MDR Gap Assessment Tool – Introduction

MDR ToolMy name is Michael Galliker and in January 2017 I finished my Master of Advanced Studies in-MedTec. In context with my master thesis (master thesis of the year 2017, Bern University) and my experience in regulatory affairs I have developed a gap analysis tool which helps to implement the new medical device regulation (MDR) into the company I’m working for. As you are aware, the European medical device industry will undergo significant change as a result of the new medical device regulation which is currently finalised since May 26th, 2017. As the name suggests, it is a regulation and no longer a directive and all medical device companies have to adhere to this new regulation. Companies not following the new rules will no longer be allowed to sell their medical products in the European Union. This legislation change have a big influence on European businesses. In order to find all gaps within a company a complete gap analysis is required. This is exactly where my Excel based gap analysis tool will be of great support and will find all gaps immediately.

Now

Step1

Gap Analysis

2024 May – 2025

Step2

Implementation, Verification

May 2026 -2028

Step3

Receive of the MDR certificate

Tool Description

The goal of the EU MDR and EU IVDR Tool is to develop digital products that help medical companies such as manufacturers, distributors, importers, authorized representatives, or consultants to easily implement the new MDR and IVDR regulations.

Our products are based on Word or Excel and are designed to require no additional IT knowledge. Just download and start!!!!

Should you have any questions or require additional information, please don’t hesitate to contact me directly by mail or by phone.

Download

MDR Gap-Tool FREE VERSION (English)

This Excel version does not include the complete medical device regulation. It will give you just a brief overview of how the tool works.

Click here

MDR Gap-Tool free Version (English)

If you do not opt for our News Letter, we will delete your data according to the new GDPR regulation.

You will receive important information about MDR, ISO 13485: 2016, MDSAP and our tools. You will get maximum two News Letters each month.

Please wait...

MDR Gap-Tool FULL VERSION (English)

This Excel version includes the complete medical device regulation (EU 2017/745, English version of 20 March 2023 + the last amendment Regulation EU 2024/1860). Compatible with: Excel version 2010, 2013, 2016 and higher.

Click here

MDR Gap-Tool free Version (English)

If you do not opt for our News Letter, we will delete your data according to the new GDPR regulation.

You will receive important information about MDR, ISO 13485: 2016, MDSAP and our tools. You will get maximum two News Letters each month.

Please wait...

IVDR Gap-Tool FREE VERSION (English)

This Excel version does not include the complete IVDR. It will give you just a brief overview of how the tool works.

Click here

IVDR Gap-Tool Free Version (English)

If you do not opt for our News Letter, we will delete your data according to the new GDPR regulation.

You will receive important information about MDR, ISO 13485: 2016, MDSAP and our tools. You will get maximum two News Letters each month.

Please wait...

IVDR Gap-Tool FULL VERSION (English)

This Excel version includes the complete IVDR (EU 2017/746, English version of 20 March 2023 + the last amendment Regulation EU 2024/1860). Compatible with: Excel version 2010, 2013, 2016 and higher.

Click here

IVDR Gap-Tool Free Version (English)

If you do not opt for our News Letter, we will delete your data according to the new GDPR regulation.

You will receive important information about MDR, ISO 13485: 2016, MDSAP and our tools. You will get maximum two News Letters each month.

Please wait...
PDF Version: Classification Form, MDR Annex VIII (English):

Note: Template (Word Version) is included in the MDR Gap-Analysis FULL Version or can be downloaded below as single Word Version.

Word Version: Classification Form, MDR Annex VIII (English)

This English Word Version includes the complete Annex VIII (classifiaction rules) and is the ideal template for your company. Compatible with: Word version 2010, 2013, 2016 and higher.

Buy now
PDF Version: Classification Form, MDR Annex VIII (German):

Note: Template (Word Version) is included in the MDR Gap-Analysis FULL Version or can be downloaded below as single Word Version.

Word Version: Classification Form, MDR Annex VIII (German)

This German Word Version includes the complete Annex VIII (classifiaction rules) and is the ideal template for your company. Compatible with: Word version 2010, 2013, 2016 and higher.

Buy now

Service

Regulatory Globe offers many other helpful tools. Click here to see our other tools.

  • Contact us directly and we will send you a questionnaire
  • Fill out the questionnaire and send it back to us
  • We will send you an offer within 48 hours

Contact us

Feel free to contact us

Please wait...

Helpful Links and News

Medical Device News by Regulatory Globe:

Link to News

EUR-Lex:

Download EU 2017/745 (all languages)

Update: July 9th, 2024

EU MDR and EU IVDR amending EU 2024/1860:

For more information CLICK HERE!!!

   

Update: May 30th, 2024: MDR Implementation Guide

For more information CLICK HERE!!!

MDR Implementation Guide

 

FAQ

  • What is the first step after downloading?

    First, go to page “dropdown” in the Excel tool and fill in the following three columns with your own information: Process, Department, Responsibility (the blue text is just an example and should be deleted).
  • What are the MDR ID and IVDR ID columns?

    These are unique ID numbers.

Our Customers