EU Regulatory Strategy Report

Description:
This document is used to justify and document the EU decisions that drive your CE pathway under the MDR.

• Define Intended use, Indication, Targeted patient population, and Contra-indications to anchor claims and evidence.
• Document EU regulatory strategy expectations per MDR Article 10(9a).
• Justify Product qualification using MDR device definitions (e.g., Medical device, Accessory, Custom-made device).
• Establish Device classification per Annex VIII using Device characteristics and a documented Classification rationale.
• Compare Conformity assessment options and record the Conformity assessment selected.
• Capture Applicable requirements as General requirements plus optional Specific requirements.

Your needs:

• EU regulatory strategy report
• EU regulatory strategy report for MDR decision-making
• Reduce rework and audit risk by locking classification and route early

Use this template when you need a single, traceable EU decision record before drafting technical documentation or engaging a Notified Body under Regulation (EU) 2017/745.

It covers the key MDR decisions end-to-end. Intended use is the manufacturer-defined purpose that drives classification and evidence. A conformity assessment route is the MDR pathway to CE marking based on class and device type:

• Define Intended use and core labeling statements
• Document Product qualification (device/accessory/custom-made/system)
• Describe Device characteristics needed for Annex VIII
• Conclude Classification with a defendable Classification rationale
• Select the Conformity assessment route and record the basis
• Identify Applicable requirements for execution planning

Within Lexqara, we help you translate these decisions into actionable regulatory strategy, QMS alignment, and submission-ready documentation, including review and training support. Explore our Resource Center and our Regulatory Strategy support, and align your approach with EU MDR (Regulation (EU) 2017/745). Request a short gap assessment.

This report becomes your internal “single source of truth” to keep regulatory, clinical, and quality teams aligned throughout development and change control.