EU MDR Compliance

EU MDR Compliance

We help medical device companies navigate the complexity of the EU Medical Device Regulation (EU MDR 2017/745) — from initial gap assessments and technical file development to Notified Body submission and ongoing post-market obligations. Whether you are transitioning legacy MDD-certified devices or bringing new products to the European market, we provide the expertise to get you there efficiently and compliantly.

What We Offer

• EU MDR Gap Assessment — We conduct a comprehensive assessment of your current quality system, technical documentation, and clinical evidence against EU MDR requirements — delivering a prioritized remediation roadmap with clear timelines and resource estimates.
• Technical Documentation Development — We author and compile the full technical documentation package required under EU MDR Annexes II and III, including device descriptions, design and manufacturing information, performance and safety data, risk management files, and post-market surveillance documentation.
• Clinical Evaluation Reports (CER) — We develop rigorous Clinical Evaluation Reports in accordance with EU MDR Article 61 and MEDDEV 2.7/1 Rev. 4, including systematic literature reviews, equivalence assessments, and clinical evidence appraisals that meet Notified Body expectations.
• Post-Market Surveillance & PMCF — We develop compliant PMS plans, Post-Market Surveillance Reports (PMSR), Periodic Safety Update Reports (PSURs), and Post-Market Clinical Follow-Up (PMCF) plans and reports — among the most demanding new requirements under EU MDR.
• Declaration of Conformity & Labeling Compliance — We prepare EU Declarations of Conformity and review device labeling, IFUs, and UDI requirements to ensure full compliance with EU MDR Annex I General Safety and Performance Requirements (GSPRs).
• UDI Implementation — We guide you through European UDI requirements, including EUDAMED registration, UDI-DI and UDI-PI assignment, and labeling updates across your product portfolio.
• EUDAMED Registration Support — We assist with actor, device, and certificate registration in the European database for medical devices (EUDAMED), ensuring your submissions are accurate, timely, and complete.
• Notified Body Submission Management — We manage the preparation and submission of conformity assessment dossiers to your Notified Body, coordinate technical responses to queries, and support audit preparation to keep your certification timeline on track.
• QMS Alignment to EU MDR — We assess and update your ISO 13485-based quality management system to address EU MDR-specific requirements, including roles of economic operators, Authorized Representatives, and importers/distributors.
• MDD-to-MDR Transition Support — We provide a structured transition program for legacy MDD-certified devices, prioritizing your portfolio by risk and Notified Body deadline to ensure no disruption to your European market access.

Why It Matters

EU MDR significantly raises the bar for clinical evidence, post-market surveillance, and technical documentation compared to its predecessor, the MDD. Notified Body capacity remains constrained, timelines are long, and the consequences of non-compliance include loss of CE marking and withdrawal from the European market. Companies that begin the transition early with a structured, expert-led approach are far better positioned to maintain market access and avoid costly delays.

Who We Serve

We partner with U.S. and global medical device manufacturers seeking or maintaining CE marking under EU MDR — from small companies entering the European market for the first time to established manufacturers managing large legacy portfolios through the MDD-to-MDR transition.