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EU Declaration of Conformity

Use this EU Declaration of Conformity template to formally declare that your medical device complies with the requirements of the EU Medical Device Regulation (MDR) 2017/745. This document is essential for CE marking and must be completed before placing your device on the European market, serving as proof of conformity and a key part of your technical documentation during audits and regulatory submissions.
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EU Declaration of Conformity

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The EU Declaration of Conformity is issued under the sole responsibility of the manufacturer. This document is a formal statement by the manufacturer that the medical device described below conforms to the requirements of the Medical Device Regulation (MDR) 2017/745.

Manufacturer Information

Legal Manufacturer:

Acme Medical Devices GmbH

Manufacturer Address:

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Regulatory Contact Information

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Medical Device Information

Product/Trade Name:

Medisoft Pro

Software Version:

v2.3.1

Basic UDI-DI:

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Intended Purpose:

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Medical Device Classification Information

Medical Device Class:

Class IIa

Classification Rule Justification:

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Common Specifications

Currently, there are no common specifications that are applicable to this medical device.

Conformity Assessment

According to Article 52, conformity assessment was performed according to Chapters I and III of Annex IX of the Regulation (EU) 2017/745.

Notified Body

TUV Rheinland LGA Products GmbH

The Medical Device referenced above meets the provisions of Regulation (EU) 2017/45 on medical devices. For a full list of applicable technical standards for the device, refer to Annex A.

Name:

Title: CEO

Signature:

Name:

Title: Person Responsible for Regulatory Compliance (PRRC)

Signature:

Annex A - List of Applicable Technical Standards

Medical Device Certification Made Easy.