The EU Medical Device Regulation (MDR) 2017/745 represents a significant overhaul of the regulatory landscape for medical devices in the European Union. For manufacturers looking to bring their devices to the EU market, understanding and navigating this complex regulation is critical.
Key Requirements of EU MDR 2017/745
The EU MDR introduces stricter requirements for clinical evidence, post-market surveillance, and technical documentation. Key areas include:
- Clinical Evaluation: More rigorous requirements for clinical data supporting device safety and performance
- Technical Documentation: Enhanced documentation requirements including a Summary of Safety and Clinical Performance (SSCP)
- Post-Market Surveillance: Proactive PMS system with periodic safety update reports (PSURs)
- Unique Device Identification: UDI requirements for device traceability
Steps to Prepare Your Submission
Preparing a successful EU MDR submission requires careful planning and thorough documentation. Our team at Sequence Group has guided numerous manufacturers through this process.
The first step is conducting a gap analysis between your existing technical documentation and the new MDR requirements. This helps identify areas that need improvement before formal submission.
How Sequence Group Can Help
Our regulatory experts have extensive experience with EU MDR submissions and can guide you through every step of the process, from initial assessment through final approval. Contact us today to learn more about our EU MDR submission services.
Frequently Asked Questions
What are the main new requirements that EU MDR 2017/745 introduced compared to the previous directive?
EU MDR 2017/745 introduced stricter clinical evidence requirements demanding data from the specific device rather than relying solely on equivalent devices, enhanced technical documentation including the mandatory Summary of Safety and Clinical Performance (SSCP) for higher-risk devices, a proactive post-market surveillance system with Periodic Safety Update Reports (PSURs), and mandatory Unique Device Identification (UDI) for device traceability throughout the supply chain.
What is the first step in preparing an EU MDR submission?
The recommended first step is conducting a gap analysis between existing technical documentation and the new EU MDR requirements. This identifies areas that need improvement before formal submission and helps manufacturers prioritize their remediation activities. The gap analysis should cover clinical evaluation, post-market surveillance plans, technical documentation structure, and UDI compliance, as these are the areas where the differences from the legacy MDD are most significant.
How has EU MDR affected device classification?
EU MDR introduced changes to device classification rules that resulted in many devices being reclassified to higher risk categories compared to their classification under the Medical Device Directive. A higher risk classification has direct implications for the conformity assessment route required to obtain CE marking, often requiring notified body involvement where self-certification was previously sufficient. Manufacturers should verify their device's classification under EU MDR as an early step in submission planning.