CE Marking Strategy for Medical Devices & IVD
We've guided hundreds of manufacturers to obtain CE marking.
Why CE marking is challenging & How we help
Why CE marking is challenging & How we help
Achieving CE marking under the EU Medical Devices Regulation (MDR) or In Vitro Diagnostics Regulation (IVDR) nowadays requires far more than previous under the old MDD and IVDD directives. It demands robust quality management systems covering the MDR and IVDR requirements for design, production and post market monitoring, comprehensive technical documentation, and rigorous clinical or performance data.
Too many manufacturers discover, often late in the conformity assessment process, that their technical documentation is not covering all regulatory requirements, or their clinical evidence is insufficient. The result is a lengthy conformity assessment, unnecessary Notified Body review rounds, iterations at high costs, and postponed market access. We provide end-to-end CE marking guidance: from regulatory classification and strategy development through technical file compilation. We can act as your Notified Body liaison when needed and help solve non-conformities during the review process. Our deep expertise in MDR and IVDR ensures your submission documentation covers the requirements and the timelines of the conformity assessment process and time to market are minimized.
Satisfied Clients
Our Core CE Marking Services:
Regulatory Strategy & Classification
We determine whether your product qualifies as a medical device or IVD, establish its correct MDR/IVDR classification, and define the conformity assessment route that aligns with your business objectives.
Notified Body Engagement & Submission Support
We assist in selecting and engaging an appropriate Notified Body, preparing submission files, managing queries and responses, and ensuring audit readiness to secure your ISO 13485 and CE certificates.
Technical Documentation Preparation
We develop or review your submission file to meet MDR Annex II/III (or IVDR module) requirements, to ensure completeness, facilitating a smooth review process.
Post-Market Surveillance and Post market Clinical Follow-Up
We establish or enhance your PMS/PMCF (or IVDR performance follow-up) programs for legacy devices. Our experts provide comprehensive support in designing and executing PMCF surveys, ensuring high-quality data collection and analysis to meet regulatory requirements.
Clinical Trials – CRO
When appropriate, we conduct full-scope clinical studies, pre- and post-market, across a variety of therapeutic areas. As a leading contract research organization, we specialize in providing comprehensive services supporting the successful design, development, execution, and management of clinical trials.
Smart regulatory planning accelerates market entry
We take a structured, regulatory-first approach from day one. Our team shapes your regulatory and clinical strategy, delivers practical tools and training, and provides hands-on support. By combining strategic planning and project management, we guide you through the design phase and the submission process, and every step in between.
Smart regulatory planning accelerates market entry
Couldn't find your question?
What exactly is CE marking under MDR/IVDR?
CE marking certifies that your medical device or IVD meets all applicable EU safety, performance, and regulatory requirements, authorizing its sale throughout the European Economic Area.
How do I determine the correct classification and pathway for my device?
Classification depends on risk level, intended use, and device functionality. Our experts conduct this analysis and identify the appropriate conformity assessment route.
Why is a Notified Body required, and how long does the process take?
Apart from Class I Medical devices and non-sterile Class A IVDs, higher-risk devices and IVDs require the involvement of a Notified Body. Timelines vary by device class and complexity; however, well-prepared submissions can significantly reduce the time to certification.
What happens after I receive my CE mark?
CE marking initiates ongoing obligations: post-market surveillance, vigilance reporting, device registration, and periodic recertification. Maintaining these requirements is essential for continued market access.