EU MDR Implementation

EU MDR Implementation medical device industry will undergo significant changes as a result of the new medical device regulation which has signed on May 26th, 2017. As the name suggests, is it a regulation and no longer a directive and all medical device companies that sell medical products in Europe have to adhere to this new regulation.

Companies that do not follow this regulation will no longer be allowed to sell their medical products in the European Union after May 26th, 2020. Depending on your role as economic operator (manufacturer, importer, authorized representative, distributor) the impact can be meaningful.

EU MDR IMPLEMENTATION

Below you will find a step-by-step EU MDR IMPLEMENTATION guide with regards to the new medical device regulation (MDR EU2017/745). Our guide is simple to understand and will allow you to save time and money when implementing the new regulation.

DEVICE CLASSIFICATION:

In a first step you should check if the new MDR rules have any impact on your existing or future products classifications.

ECONOMIC OPERATORS:

Depending on your business you may have one or multiple economic operator responsibilities, which is imperative to know before you start with the gap assessment. Economic operators are Manufacturers, Importers, Distributors or Authorized Representative. Each of them has different requirements to fulfill per the EU MDR IMPLEMENTATION

GAP ASSESSMENT 

Step 1

Reduce not required information by going through the chapters and annexes and eliminate all not required information.

Step 2

Define keywords which are not applicable to you. In our MDR tool you have the opportunity to search for these keywords.

Step 3

Go through all open requirements step by step and define if requirements are relevant for your business or not.

IMPLEMENTATION:

Prior to starting the implementation phase, you should put a plan in place. The steps below will guide you through the main topics.

• Safety and performance checklist

• Technical File

• Risk management according to ISO 14971

• UDI System

• Post-Market Surveillance (PMS)

• Post-Market Clinical Follow-Up (PMCF)

• Clinical Evaluation

• Labelling

• EUDAMED (European database on medical devices)

• Common Specifications

VERIFICATION / IMPROVEMENT

Performing internal audits and a final mock audit to ensure the key requirements have been implemented.

FINAL CHECKLIST:

Make a final “written” checklist, where you can show the evidence for each requirement. 

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If  You Want Medical Devices Services Consultation For Following.

1. Medical Device Consulting 
2. cdsco registration 
3. FDA 510k Clearance 
4. ce mark medical device 
5. CDSCO Manufacturing License 
6. CDSCO import license 
7. TURNKEY PROJECT CONSULTANT 
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11. ISO 13485 Medical Device Consultant 
12. Primary Packaging Turnkey Project Consultant 
13. Clean Room Design Consultant 
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27. Cdsco India authorized agent for medical device