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EU MDR Must-Have Documents Template


When it comes to the distribution of medical products in the EU, there are certain protocol and requirements that must be met per their standard, for safety and quality reasons. Along with following these standards, there are certain items that must be documents in accordance with the EU MDR regulations. There are several documents that are not necessary to record, but many that are vital in order to cooperate with the requirements of the EU MDR. This coherent EU MDR Documents Template will guide you in knowing which items must be documented as per the European Union standard. Using this template along with other resources Lumiform has to offer, like our Digital Documentation App that will keep all of your data accessible and consistent across your entire team, for the most accurate results.

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EU MDR Must-Have Documents Template

General:

EU Declaration of Conformity

QMS (Quality Management System)

UDI-DI

Safety Performance Summary

Clinical Performance Summary

Risk Management:

Plan

File

Report

Clinical Evaluation:

Plan

Report

Clinical Investigation:

Informed Consent

Application Form

Investigator Pamphlet

Plan

Safety Statement

Performance Statement

Proof of Insurance

Description of Arrangements

Report

Post-Market Surveillance:

Plan

Report

Periodic Safety Update Report

Clinical Follow-Up Plan

Vigilance

Field Safety Corrective Actions

Adverse Event Report

Technical File Documents

Device Description

Device Specification

Instructions of Use

Labels

Design Info

Manufacturing Process

Validations

Site ID

Results of Testing (Pre/Clinical)

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