The Ultimate Guide to EU MDR Transition

Introduction

The transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) is the most significant regulatory change in Europe in decades. It impacts every aspect of the device lifecycle, from clinical evaluation to post-market surveillance.

Key Changes

1. Classification Rules

Many devices are being up-classified, requiring stricter conformity assessment procedures. Software, in particular, faces new classification rules (Rule 11) that may push Class I devices into Class IIa or higher.

2. Clinical Evidence

Grandfathering is effectively dead. Even legacy devices with years of safe use must provide robust clinical data. The concept of "equivalence" has been significantly narrowed.

3. EUDAMED

The new European database on medical devices (EUDAMED) will increase transparency but also the administrative burden on manufacturers.

Strategic Roadmap

To navigate this transition successfully, manufacturers must:

• Conduct an immediate portfolio audit.
• Update Clinical Evaluation Reports (CERs).
• Implement a proactive Post-Market Surveillance (PMS) system.

[Download the full PDF] to get our step-by-step checklist.