Global Market Prep: EU Documentation Basics
Breaking into the European Union market is a milestone for many medical device innovators. But CE marking is just the tip of the iceberg. Sponsors must also demonstrate compliance with the EU Medical Device Regulation (MDR 2017/745), which demands extensive technical documentation and ongoing evidence of safety and performance. The challenge is less about building a great device—and more about proving it in a way that satisfies Notified Body review.
At NMCG, we help clients anticipate, prepare, and streamline their MDR documentation so they can accelerate market entry without costly rework.
Key Documentation Elements for EU Market Entry
1. Technical Documentation (Annex II & III)
The foundation of MDR submissions, this includes device description, design and manufacturing details, risk management files, verification/validation data, and labeling. Documentation must be complete, structured, and kept current throughout the device lifecycle.
The EU MDR 2017/745 full text outlines these requirements in detail.
2. Clinical Evaluation Report (CER)
CERs prove device safety and performance through literature reviews, clinical investigations, and equivalence justifications. MDR raises the bar—requiring robust, ongoing evidence supported by Post-Market Clinical Follow-up (PMCF).
The European Commission’s Medical Device Guidance provides valuable resources on CER expectations and clinical evidence requirements.
Explore our Regulatory Services for CER development and review support.
3. General Safety & Performance Requirements (GSPR) Checklist
Every requirement under Annex I must be addressed with mapped evidence. Even small gaps can halt review. Using guidance from Notified Bodies in the NANDO directory can help interpret compliance expectations.
4. Risk Management File
Aligned with ISO 14971, this file must document proactive risk identification, mitigation, and verification. Reviewers closely scrutinize this alongside the CER.
5. PMS & PMCF Plans
Post-market obligations are more demanding under MDR. Sponsors must outline how they will collect, analyze, and act on real-world safety and performance data—via Post-Market Surveillance (PMS) plans, Post-Market Clinical Follow-up (PMCF) strategies, and periodic safety update reports (PSURs).
Our Clinical Services team builds PMS/PMCF strategies that satisfy EU and global standards.
6. Usability & Human Factors Documentation
Evidence must show usability studies, instructions for use (IFUs), and risk controls against foreseeable misuse.
7. Quality Management System (QMS) Integration
ISO 13485:2016 compliance is essential, particularly for Annex IX conformity assessments that combine full QMS and technical documentation review.
Common Pitfalls to Avoid
Incomplete clinical evidence – relying solely on legacy data or literature equivalence
Vague or misaligned intended purpose – leading to stricter scrutiny
Weak PMS/PMCF plans – treating them as afterthoughts rather than critical evidence
Disorganized submissions – compliant content presented in ways that confuse reviewers
Why It Matters
EU approval delays don’t just stall market entry—they can cascade into reimbursement setbacks, investor concerns, and lost competitive advantage. Preparing MDR-ready documentation early will ensure smoother reviews, stronger credibility, and faster patient access.
At NMCG, we partner with clients to develop: CERs and literature reviews, GSPR checklist gap analyses, risk management and usability documentation, PMS/PMCF strategies, and Notified Body engagement and structured dialogue.
