hurdles or needing corrective actions
⦿ An IVD developer preparing for IVDR while managing MDR expectations
⦿ A non-EU manufacturer who needs an EU Authorized Representative
Elexes has successfully supported manufacturers achieve EU MDR compliance for Class I reusable, Class IIa software, Class IIb implants, Class III drug-device combinations, amongst a wide range of device types and device classes.
Elexes offers complete, tailored regulatory support for MDR compliance. Here’s how we help:
⦿ Determining the correct device class under MDR Annex VIII
⦿ Identifying the appropriate conformity assessment route
⦿ Assessing the need for clinical investigation based on classification and claims
⦿ Developing a tailored regulatory roadmap for CE marking
⦿ Performing gap analysis against the General Safety and Performance Requirements (GSPRs)
⦿ Aligning your ISO 13485 QMS with MDR-specific processes
⦿ Recommending updates to SOPs and forms as needed
⦿ Reviewing all your current documentation against the EU MDR requirements
⦿ Supporting the integration of PMS, PMCF, and vigilance procedures into QMS
⦿ Develop PMS plans and Periodic Safety Update Reports (PSURs) based on device risk class
⦿ Design and validate procedures for Field Safety Corrective Actions (FSCAs)
⦿ Support incident investigation, reporting, and trending analyses
⦿ Help integrating PMS outputs into CERs and QMS updates
⦿ Integrate reporting mechanisms across multiple markets
⦿ Map and document conformity with all applicable GSPRs
⦿ Align Risk Management File with ISO 14971 and MDR expectations
⦿ Prepare risk-benefit analysis and risk control summary report
⦿ Ensure integration of risk management with the biological evaluation plan and the software risk management plan
⦿ Develop a Clinical Evaluation Plan (CEP), and a Clinical Evaluation Report (CER) from scratch or validate them
⦿ Support literature review, equivalence justification, and clinical data assessments
⦿ Help design and manage post-market clinical follow-up (PMCF) activities
⦿ Support data collection, reporting, and updates as required
⦿ Establish UDI compliance from scratch
⦿ Assign and manage UDI-DI and UDI-PI in line with EU MDR regulations
⦿ Support registration in EUDAMED and generate Basic UDI-DI
⦿ Prepare and maintain UDI documentation and traceability records
⦿ Ensure ongoing data submission processes meet regulatory expectations
⦿ Prepare and organize your submission package
⦿ Assist with Notified Body selection and contract negotiation
⦿ Respond to Notified Body questions, deficiencies, and CAPA requests during review
⦿ Provide audit readiness training and mock audits and support during external audits
⦿ Building or updating Technical file/Design Dossier
⦿ Establishing labeling, IFU/eIFU, device description, safety, and performance data
⦿ Create traceable documentation structures ready for Notified Body review
At Elexes, we follow a clear, phased approach to make EU MDR compliance efficient and stress-free:
⦿ Discovery: We assess your device classification and business goals
⦿ Roadmap: A tailored MDR compliance plan based on gap analysis
⦿ Documentation: We build or review all required MDR documents
⦿ Submission: We manage the Notified Body process, from submission to approval
⦿ Post-Market: Ongoing support for PMS, vigilance, and compliance updates
From concept to CE Mark—and beyond—we’re with you at every step.
Learn more about our consultant services here.
An EU MDR consultant guides medical device companies through the European Medical Device Regulation (EU MDR 2017/745), supporting classification, documentation, technical files, CE marking submissions, and post-market compliance.
Any medical device or IVD company entering the EU market or transitioning from MDD to MDR benefits from EU MDR consulting. This includes startups, legacy manufacturers, and non-EU entities needing an Authorized Representative.
Key steps include device classification, gap analysis, building technical documentation, CE Mark submission to a Notified Body, and post-market surveillance (PMS) including PSUR and vigilance reporting.
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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