EU MDR Consultants for Medical Device CE Marking

Any company involved in the development, manufacturing, or distribution of medical devices intended for affixing CE Logo on the device or planning to export to Europe may benefit from our EU MDR Consultants. This includes startups, small, medium and even large corporations.

Manufacturers lacking experienced staff for technical file preparation and clinical evaluation report review may engage EU MDR Consulting Services. First-time applicants are advised to use EU MDR Consulting Services to streamline the process and expedite documentation and implementation. Our MDR Consultants can greatly enhance the likelihood of achieving compliance and obtaining successful certification.

EU MDR consultants don’t add cost – they prevent unnecessary cost. I3CGlobal helps manufacturers achieve compliance faster, smarter, and more economical!

Appointing an EU MDR consultant doesn’t increase your costs; it significantly reduces them.

Many manufacturers assume that hiring big consulting firms like I3CGlobal will inflate budgets. In reality, the opposite is true. Proper regulatory planning and a well-developed Technical File with full GSPR compliance eliminate unnecessary testing, avoid repeat clinical studies, and prevent costly rework.

Instead of hiring freelance individuals with limited expertise or hiring high salaried, experienced professionals for MDR process, manufacturers gain instant access to a multidisciplinary expert team. Technical documentation is completed faster and more accurately by multiple specialists without long-term salary commitments.

By partnering with multidisciplinary team of regulatory, clinical, and quality experts from I3CGlobal, your internal teams stay focused on core business and day-to-day operations, while our experts manage MDR compliance efficiently, correctly, and cost-effectively. The result: faster MDR CE approval, lower overall cost, and reduced regulatory risk.

Performing an MDR Gap Analysis early helps manufacturers avoid certification delays, reduce Notified Body findings, improve the quality of Technical Documentation, prepare realistic project timelines, minimize regulatory risks, and maintain continuous access to the European Union market.

Technical Documentation is one of the most important requirements under EU MDR 2017/745. Many manufacturers face challenges because their existing files are incomplete, outdated, or not fully compliant with current regulatory requirements. Technical documentation  and file remediation helps identify these gaps and update the documentation to meet regulatory expectations.

Our team supports manufacturers in reviewing and remediating Technical Files according to EU MDR Annex II and Annex III requirements. This includes updating device descriptions, intended use, GSPR checklists, risk management files, Clinical Evaluation Reports (CER), PMS documentation, PMCF documents, labeling, IFU, verification and validation data, and other supporting records required for regulatory compliance.

We help manufacturers improve the quality, structure, and completeness of their Technical Documentation to reduce Notified Body findings, support smoother audits and submissions, and maintain continued market access in the European Union and other global markets.

If you have ever tried to get a medical device CE marked under EU MDR, you will know that clinical evidence is where most manufacturers hit a wall. The Clinical Evaluation Report (CER) is the document your Notified Body will scrutinize most closely. It has to show, clearly and convincingly, that your device is safe and that it performs the way you say it does. Not in theory. In practice, with real patients.

To build that case, your clinical team works through a Literature Review going through published medical studies, clinical trial data, and peer-reviewed research to find every relevant piece of evidence that exists for your device and the clinical area it sits in. The stronger and more thorough that search, the stronger your CER.

Most manufacturers underestimate how much work this takes and how unforgiving Notified Bodies have become since MDR replaced MDD. A CER that passed scrutiny five years ago would likely not pass today. Getting both documents right the first time saves months of back-and-forth with your Notified Body and keeps your CE Marking timeline on track.

Getting a CE Mark is necessary for selling medical devices in Europe. It shows that the device follows EU safety, health, and performance requirements under EU MDR 2017/745. At I3CGLOBAL, we help manufacturers understand and complete the CE Marking process in a simple and organized way.

Our team supports manufacturers from the beginning of the project until final certification and market access. We help reduce delays, improve documentation quality, and support companies during Notified Body reviews to make the CE certification process smoother and easier.

Gap Analysis & Strategy: We identify MDR compliance gaps and help manufacturers choose the correct and fastest path for CE certification, including MDD to MDR transition support.

Technical Documentation: We prepare and review Technical Files, Design Dossiers, and other MDR documents required for Notified Body submissions and audits.

Clinical Investigation (Prospective and Retrospective – PMCF studies): We prepare and review Technical Files, Design Dossiers, and other MDR documents required for Notified Body submissions and audits.

Quality Management Systems (QMS): We support implementation and auditing of ISO 13485:2016 compliant Quality Management Systems for medical device manufacturers.

Authorized Representation: We provide EU Authorized Representative (EAR) services for manufacturers located outside the European Union.

Notified Body Liaison: We help manage submissions, communication, and follow-up activities with European Notified Bodies during the CE certification process.

Getting your device classification right is the first and most important step in your EU MDR 2017/745 compliance journey. Devices are categorized into Class I, IIa, IIb, and Class III based on their intended purpose, duration of use, and the level of risk they present to the patient.

EU MDR introduced stricter classification rules compared to MDD, particularly for software (Rule 11), implants, and substance-based devices. Many products that sat in a lower risk class under MDD have been up-classified under MDR, which directly affects the level of Notified Body involvement and the depth of technical documentation required.

Getting the classification wrong at the start creates costly delays later. Our consultants apply all 22 MDR classification rules to your specific device making sure your regulatory strategy is built on the right foundation from day one.

I3CGlobal locations are ISO 13485 Certified and data security certified to ISO 27001, which demonstrates our commitment to overall quality and document security in our customer service operations. Our EU MDR Consultants, Leads and Managers are responsive to answering customer technical emails within 24 hours, as it demonstrates our timely communication.

Generally, we at I3CGlobal help manufacturers navigate and document the complex regulatory requirements of any type and class of device and ensure the Notified Body approval on time, thereby without description the products can be sold in the EU territory.

CE Marking is not the finish line, it is the starting point. Under EU MDR 2017/745, manufacturers must continuously monitor how their device performs in the real world, throughout its entire lifecycle. At I3CGlobal, we build PMS systems that are practical, compliant, and tailored to your device’s risk class. We develop your PMS Plan and PMS Reports, prepare Periodic Safety Update Reports (PSURs) for higher-risk devices, and design Post-Market Clinical Follow-Up (PMCF) programmes that close clinical evidence gaps identified in your CER.

When incidents happen, we manage the full vigilance process, from assessing whether an event is reportable, to submitting notifications to EUDAMED and National Competent Authorities on your behalf. Whether you are setting up PMS for the first time or strengthening an existing system, our team keeps you audit-ready at every stage.